<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02982213</url>
  </required_header>
  <id_info>
    <org_study_id>STU00203896</org_study_id>
    <nct_id>NCT02982213</nct_id>
  </id_info>
  <brief_title>Presence of a Companion During Performance of Neuraxial Labor Analgesia</brief_title>
  <acronym>Companion</acronym>
  <official_title>Presence of a Companion During Performance of Neuraxial Labor Analgesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwestern University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to evaluate if maternal anxiety is improved when a parturient&#xD;
      gets her choice with regard to the presence of a companion during epidural catheter placement&#xD;
      for labor analgesia. It will be focused on parturients having their first child with the&#xD;
      current partner. Additionally, it will investigate the effect of ethnicity, health literacy&#xD;
      (as evaluated by the Newest Vital Sign questionnaire), catastrophizing (as evaluated by the&#xD;
      Pain Catastrophizing Scale), and the relationship of the support person to the parturient.&#xD;
      The investigators hypothesize that there may be specific subgroups in which maternal anxiety&#xD;
      is improved when a parturient gets her choice regarding the presence of a companion during&#xD;
      labor epidural catheter placement; however, a significant improvement in maternal anxiety,&#xD;
      when including all participants, will not be appreciated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Parturients who have been admitted to the Labor and Delivery ward at Prentice Women's&#xD;
      Hospital will be approached by a member of the anesthesia team prior to the placement of a&#xD;
      labor epidural catheter. They will be asked if they are considering neuraxial labor&#xD;
      analgesia, and if they are they will be screened using the inclusion and exclusion criteria&#xD;
      to determine study eligibility. Once they have been evaluated and found to be appropriate for&#xD;
      the study, they will be invited to participate.&#xD;
&#xD;
      Participants will be asked to fill out the STAI questionnaire to assess the level of anxiety&#xD;
      prior to placement of the labor epidural catheter, and before knowing their group assignment.&#xD;
      They will then complete the pre procedure questionnaire. This questionnaire asks about&#xD;
      expectations she has for the labor epidural procedure. They will then be given the page of&#xD;
      the Newest Vital Signs questionnaire with the Nutrition Facts, and be asked the 6 questions&#xD;
      by the recruiter. Then they will be handed the Pain Catastrophizing Scale form with 13&#xD;
      statements, and asked to fill it out as directed in the instructions at the top. They will&#xD;
      then be asked who their primary support person is. A form will be handed to that person to&#xD;
      confidentially record if he/she would prefer to be present for the procedure. This form will&#xD;
      be collected from the companion, and without the parturient aware of the support person's&#xD;
      response, she will be asked for her preference with regard to the presence of a companion in&#xD;
      the room, which will be recorded on this form as well. Finally, she will be asked which&#xD;
      ethnicity she most relates to, also to be recorded on this form.&#xD;
&#xD;
      After all these data have been collected, the parturient will be randomized as to whether her&#xD;
      companion will be allowed in the room or will be asked to leave. This will not be&#xD;
      communicated to the parturient until the time of the labor epidural catheter placement. When&#xD;
      she requests the neuraxial labor analgesia, the provider placing the labor epidural catheter&#xD;
      will be made aware of which group she has been randomized to, and will either ask the&#xD;
      companion to leave for placement, or provide the support person a non-mobile chair to sit on&#xD;
      in front of the parturient for placement of the labor epidural. The companion will be asked&#xD;
      to remain in the chair. He/she will be asked to focus on the parturient. It will be&#xD;
      emphasized that he/she must remain seated and will not be allowed to observe the procedure&#xD;
      being performed. This is to prevent loss of consciousness in the support person, which has&#xD;
      been documented in the literature (Devore and Asrani, 1978; Crosby and Halpern, 1989). One&#xD;
      violation will result in a warning, and after a second the companion will be escorted out of&#xD;
      the room and the participant will be removed from the study.&#xD;
&#xD;
      The provider will place the labor epidural catheter in the regular fashion, as is common&#xD;
      practice at Prentice Women's Hospital. After preparation and draping of the skin in the&#xD;
      sitting position, infiltration with Lidocaine 1% will be conducted at L3-L4 or L4-L5. A 17g&#xD;
      Tuohy needle will be advanced into the epidural space, using a loss of resistance with either&#xD;
      saline or air, depending on the provider's preference. After the epidural space has been&#xD;
      located, a 27g pencil-tip spinal needle will be placed through the Tuohy, into the&#xD;
      intrathecal space, and an intrathecal dose of medication will be administered. The exact dose&#xD;
      to be injected will be left up to the discretion of the provider, who will determine the&#xD;
      appropriate dose based on the patient's situation at that time. After the intrathecal dose is&#xD;
      administered, the spinal needle will be removed and a 19g epidural catheter will be placed&#xD;
      through the Tuohy into the epidural space. It will be secured at the skin with a sterile&#xD;
      dressing and tape, leaving 5cm of the catheter in the epidural space. The patient will then&#xD;
      be placed in a lateral position.&#xD;
&#xD;
      After the completion of the neuraxial procedure, the study participant will then be asked to&#xD;
      fill out the STAI questionnaire again. Additionally, she will be asked to record her&#xD;
      perception of pain during the placement of the labor epidural catheter, using a VAS (Visual&#xD;
      Analogue Scale) from 0-100mm. At that point the parturient's participation in the study will&#xD;
      be complete.&#xD;
&#xD;
      The provider placing the labor epidural catheter will be asked to evaluate his/her ability to&#xD;
      palpate landmarks for placement, the positioning of the patient, and overall perceived&#xD;
      difficulty with the epidural placement, using a VAS from 0-100mm for each, which will be kept&#xD;
      confidential.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2016</start_date>
  <completion_date type="Actual">April 1, 2017</completion_date>
  <primary_completion_date type="Actual">April 1, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maternal Satisfaction and the Presence of a Companion During the Placement of Epidural Catheter for Labor Analgesia.</measure>
    <time_frame>Average 12 hours, up to 24 hours after epidural placement</time_frame>
    <description>The maternal satisfaction after epidural catheter placement for labor analgesia and the presence of a companion scored on a 5 point Likert scale of Highly Dissatisfied, Dissatisfied, Neutral, Satisfied and Highly Satisfied</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Does the Desire of Subject to Have the Companion Present Affect the Anxiety of the Subject Measured Using the STAI (State-Trait Anxiety Inventory) Questionnaire.</measure>
    <time_frame>24 hours after epidural placement</time_frame>
    <description>Analysis of maternal anxiety, pre and post placement of the epidural catheter, using the STAI questionnaire.The STAI is a two part 20 question per part anxiety scale survey. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. The State-Trait Anxiety Inventory (STAI) is used to measure of trait and state anxiety. There are 20 items for assessing trait anxiety and 20 for state anxiety. Both tests are scored on a 4-point scale (from &quot;Almost Never&quot; to &quot;Almost Always&quot;). Score limit for each test is 20 low to 80 high. Low to mild anxiety is a score of 20-37, moderate anxiety is a score of 38-44 and high anxiety is a score of 45-80. The score represents the difference between the pre STAI and the post procedure STAI in each group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Does the Presence of a Companion Affect the Perceived Difficulty of the Procedure by the Resident Physician Placing the Labor Epidural Catheter.</measure>
    <time_frame>After epidural placement</time_frame>
    <description>Analysis of the perceived difficulty for the anesthesia resident physician, through utilization of a scale of 0 (severe discomfort to 10 (extremely comfortable).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>What is the Preference of Subjects to Have a Companion Present for Future Procedures.</measure>
    <time_frame>24 hours after epidural placement</time_frame>
    <description>What is the preference of subjects having a companion present using 5 point Likert like scale of highly unlikely to highly likely.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recommend Care Received Based on Experience of Companion Presence in Room During Epidural Procedure.</measure>
    <time_frame>24 hours after epidural</time_frame>
    <description>Recommend care based on presence or absence of a companion received based on Likert type scale of highly unlikely to highly likely.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Anxiety</condition>
  <condition>Pain</condition>
  <condition>Health Knowledge, Attitudes, Practice</condition>
  <arm_group>
    <arm_group_label>No companion present</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No companion is present during the placement of the epidural catheter.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Companion present</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A companion will be present during the placement of the epidural catheter.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Companion Present</intervention_name>
    <description>A companion will be present during the epidural catheter placement.</description>
    <arm_group_label>Companion present</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Delivering the first child&#xD;
&#xD;
          -  Planning to labor with neuraxial analgesia.&#xD;
&#xD;
          -  Additionally, there will need to be sufficient time before delivery to allow the&#xD;
             completion of the Pre procedure questionnaire, State-Trait Anxiety Inventory (STAI)&#xD;
             questionnaire both before and after the procedure, as well as the Newest Vital Sign&#xD;
             questionnaire and the Pain Catastrophizing Scale questionnaire before the procedure.&#xD;
&#xD;
          -  They will be included if they are ASA (American Society of Anesthesiologists) 2.&#xD;
&#xD;
          -  Able to read and comprehend the English language, as the Newest Vital Sign&#xD;
             questionnaire requires them to read and interpret a nutrition label.&#xD;
&#xD;
        Physician Inclusion:&#xD;
&#xD;
          -  Anesthesiology Attending Physician, fellow or resident who participants in the&#xD;
             placement of the epidural catheter placement&#xD;
&#xD;
        Companion Inclusion:&#xD;
&#xD;
          -  Primary companion identified by parturient over the age of 18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Parturients will be excluded if they are receiving neuraxial anesthesia for a cesarean&#xD;
             delivery,&#xD;
&#xD;
          -  External cephalic version&#xD;
&#xD;
          -  Non-labor procedure.&#xD;
&#xD;
          -  Subjects will be excluded if they begin to push for delivery before completion of the&#xD;
             STAI questionnaire following labor epidural catheter placement.&#xD;
&#xD;
          -  They will be excluded if there is no support person present at the time of the&#xD;
             neuraxial procedure.&#xD;
&#xD;
          -  They will be excluded if they are ASA 3 or greater, or if they have a contraindication&#xD;
             to receiving any of the medications routinely used in the placement of a labor&#xD;
             epidural catheter (lidocaine, bupivacaine, epinephrine, fentanyl).&#xD;
&#xD;
          -  Adults who are unable to consent and minors will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Feyce Peralta, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Prentice Women's Hospital</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <results_first_submitted>July 11, 2019</results_first_submitted>
  <results_first_submitted_qc>January 5, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">January 26, 2021</results_first_posted>
  <last_update_submitted>November 11, 2021</last_update_submitted>
  <last_update_submitted_qc>November 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Feyce M. Peralta, MD, MS</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Newest Vital Sign</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Health literacy</keyword>
  <keyword>Neuraxial Analgesia</keyword>
  <keyword>Epidural catheter placement</keyword>
  <keyword>Pregnancy</keyword>
  <keyword>Parturients</keyword>
  <keyword>Pain Catastrophizing Scale</keyword>
  <keyword>STAI questionnaire</keyword>
  <keyword>Companion</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 11, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT02982213/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>No Companion Present</title>
          <description>No companion is present during the placement of the epidural catheter.</description>
        </group>
        <group group_id="P2">
          <title>Companion Present</title>
          <description>A companion will be present during the placement of the epidural catheter.&#xD;
Companion Present: A companion will be present during the epidural catheter placement.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="75"/>
                <participants group_id="P2" count="75"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="70"/>
                <participants group_id="P2" count="74"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Did not complete follow up questionnaire</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>In the companion not in the room group, 73 subjects received the intervention and 70 completed follow up.&#xD;
In the companion in the room group, 75 completed demographic data, 73 subjects received intervention and 74 completed follow up.</population>
      <group_list>
        <group group_id="B1">
          <title>No Companion Present</title>
          <description>No companion is present during the placement of the epidural catheter.</description>
        </group>
        <group group_id="B2">
          <title>Companion Present</title>
          <description>A companion will be present during the placement of the epidural catheter.&#xD;
Companion Present: A companion will be present during the epidural catheter placement.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="75"/>
            <count group_id="B2" value="75"/>
            <count group_id="B3" value="150"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>In the companion not in the room group, 73 completed demographic data, 73 subjects received the intervention and 70 completed follow up.In the companion in the room group, 75 completed demographic data, 75 subjects received intervention and 74 completed follow up.</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                    <count group_id="B2" value="75"/>
                    <count group_id="B3" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.2" spread="3.8"/>
                    <measurement group_id="B2" value="31.8" spread="3.6"/>
                    <measurement group_id="B3" value="32" spread="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="75"/>
                    <count group_id="B2" value="75"/>
                    <count group_id="B3" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="75"/>
                    <measurement group_id="B2" value="75"/>
                    <measurement group_id="B3" value="150"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Caucasian</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="75"/>
                    <count group_id="B2" value="75"/>
                    <count group_id="B3" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>African American</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="75"/>
                    <count group_id="B2" value="75"/>
                    <count group_id="B3" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="75"/>
                    <count group_id="B2" value="75"/>
                    <count group_id="B3" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Latino/Hispanic</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="75"/>
                    <count group_id="B2" value="75"/>
                    <count group_id="B3" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question not answered</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="75"/>
                    <count group_id="B2" value="75"/>
                    <count group_id="B3" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="75"/>
                    <count group_id="B2" value="75"/>
                    <count group_id="B3" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="75"/>
                    <measurement group_id="B2" value="75"/>
                    <measurement group_id="B3" value="147"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index</title>
          <units>kg/m2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="75"/>
                    <count group_id="B2" value="75"/>
                    <count group_id="B3" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.2" spread="4.7"/>
                    <measurement group_id="B2" value="29.6" spread="7.3"/>
                    <measurement group_id="B3" value="29.4" spread="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gestational Age</title>
          <population>In the companion not in the room group 72 completed gestational data and in the companion group 73 completed the gestational data. .</population>
          <units>Weeks</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="72"/>
                    <count group_id="B2" value="73"/>
                    <count group_id="B3" value="145"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40" lower_limit="39" upper_limit="41"/>
                    <measurement group_id="B2" value="40" lower_limit="39" upper_limit="41"/>
                    <measurement group_id="B3" value="40" lower_limit="39" upper_limit="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>NRS pain score</title>
          <description>Numerical Rating Scale (NRS) pain score (0 no pain to 10 worst pain imaginable) at request for neuraxial analgesia</description>
          <population>73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7" lower_limit="6" upper_limit="8"/>
                    <measurement group_id="B2" value="7" lower_limit="6" upper_limit="8"/>
                    <measurement group_id="B3" value="7" lower_limit="6" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cervical Dilation</title>
          <description>Cervical dilation in centimeters.</description>
          <population>73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed .</population>
          <units>centimeters</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3" lower_limit="2" upper_limit="4"/>
                    <measurement group_id="B2" value="3.5" lower_limit="2" upper_limit="4.5"/>
                    <measurement group_id="B3" value="3" lower_limit="2" upper_limit="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Labor Type</title>
          <population>73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Induction</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spontaneous labor</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Labor epidural procedural expectations</title>
          <population>73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>None</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Short procedure minimal pain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Long procedure pain not mentioned</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Painful procedure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other than pain or duration</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Greatest concern regarding epidural procedure</title>
          <population>73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Pain during procedure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                    <count group_id="B2" value="75"/>
                    <count group_id="B3" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unable to tolerate procedure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                    <count group_id="B2" value="75"/>
                    <count group_id="B3" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ineffective analgesia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                    <count group_id="B2" value="75"/>
                    <count group_id="B3" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Complications</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                    <count group_id="B2" value="75"/>
                    <count group_id="B3" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                    <count group_id="B2" value="75"/>
                    <count group_id="B3" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Have you spoken to friends or family about labor epidurals?</title>
          <population>73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Yes-positive comments</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yes-mixed comments</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yes-mostly negative comments</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Did not respond</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Researched epidurals through social media?</title>
          <population>73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Relationship of primary companion</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Male partner</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="75"/>
                    <count group_id="B2" value="75"/>
                    <count group_id="B3" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="65"/>
                    <measurement group_id="B3" value="127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Female partner</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="75"/>
                    <count group_id="B2" value="75"/>
                    <count group_id="B3" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Brother</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="75"/>
                    <count group_id="B2" value="75"/>
                    <count group_id="B3" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aunt</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="75"/>
                    <count group_id="B2" value="75"/>
                    <count group_id="B3" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Friend</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="75"/>
                    <count group_id="B2" value="75"/>
                    <count group_id="B3" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>How long have you known your companion (years)?</title>
          <population>73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)</population>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.5" lower_limit="6" upper_limit="11"/>
                    <measurement group_id="B2" value="7" lower_limit="5" upper_limit="11"/>
                    <measurement group_id="B3" value="7" lower_limit="5" upper_limit="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Work in medical field?</title>
          <population>73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                    <measurement group_id="B2" value="62"/>
                    <measurement group_id="B3" value="123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Preprocedure pain catastrophizing scale</title>
          <description>The PCS is a self reported 13 item scale, with each item rated on a 5-point scale: 0 (Not at all) to 4 (all the time). The PCS is contains three subscales being magnification, rumination, and helplessness. Possible score is 0-52 where the higher scores indicate that the more catastrophizing thoughts are present. Catastrophizing thinking can result in a more intense experience of pain.</description>
          <population>73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <title>Median (quartile)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12" lower_limit="8" upper_limit="22"/>
                    <measurement group_id="B2" value="17" lower_limit="11" upper_limit="22"/>
                    <measurement group_id="B3" value="14" lower_limit="8" upper_limit="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Upper (quartile)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18" lower_limit="18" upper_limit="25"/>
                    <measurement group_id="B2" value="23" lower_limit="23" upper_limit="31"/>
                    <measurement group_id="B3" value="21" lower_limit="18" upper_limit="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Newest vital sign</title>
          <description>The Newest Vital Sign (NVS), is a nutrition label is accompanied by 6 questions. Answering more than 4 correct responses are unlikely to have low literacy, whereas answering fewer than 4 correct answers indicate the possibility of limited literacy. Possible score 0 low health literacy-6 high health literacy.</description>
          <population>74 in the partner in the room group were analysed (1 emergency cesarean delivery).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="75"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="149"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Good health literacy</title>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="65"/>
                    <measurement group_id="B3" value="127"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Low health literacy</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>State-Trait (STAI) Anxiety Inventory</title>
          <description>The State-Trait Anxiety Inventory (STAI) is used to measure of trait and state anxiety. There are 20 items for assessing trait anxiety and 20 for state anxiety. Both tests are scored on a 4-point scale (from &quot;Almost Never&quot; to &quot;Almost Always&quot;). Score limit for each test is 20 low to 80 high. Low to mild anxiety is a score of 20-37, moderate anxiety is a score of 38-44 and high anxiety is a score of 45-80.</description>
          <population>73 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery)</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <title>State</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38" lower_limit="31" upper_limit="46"/>
                    <measurement group_id="B2" value="38" lower_limit="32" upper_limit="50"/>
                    <measurement group_id="B3" value="38" lower_limit="31" upper_limit="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Trait</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29" lower_limit="26" upper_limit="35"/>
                    <measurement group_id="B2" value="31" lower_limit="26" upper_limit="37"/>
                    <measurement group_id="B3" value="30" lower_limit="26" upper_limit="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Labor Epidural Performance: Trainee Level</title>
          <description>Physician training level of the operator of the epidural placement catheter.</description>
          <population>Training level of operator for the epidural catheter placement CA1-CA3 = clinical anesthesiology training year.&#xD;
70 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section 3 no follow up)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Clinical Anesthesia 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="70"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="144"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical Anesthesia 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="70"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="144"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical Anesthesia 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="70"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="144"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fellow</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="70"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="144"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants Categorized by Number of Epidural Catheter Attempts</title>
          <population>70 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section 3 no follow up)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>1 Attempt</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="70"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="144"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                    <measurement group_id="B2" value="65"/>
                    <measurement group_id="B3" value="124"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Attempts</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="70"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="144"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Attempts not recorded</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="70"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="144"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Attending Anesthesiologist Takeover of Epidural Placement</title>
          <population>70 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section 3 no follow up)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery).</population>
          <units>Attending Takeovers</units>
          <param>Number</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="70"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="144"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Resident Assessment of Difficulty of Epidural Procedure</title>
          <description>Difficulty of procedure scored on a scale of 0 (extremely difficult) to 100 (not difficult).</description>
          <population>70 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section 3 no follow up)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery).</population>
          <units>Score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="70"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="144"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="80" lower_limit="50" upper_limit="90"/>
                    <measurement group_id="B2" value="78" lower_limit="44" upper_limit="90"/>
                    <measurement group_id="B3" value="79" lower_limit="44" upper_limit="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Resident Assessment of Ability to Position Patient (0-100)</title>
          <description>The operator (resident) assessment of the difficulty of preparing the patient for positioning prior to the epidural catheter placement scored on a scale of 0 (difficult) to 100 (easy).</description>
          <population>70 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section and 3 no follow up) and 74 in the partner in the room group were analysed (1 emergency cesarean delivery).</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="70"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="144"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="77" lower_limit="65" upper_limit="90"/>
                    <measurement group_id="B2" value="78" lower_limit="70" upper_limit="90"/>
                    <measurement group_id="B3" value="77" lower_limit="65" upper_limit="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Resident Assessment of Ability to Palpate Landmarks</title>
          <description>Operator (resident) assessment of ability to palpate landmarks prior to epidural placement procedure on a scale of 0 extremely difficult to 100 not difficult.</description>
          <population>70 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section and 3 no follow up)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery).</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="70"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="144"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="78" lower_limit="50" upper_limit="93"/>
                    <measurement group_id="B2" value="70" lower_limit="48" upper_limit="87"/>
                    <measurement group_id="B3" value="75" lower_limit="48" upper_limit="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Resident Comfort Performing Procedure (0-10)</title>
          <description>Operator (resident) comfort performing the epidural placement procedure on a scale of 0 (severe discomfort) to 10 being (extremely comfortable).</description>
          <population>70 in the no companion in the room were analysed (1 wd consent and 1 emergency c-section and 3 no follow up)and 74 in the partner in the room group were analysed (1 emergency cesarean delivery).</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="70"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="144"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8" lower_limit="6.5" upper_limit="9"/>
                    <measurement group_id="B2" value="8" lower_limit="7" upper_limit="9"/>
                    <measurement group_id="B3" value="8" lower_limit="6.5" upper_limit="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Maternal Satisfaction and the Presence of a Companion During the Placement of Epidural Catheter for Labor Analgesia.</title>
        <description>The maternal satisfaction after epidural catheter placement for labor analgesia and the presence of a companion scored on a 5 point Likert scale of Highly Dissatisfied, Dissatisfied, Neutral, Satisfied and Highly Satisfied</description>
        <time_frame>Average 12 hours, up to 24 hours after epidural placement</time_frame>
        <group_list>
          <group group_id="O1">
            <title>No Companion Present</title>
            <description>No companion is present during the placement of the epidural catheter.</description>
          </group>
          <group group_id="O2">
            <title>Companion Present</title>
            <description>A companion will be present during the placement of the epidural catheter.&#xD;
Companion Present: A companion will be present during the epidural catheter placement.</description>
          </group>
        </group_list>
        <measure>
          <title>Maternal Satisfaction and the Presence of a Companion During the Placement of Epidural Catheter for Labor Analgesia.</title>
          <description>The maternal satisfaction after epidural catheter placement for labor analgesia and the presence of a companion scored on a 5 point Likert scale of Highly Dissatisfied, Dissatisfied, Neutral, Satisfied and Highly Satisfied</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Highly Dissatisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dissatisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutral</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Satisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Highly Satisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.001</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>.025</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Does the Desire of Subject to Have the Companion Present Affect the Anxiety of the Subject Measured Using the STAI (State-Trait Anxiety Inventory) Questionnaire.</title>
        <description>Analysis of maternal anxiety, pre and post placement of the epidural catheter, using the STAI questionnaire.The STAI is a two part 20 question per part anxiety scale survey. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. The State-Trait Anxiety Inventory (STAI) is used to measure of trait and state anxiety. There are 20 items for assessing trait anxiety and 20 for state anxiety. Both tests are scored on a 4-point scale (from &quot;Almost Never&quot; to &quot;Almost Always&quot;). Score limit for each test is 20 low to 80 high. Low to mild anxiety is a score of 20-37, moderate anxiety is a score of 38-44 and high anxiety is a score of 45-80. The score represents the difference between the pre STAI and the post procedure STAI in each group.</description>
        <time_frame>24 hours after epidural placement</time_frame>
        <group_list>
          <group group_id="O1">
            <title>No Companion Present</title>
            <description>No companion is present during the placement of the epidural catheter.</description>
          </group>
          <group group_id="O2">
            <title>Companion Present</title>
            <description>A companion will be present during the placement of the epidural catheter.&#xD;
Companion Present: A companion will be present during the epidural catheter placement.</description>
          </group>
        </group_list>
        <measure>
          <title>Does the Desire of Subject to Have the Companion Present Affect the Anxiety of the Subject Measured Using the STAI (State-Trait Anxiety Inventory) Questionnaire.</title>
          <description>Analysis of maternal anxiety, pre and post placement of the epidural catheter, using the STAI questionnaire.The STAI is a two part 20 question per part anxiety scale survey. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. The State-Trait Anxiety Inventory (STAI) is used to measure of trait and state anxiety. There are 20 items for assessing trait anxiety and 20 for state anxiety. Both tests are scored on a 4-point scale (from &quot;Almost Never&quot; to &quot;Almost Always&quot;). Score limit for each test is 20 low to 80 high. Low to mild anxiety is a score of 20-37, moderate anxiety is a score of 38-44 and high anxiety is a score of 45-80. The score represents the difference between the pre STAI and the post procedure STAI in each group.</description>
          <units>score on scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7" lower_limit="-13" upper_limit="-1"/>
                    <measurement group_id="O2" value="-11" lower_limit="-17" upper_limit="-3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Does the Presence of a Companion Affect the Perceived Difficulty of the Procedure by the Resident Physician Placing the Labor Epidural Catheter.</title>
        <description>Analysis of the perceived difficulty for the anesthesia resident physician, through utilization of a scale of 0 (severe discomfort to 10 (extremely comfortable).</description>
        <time_frame>After epidural placement</time_frame>
        <group_list>
          <group group_id="O1">
            <title>No Companion Present</title>
            <description>No companion is present during the placement of the epidural catheter.</description>
          </group>
          <group group_id="O2">
            <title>Companion Present</title>
            <description>A companion will be present during the placement of the epidural catheter.&#xD;
Companion Present: A companion will be present during the epidural catheter placement.</description>
          </group>
        </group_list>
        <measure>
          <title>Does the Presence of a Companion Affect the Perceived Difficulty of the Procedure by the Resident Physician Placing the Labor Epidural Catheter.</title>
          <description>Analysis of the perceived difficulty for the anesthesia resident physician, through utilization of a scale of 0 (severe discomfort to 10 (extremely comfortable).</description>
          <units>score on scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8" lower_limit="6.5" upper_limit="9"/>
                    <measurement group_id="O2" value="8" lower_limit="7" upper_limit="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>What is the Preference of Subjects to Have a Companion Present for Future Procedures.</title>
        <description>What is the preference of subjects having a companion present using 5 point Likert like scale of highly unlikely to highly likely.</description>
        <time_frame>24 hours after epidural placement</time_frame>
        <group_list>
          <group group_id="O1">
            <title>No Companion Present</title>
            <description>No companion is present during the placement of the epidural catheter.</description>
          </group>
          <group group_id="O2">
            <title>Companion Present</title>
            <description>A companion will be present during the placement of the epidural catheter.&#xD;
Companion Present: A companion will be present during the epidural catheter placement.</description>
          </group>
        </group_list>
        <measure>
          <title>What is the Preference of Subjects to Have a Companion Present for Future Procedures.</title>
          <description>What is the preference of subjects having a companion present using 5 point Likert like scale of highly unlikely to highly likely.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Highly likely</title>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Likely</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Neutral</title>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unlikely</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Highly unlikely</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Did not respond</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Recommend Care Received Based on Experience of Companion Presence in Room During Epidural Procedure.</title>
        <description>Recommend care based on presence or absence of a companion received based on Likert type scale of highly unlikely to highly likely.</description>
        <time_frame>24 hours after epidural</time_frame>
        <group_list>
          <group group_id="O1">
            <title>No Companion Present</title>
            <description>No companion is present during the placement of the epidural catheter.</description>
          </group>
          <group group_id="O2">
            <title>Companion Present</title>
            <description>A companion will be present during the placement of the epidural catheter.&#xD;
Companion Present: A companion will be present during the epidural catheter placement.</description>
          </group>
        </group_list>
        <measure>
          <title>Recommend Care Received Based on Experience of Companion Presence in Room During Epidural Procedure.</title>
          <description>Recommend care based on presence or absence of a companion received based on Likert type scale of highly unlikely to highly likely.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Highly likely</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LIkely</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutral</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unlikely</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Highly unlikely</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Did not respond</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Sample size of 5 per group to achieve 80% power to detect a change in the log odds ration of 1.0 at a .05 significance level using a two sided Mann Whitney U test.</non_inferiority_desc>
            <p_value>.001</p_value>
            <method>McNemar</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>24 hours after delivery of the baby.</time_frame>
      <desc>Emotional distress answering some of the questionnaires as reported by the subject to the study team members.</desc>
      <group_list>
        <group group_id="E1">
          <title>No Companion</title>
          <description>No companion in the room during the procedure</description>
        </group>
        <group group_id="E2">
          <title>Companion Present</title>
          <description>Companion present during the procedure</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The limitation is our sample was primarily Caucasian with mid to high socioeconomic status. Additionally, most of the companions were married to the study participants.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Feyce Peralta, MD</name_or_title>
      <organization>Northwestern University</organization>
      <phone>312-472-3585</phone>
      <email>feyce.peralta@northwestern.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02982213
org study id: STU00203896
nct id: NCT02982213
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to evaluate if maternal anxiety is improved when a parturient
      gets her choice with regard to the presence of a companion during epidural catheter placement
      for labor analgesia. It will be focused on parturients having their first child with the
      current partner. Additionally, it will investigate the effect of ethnicity, health literacy
      (as evaluated by the Newest Vital Sign questionnaire), catastrophizing (as evaluated by the
      Pain Catastrophizing Scale), and the relationship of the support person to the parturient.
      The investigators hypothesize that there may be specific subgroups in which maternal anxiety
      is improved when a parturient gets her choice regarding the presence of a companion during
      labor epidural catheter placement; however, a significant improvement in maternal anxiety,
      when including all participants, will not be appreciated.
Parturients who have been admitted to the Labor and Delivery ward at Prentice Women's
      Hospital will be approached by a member of the anesthesia team prior to the placement of a
      labor epidural catheter. They will be asked if they are considering neuraxial labor
      analgesia, and if they are they will be screened using the inclusion and exclusion criteria
      to determine study eligibility. Once they have been evaluated and found to be appropriate for
      the study, they will be invited to participate.

      Participants will be asked to fill out the STAI questionnaire to assess the level of anxiety
      prior to placement of the labor epidural catheter, and before knowing their group assignment.
      They will then complete the pre procedure questionnaire. This questionnaire asks about
      expectations she has for the labor epidural procedure. They will then be given the page of
      the Newest Vital Signs questionnaire with the Nutrition Facts, and be asked the 6 questions
      by the recruiter. Then they will be handed the Pain Catastrophizing Scale form with 13
      statements, and asked to fill it out as directed in the instructions at the top. They will
      then be asked who their primary support person is. A form will be handed to that person to
      confidentially record if he/she would prefer to be present for the procedure. This form will
      be collected from the companion, and without the parturient aware of the support person's
      response, she will be asked for her preference with regard to the presence of a companion in
      the room, which will be recorded on this form as well. Finally, she will be asked which
      ethnicity she most relates to, also to be recorded on this form.

      After all these data have been collected, the parturient will be randomized as to whether her
      companion will be allowed in the room or will be asked to leave. This will not be
      communicated to the parturient until the time of the labor epidural catheter placement. When
      she requests the neuraxial labor analgesia, the provider placing the labor epidural catheter
      will be made aware of which group she has been randomized to, and will either ask the
      companion to leave for placement, or provide the support person a non-mobile chair to sit on
      in front of the parturient for placement of the labor epidural. The companion will be asked
      to remain in the chair. He/she will be asked to focus on the parturient. It will be
      emphasized that he/she must remain seated and will not be allowed to observe the procedure
      being performed. This is to prevent loss of consciousness in the support person, which has
      been documented in the literature (Devore and Asrani, 1978; Crosby and Halpern, 1989). One
      violation will result in a warning, and after a second the companion will be escorted out of
      the room and the participant will be removed from the study.

      The provider will place the labor epidural catheter in the regular fashion, as is common
      practice at Prentice Women's Hospital. After preparation and draping of the skin in the
      sitting position, infiltration with Lidocaine 1% will be conducted at L3-L4 or L4-L5. A 17g
      Tuohy needle will be advanced into the epidural space, using a loss of resistance with either
      saline or air, depending on the provider's preference. After the epidural space has been
      located, a 27g pencil-tip spinal needle will be placed through the Tuohy, into the
      intrathecal space, and an intrathecal dose of medication will be administered. The exact dose
      to be injected will be left up to the discretion of the provider, who will determine the
      appropriate dose based on the patient's situation at that time. After the intrathecal dose is
      administered, the spinal needle will be removed and a 19g epidural catheter will be placed
      through the Tuohy into the epidural space. It will be secured at the skin with a sterile
      dressing and tape, leaving 5cm of the catheter in the epidural space. The patient will then
      be placed in a lateral position.

      After the completion of the neuraxial procedure, the study participant will then be asked to
      fill out the STAI questionnaire again. Additionally, she will be asked to record her
      perception of pain during the placement of the labor epidural catheter, using a VAS (Visual
      Analogue Scale) from 0-100mm. At that point the parturient's participation in the study will
      be complete.

      The provider placing the labor epidural catheter will be asked to evaluate his/her ability to
      palpate landmarks for placement, the positioning of the patient, and overall perceived
      difficulty with the epidural placement, using a VAS from 0-100mm for each, which will be kept
      confidential.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maternal Satisfaction and the Presence of a Companion During the Placement of Epidural Catheter for Labor Analgesia.
time frame: Average 12 hours, up to 24 hours after epidural placement
description: The maternal satisfaction after epidural catheter placement for labor analgesia and the presence of a companion scored on a 5 point Likert scale of Highly Dissatisfied, Dissatisfied, Neutral, Satisfied and Highly Satisfied
measure: Does the Desire of Subject to Have the Companion Present Affect the Anxiety of the Subject Measured Using the STAI (State-Trait Anxiety Inventory) Questionnaire.
time frame: 24 hours after epidural placement
description: Analysis of maternal anxiety, pre and post placement of the epidural catheter, using the STAI questionnaire.The STAI is a two part 20 question per part anxiety scale survey. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. The State-Trait Anxiety Inventory (STAI) is used to measure of trait and state anxiety. There are 20 items for assessing trait anxiety and 20 for state anxiety. Both tests are scored on a 4-point scale (from "Almost Never" to "Almost Always"). Score limit for each test is 20 low to 80 high. Low to mild anxiety is a score of 20-37, moderate anxiety is a score of 38-44 and high anxiety is a score of 45-80. The score represents the difference between the pre STAI and the post procedure STAI in each group.
measure: Does the Presence of a Companion Affect the Perceived Difficulty of the Procedure by the Resident Physician Placing the Labor Epidural Catheter.
time frame: After epidural placement
description: Analysis of the perceived difficulty for the anesthesia resident physician, through utilization of a scale of 0 (severe discomfort to 10 (extremely comfortable).
measure: What is the Preference of Subjects to Have a Companion Present for Future Procedures.
time frame: 24 hours after epidural placement
description: What is the preference of subjects having a companion present using 5 point Likert like scale of highly unlikely to highly likely.
measure: Recommend Care Received Based on Experience of Companion Presence in Room During Epidural Procedure.
time frame: 24 hours after epidural
description: Recommend care based on presence or absence of a companion received based on Likert type scale of highly unlikely to highly likely.
arm group label: No companion present
arm group type: No Intervention
description: No companion is present during the placement of the epidural catheter.
arm group label: Companion present
arm group type: Active Comparator
description: A companion will be present during the placement of the epidural catheter.
intervention type: Other
intervention name: Companion Present
description: A companion will be present during the epidural catheter placement.
arm group label: Companion present
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Feyce Peralta, MD
role: Principal Investigator
affiliation: Northwestern University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Feyce M. Peralta, MD, MS
investigator title: Principal Investigator
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The limitation is our sample was primarily Caucasian with mid to high socioeconomic status. Additionally, most of the companions were married to the study participants.
point of contact: 