<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/NCT02969421</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00078232</org_study_id>
    <nct_id>NCT02969421</nct_id>
  </id_info>
  <brief_title>Pain Perception With Tenaculum Placement</brief_title>
  <official_title>A Randomized Controlled Study of Patient Pain Perception With Tenaculum Placement During In-office Procedures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomized controlled trial that compares methods of tenaculum placement during intrauterine&#xD;
      device insertion and their effect on pain. The two methods being compared are slow tenaculum&#xD;
      placement versus tenaculum placement at time of cough. Subjects will be asked to rate their&#xD;
      pain using visual analog scale. Primary outcome measured is pain at time of tenaculum&#xD;
      placement. Secondary outcomes are overall pain with intrauterine device insertion and&#xD;
      provider satisfaction with tenaculum placement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The two commonly described strategies for tenaculum placement, slow versus having the patient&#xD;
      cough while the tenaculum is placed are utilized by providers based on preference and/or&#xD;
      their previous training. There is no published study that compares these methods to one&#xD;
      another. The investigators aim to compare these strategies, slow tenaculum placement versus&#xD;
      the cough method, and their effects on pain at time of placement. 96 subjects will be&#xD;
      randomized to each method. The subject will be asked to rate their pain using a 100-mm visual&#xD;
      analog scale after speculum placement, after tenaculum is placed, and after completion of the&#xD;
      procedure. The provider will be asked to rate their satisfaction with tenaculum placement on&#xD;
      a Likert-type 5 point satisfaction scale. 1: not at all satisfied, 2: slightly satisfied, 3:&#xD;
      moderately satisfied, 4: very satisfied, 5: extremely satisfied. All data to be collected&#xD;
      using REDCap database.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2016</start_date>
  <completion_date type="Actual">February 23, 2017</completion_date>
  <primary_completion_date type="Actual">February 23, 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>Pain With Tenaculum Placement</measure>
    <time_frame>Directly after tenaculum placement</time_frame>
    <description>Measured using 100-mm visual analog scale. Minimum value 0 meaning no pain and maximum value of 100 meaning worst imaginable pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Pain With Intrauterine Device Insertion</measure>
    <time_frame>Directly after intrauterine device is placed</time_frame>
    <description>Measured using 100-mm visual analog scale. Minimum value 0 meaning no pain and maximum value of 100 meaning worst imaginable pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Provider Satisfaction With Tenaculum Placement</measure>
    <time_frame>Directly after tenaculum is placed</time_frame>
    <description>Measured using Likert-type 5 point satisfaction scale dichotomized to optimal (Likert score = 4 or 5) vs suboptimal (Likert score = 1, 2, 3). Reported is the number of participants with optimal grasp.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Slow Tenaculum Placement</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will have their tenaculum placed using the slow method</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cough Method</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will have their tenaculum placed using the cough method</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cough method for placement of tenaculum</intervention_name>
    <description>The intervention in this arm is the placement of tenaculum via cough method</description>
    <arm_group_label>Cough Method</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Slow Tenaculum Placement of tenaculum</intervention_name>
    <description>The intervention in this arm is the placement of tenaculum via slow method</description>
    <arm_group_label>Slow Tenaculum Placement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women ages 18 years and older&#xD;
&#xD;
          -  Undergoing intrauterine device placement&#xD;
&#xD;
          -  English or Spanish speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Primary language other than English or Spanish&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <results_first_submitted>May 14, 2018</results_first_submitted>
  <results_first_submitted_qc>December 6, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">March 18, 2019</results_first_posted>
  <last_update_submitted>December 6, 2018</last_update_submitted>
  <last_update_submitted_qc>December 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>December 22, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/21/NCT02969421/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Slow Tenaculum Placement</title>
          <description>This group will have their tenaculum placed using the slow method&#xD;
Slow Tenaculum Placement of tenaculum: The intervention in this arm is the placement of tenaculum via slow method</description>
        </group>
        <group group_id="P2">
          <title>Cough Method</title>
          <description>This group will have their tenaculum placed using the cough method&#xD;
Cough method for placement of tenaculum: The intervention in this arm is the placement of tenaculum via cough method</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Slow Tenaculum Placement</title>
          <description>This group will have their tenaculum placed using the slow method&#xD;
Slow Tenaculum Placement of tenaculum: The intervention in this arm is the placement of tenaculum via slow method</description>
        </group>
        <group group_id="B2">
          <title>Cough Method</title>
          <description>This group will have their tenaculum placed using the cough method&#xD;
Cough method for placement of tenaculum: The intervention in this arm is the placement of tenaculum via cough method</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="33"/>
            <count group_id="B2" value="33"/>
            <count group_id="B3" value="66"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25" lower_limit="21" upper_limit="31"/>
                    <measurement group_id="B2" value="28" lower_limit="18" upper_limit="42"/>
                    <measurement group_id="B3" value="26" lower_limit="22.2" upper_limit="31"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="66"/>
                  </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>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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 (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</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>
                  <title>Asian</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>
                  <title>Native Hawaiian or Other Pacific Islander</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>
                  <title>Black or African American</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>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants with Parity &gt;=1</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body mass index</title>
          <units>kg/m^2</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.4" lower_limit="23" upper_limit="36.5"/>
                    <measurement group_id="B2" value="24.8" lower_limit="22" upper_limit="38.1"/>
                    <measurement group_id="B3" value="26.1" lower_limit="22.2" upper_limit="37.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pain With Tenaculum Placement</title>
        <description>Measured using 100-mm visual analog scale. Minimum value 0 meaning no pain and maximum value of 100 meaning worst imaginable pain.</description>
        <time_frame>Directly after tenaculum placement</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Slow Tenaculum Placement</title>
            <description>This group will have their tenaculum placed using the slow method&#xD;
Slow Tenaculum Placement of tenaculum: The intervention in this arm is the placement of tenaculum via slow method</description>
          </group>
          <group group_id="O2">
            <title>Cough Method</title>
            <description>This group will have their tenaculum placed using the cough method&#xD;
Cough method for placement of tenaculum: The intervention in this arm is the placement of tenaculum via cough method</description>
          </group>
        </group_list>
        <measure>
          <title>Pain With Tenaculum Placement</title>
          <description>Measured using 100-mm visual analog scale. Minimum value 0 meaning no pain and maximum value of 100 meaning worst imaginable pain.</description>
          <units>units on a 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="33"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44" lower_limit="21" upper_limit="63"/>
                    <measurement group_id="O2" value="32" lower_limit="19" upper_limit="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Pain With Intrauterine Device Insertion</title>
        <description>Measured using 100-mm visual analog scale. Minimum value 0 meaning no pain and maximum value of 100 meaning worst imaginable pain.</description>
        <time_frame>Directly after intrauterine device is placed</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Slow Tenaculum Placement</title>
            <description>This group will have their tenaculum placed using the slow method&#xD;
Slow Tenaculum Placement of tenaculum: The intervention in this arm is the placement of tenaculum via slow method</description>
          </group>
          <group group_id="O2">
            <title>Cough Method</title>
            <description>This group will have their tenaculum placed using the cough method&#xD;
Cough method for placement of tenaculum: The intervention in this arm is the placement of tenaculum via cough method</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Pain With Intrauterine Device Insertion</title>
          <description>Measured using 100-mm visual analog scale. Minimum value 0 meaning no pain and maximum value of 100 meaning worst imaginable pain.</description>
          <units>units on a 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="33"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62" lower_limit="48" upper_limit="84"/>
                    <measurement group_id="O2" value="54" lower_limit="32" upper_limit="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Provider Satisfaction With Tenaculum Placement</title>
        <description>Measured using Likert-type 5 point satisfaction scale dichotomized to optimal (Likert score = 4 or 5) vs suboptimal (Likert score = 1, 2, 3). Reported is the number of participants with optimal grasp.</description>
        <time_frame>Directly after tenaculum is placed</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Slow Tenaculum Placement</title>
            <description>This group will have their tenaculum placed using the slow method&#xD;
Slow Tenaculum Placement of tenaculum: The intervention in this arm is the placement of tenaculum via slow method</description>
          </group>
          <group group_id="O2">
            <title>Cough Method</title>
            <description>This group will have their tenaculum placed using the cough method&#xD;
Cough method for placement of tenaculum: The intervention in this arm is the placement of tenaculum via cough method</description>
          </group>
        </group_list>
        <measure>
          <title>Provider Satisfaction With Tenaculum Placement</title>
          <description>Measured using Likert-type 5 point satisfaction scale dichotomized to optimal (Likert score = 4 or 5) vs suboptimal (Likert score = 1, 2, 3). Reported is the number of participants with optimal grasp.</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="33"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>10 - 15 minutes of patient contact during and immediately after IUD insertion.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Slow Tenaculum Placement</title>
          <description>This group will have their tenaculum placed using the slow method&#xD;
Slow Tenaculum Placement of tenaculum: The intervention in this arm is the placement of tenaculum via slow method</description>
        </group>
        <group group_id="E2">
          <title>Cough Method</title>
          <description>This group will have their tenaculum placed using the cough method&#xD;
Cough method for placement of tenaculum: The intervention in this arm is the placement of tenaculum via cough method</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="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Non-blinded study&#xD;
No gold standard for pain analysis&#xD;
Lack of accountability for confounder of anxiety/use of anxiolytics</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Tashima Lambert, MD</name_or_title>
      <organization>Duke University Medical Center</organization>
      <phone>484-201-9332</phone>
      <email>dr.tlambert@gmail.com</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/NCT02969421
org study id: Pro00078232
nct id: NCT02969421
lead sponsor: 
has dmc: No
Randomized controlled trial that compares methods of tenaculum placement during intrauterine
      device insertion and their effect on pain. The two methods being compared are slow tenaculum
      placement versus tenaculum placement at time of cough. Subjects will be asked to rate their
      pain using visual analog scale. Primary outcome measured is pain at time of tenaculum
      placement. Secondary outcomes are overall pain with intrauterine device insertion and
      provider satisfaction with tenaculum placement.
The two commonly described strategies for tenaculum placement, slow versus having the patient
      cough while the tenaculum is placed are utilized by providers based on preference and/or
      their previous training. There is no published study that compares these methods to one
      another. The investigators aim to compare these strategies, slow tenaculum placement versus
      the cough method, and their effects on pain at time of placement. 96 subjects will be
      randomized to each method. The subject will be asked to rate their pain using a 100-mm visual
      analog scale after speculum placement, after tenaculum is placed, and after completion of the
      procedure. The provider will be asked to rate their satisfaction with tenaculum placement on
      a Likert-type 5 point satisfaction scale. 1: not at all satisfied, 2: slightly satisfied, 3:
      moderately satisfied, 4: very satisfied, 5: extremely satisfied. All data to be collected
      using REDCap database.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pain With Tenaculum Placement
time frame: Directly after tenaculum placement
description: Measured using 100-mm visual analog scale. Minimum value 0 meaning no pain and maximum value of 100 meaning worst imaginable pain.
measure: Overall Pain With Intrauterine Device Insertion
time frame: Directly after intrauterine device is placed
description: Measured using 100-mm visual analog scale. Minimum value 0 meaning no pain and maximum value of 100 meaning worst imaginable pain.
measure: Provider Satisfaction With Tenaculum Placement
time frame: Directly after tenaculum is placed
description: Measured using Likert-type 5 point satisfaction scale dichotomized to optimal (Likert score = 4 or 5) vs suboptimal (Likert score = 1, 2, 3). Reported is the number of participants with optimal grasp.
arm group label: Slow Tenaculum Placement
arm group type: Active Comparator
description: This group will have their tenaculum placed using the slow method
arm group label: Cough Method
arm group type: Active Comparator
description: This group will have their tenaculum placed using the cough method
intervention type: Other
intervention name: Cough method for placement of tenaculum
description: The intervention in this arm is the placement of tenaculum via cough method
arm group label: Cough Method
intervention type: Other
intervention name: Slow Tenaculum Placement of tenaculum
description: The intervention in this arm is the placement of tenaculum via slow method
arm group label: Slow Tenaculum Placement
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Non-blinded study
No gold standard for pain analysis
Lack of accountability for confounder of anxiety/use of anxiolytics
point of contact: 