<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/NCT03030443</url>
  </required_header>
  <id_info>
    <org_study_id>16-275</org_study_id>
    <nct_id>NCT03030443</nct_id>
  </id_info>
  <brief_title>Patient Preferences in Anesthesia for Abortion Care</brief_title>
  <acronym>PAC</acronym>
  <official_title>Patient Preferences in Anesthesia for Abortion Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of New Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Society of Family Planning</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of New Mexico</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will use semi-structured interviews with participants in a prospective cohort&#xD;
      study to explore women's experiences of pain and preferences in pain management during first&#xD;
      trimester surgical abortion to create a more patient centered experience. We will analyze two&#xD;
      study cohorts of women undergoing first trimester surgical abortion: women choosing oral&#xD;
      anesthesia and women choosing nitrous oxide.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will utilize an open-ended semi-structured interview format to elicit a broader&#xD;
      understanding of the multi-dimensional pain experience of woman undergoing an abortion&#xD;
      procedure. This study seeks to provide further evaluation of the pain experience and&#xD;
      preferences of women receiving alternative methods of pain management such as oral sedation&#xD;
      and nitrous oxide.&#xD;
&#xD;
      The study will use semi-structured interviews to explore women's experiences of pain and&#xD;
      preferences in pain management during first trimester surgical abortion and will include a&#xD;
      procedural pain outcome using the visual analog scale (VAS) to create a more patient centered&#xD;
      experience.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 4, 2017</start_date>
  <completion_date type="Actual">February 23, 2022</completion_date>
  <primary_completion_date type="Actual">February 23, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Identify Patient Priorities and Preferences for pain and pain management through Qualitative Analysis</measure>
    <time_frame>through patient completion in study, up to one week following the procedure</time_frame>
    <description>To identify patient priorities and preferences for pain and pain management using Qualitative Analysis prior to their first trimester surgical abortion under local anesthesia with oral or nitrous oxide sedation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compare quantitative and qualitative assessment of pain</measure>
    <time_frame>through patient completion in study, up to one week following the procedure</time_frame>
    <description>Compare the quantitative objective assessment of maximum procedural pain using the visual analog scale (VAS) with the qualitative assessment of pain obtained via semi-structured interviews.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">29</enrollment>
  <condition>Pregnancy Termination in First Trimester</condition>
  <arm_group>
    <arm_group_label>Oral Sedation</arm_group_label>
    <description>Patients in this group will receive a standard procedure first trimester abortion using oral sedation for pain management following the clinic's protocol.&#xD;
Patients in both groups will be administered a Visual Analog Scale (VAS) assessing pain on an unmarked 100mm VAS scale with anchors at 0mm (left) being &quot;no pain&quot; and 100mm (right) being &quot;pain as bad as it could be&quot; before their procedure and immediately following procedure completion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nitrous Oxide</arm_group_label>
    <description>Patients in this group will receive a standard procedure first trimester abortion using titrated nitrous oxide for pain management following the clinic's protocol.&#xD;
Patients in both groups will be administered a Visual Analog Scale (VAS) assessing pain on an unmarked 100mm VAS scale with anchors at 0mm (left) being &quot;no pain&quot; and 100mm (right) being &quot;pain as bad as it could be&quot; before their procedure and immediately following procedure completion.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Women undergoing first trimester surgical abortion choosing between oral anesthesia and&#xD;
        nitrous oxide. All patients will be English-speaking women who are 18 years old or older.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women undergoing first trimester surgical abortion choosing between oral anesthesia or&#xD;
             nitrous oxide for pain management&#xD;
&#xD;
          -  women who are able to read and understand English&#xD;
&#xD;
          -  women who are 18 years old or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  under the age of 18&#xD;
&#xD;
          -  women unable to consent and/or are cognitively impaired&#xD;
&#xD;
          -  women who are incarcerated&#xD;
&#xD;
          -  women who do not speak English&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rameet Singh, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of New Mexico Health Sciences Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of New Mexico</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>May 29, 2023</last_update_submitted>
  <last_update_submitted_qc>May 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of New Mexico</investigator_affiliation>
    <investigator_full_name>Rameet Singh</investigator_full_name>
    <investigator_title>Chief, Division of Family Planning</investigator_title>
  </responsible_party>
  <keyword>Pain management</keyword>
  <keyword>Nitrous</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03030443
org study id: 16-275
nct id: NCT03030443
lead sponsor: 
collaborator: 
has dmc: No
This study will use semi-structured interviews with participants in a prospective cohort
      study to explore women's experiences of pain and preferences in pain management during first
      trimester surgical abortion to create a more patient centered experience. We will analyze two
      study cohorts of women undergoing first trimester surgical abortion: women choosing oral
      anesthesia and women choosing nitrous oxide.
This study will utilize an open-ended semi-structured interview format to elicit a broader
      understanding of the multi-dimensional pain experience of woman undergoing an abortion
      procedure. This study seeks to provide further evaluation of the pain experience and
      preferences of women receiving alternative methods of pain management such as oral sedation
      and nitrous oxide.

      The study will use semi-structured interviews to explore women's experiences of pain and
      preferences in pain management during first trimester surgical abortion and will include a
      procedural pain outcome using the visual analog scale (VAS) to create a more patient centered
      experience.
observational model: Cohort
time perspective: Prospective
measure: Identify Patient Priorities and Preferences for pain and pain management through Qualitative Analysis
time frame: through patient completion in study, up to one week following the procedure
description: To identify patient priorities and preferences for pain and pain management using Qualitative Analysis prior to their first trimester surgical abortion under local anesthesia with oral or nitrous oxide sedation.
measure: Compare quantitative and qualitative assessment of pain
time frame: through patient completion in study, up to one week following the procedure
description: Compare the quantitative objective assessment of maximum procedural pain using the visual analog scale (VAS) with the qualitative assessment of pain obtained via semi-structured interviews.
arm group label: Oral Sedation
description: Patients in this group will receive a standard procedure first trimester abortion using oral sedation for pain management following the clinic's protocol.
Patients in both groups will be administered a Visual Analog Scale (VAS) assessing pain on an unmarked 100mm VAS scale with anchors at 0mm (left) being "no pain" and 100mm (right) being "pain as bad as it could be" before their procedure and immediately following procedure completion.
arm group label: Nitrous Oxide
description: Patients in this group will receive a standard procedure first trimester abortion using titrated nitrous oxide for pain management following the clinic's protocol.
Patients in both groups will be administered a Visual Analog Scale (VAS) assessing pain on an unmarked 100mm VAS scale with anchors at 0mm (left) being "no pain" and 100mm (right) being "pain as bad as it could be" before their procedure and immediately following procedure completion.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Rameet Singh, MD, MPH
role: Principal Investigator
affiliation: University of New Mexico Health Sciences Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of New Mexico
investigator full name: Rameet Singh
investigator title: Chief, Division of Family Planning
sharing ipd: No