<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/NCT04420208</url>
  </required_header>
  <id_info>
    <org_study_id>202004014RINB</org_study_id>
    <nct_id>NCT04420208</nct_id>
  </id_info>
  <brief_title>Ameliorating the Obstacle of Pap Smear</brief_title>
  <official_title>Ameliorating the Obstacle of Pap Smear: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      To reduce the procedural pain of Pap smear, this study expects to apply the peak-end rule to&#xD;
      Pap smear by prolonging the insertion of speculum after samples are obtained from the cervix.&#xD;
      This study aims to conduct a randomized controlled study at a tertiary center, National&#xD;
      Taiwan University Hospital (NTUH). The investigators expect to compare the recalled pain&#xD;
      intensity of the intervention and control groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose: In order to reduce the procedural pain, this study expects to apply the peak-end&#xD;
      rule to Pap smear by prolonging the insertion of speculum after samples are obtained from the&#xD;
      cervix. Methods: This study aims to conduct a randomized controlled study at NTUH.&#xD;
      Approximately 200 subjects are expected to be recruited. The investigators will utilize the&#xD;
      peak-end rule by adding a non-painful step right after the most uncomfortable phase in the&#xD;
      intervention group. All study subjects are requested to score on a numeric pain scale during&#xD;
      the Pap test. All operators experienced in techniques for performing a Pap test should attend&#xD;
      workshops for a standard operating procedure. A well-trained research assistant is also&#xD;
      responsible for ensuring standardization of procedures to eliminate interoperator&#xD;
      variability. The primary outcome was the recalled pain intensity at five minutes after the&#xD;
      Pap smear test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 28, 2020</start_date>
  <completion_date type="Actual">October 11, 2021</completion_date>
  <primary_completion_date type="Actual">October 31, 2020</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>
    <intervention_model_description>Subjects are divided into two groups, one with traditional Pap smear and one with Pap smear adding a non-painful procedure at the end. The investigators will compare the real-time pain score and recalled pain to check whether the theory works.</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>During the Pap test, there is a privacy curtain separating participants from the operators. Participants receiving the modified Pap test do not realize what is going on during the 15-second step because they are behind the privacy curtain. The operators performing the procedure are not informed whether to intervene or not by the assistants until a specimen is prepared for cervical cytology. The delayed disclosure of the group allocation until this step ensures the operators standardizing the insertion and opening phases of the Pap test.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Recalled pain just after the Pap smear test using a 1-5 numeric scale</measure>
    <time_frame>Five minutes after the Pap test</time_frame>
    <description>This recalled pain intensity is evaluated with a 1-5 numeric scale (1:no pain; 5: maximal pain).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Recalled pain just after the Pap smear test using a a 0-10 visual analog scale</measure>
    <time_frame>Five minutes after the Pap test</time_frame>
    <description>This recalled pain intensity is evaluated with a 0-10 visual analog scale (0: no pain; 10: maximal pain), where pain was categorized as mild, moderate, and severe.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Real-time pain during the Pap test using a 1-5 numeric scale</measure>
    <time_frame>Every five seconds throughout the Pap test</time_frame>
    <description>The participants are asked to evaluate and record their pain every five seconds throughout the test. The real-time pain is recorded with a 1 to 5 numeric scale (1:no pain; 5: maximal) at the beginning, the first quarter, the second quarter, the third quarter, and the end of the regular course in all participants; as well as right after the additional 15-second step in the group receiving modified Pap tests. The average pain, the maximal pain, as well as real-time pain at the beginning, the first quarter, the second quarter, the third quarter, and the end of the regular course are compared between the two groups. For each group, we also compare the average pain of the first half and the second half of the total course. For participants receiving the modified Pap test, we further compare the average pain, the maximal pain, and the last recorded real-time pain of the 15-second step with that of the regular course.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long-term recalled pain after the Pap test using a 1-5 numeric scale</measure>
    <time_frame>One year after the Pap test</time_frame>
    <description>Evaluated with a 1-5 numeric scale (1: no pain; 5: maximal pain).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long-term recalled pain after the Pap test using a 0-10 visual analog scale</measure>
    <time_frame>One year after the Pap test</time_frame>
    <description>Evaluated with a 0-10 visual analog scale (0: no pain; 10: maximal pain).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Willingness to receive further Pap tests</measure>
    <time_frame>One year after the Pap test</time_frame>
    <description>0-10 grades (0: unwillingness; 10: highest grade of willingness)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">268</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Modified Pap test</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adding a non-painful event after the most uncomfortable phase of Pap smear.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional Pap test</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Traditional Pap-smear procedure as control.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Modified Pap test</intervention_name>
    <description>Adding a non-painful step after the most uncomfortable phase of Pap smear</description>
    <arm_group_label>Modified Pap test</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Biological female&#xD;
&#xD;
          -  Aged 30-70&#xD;
&#xD;
          -  Provision of written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Active vaginal or uterus infection&#xD;
&#xD;
          -  Incapable of understanding the numeric pain scales&#xD;
&#xD;
          -  Prior cervical cancer diagnosis&#xD;
&#xD;
          -  Prior hysterectomy, pelvic or vaginal surgery&#xD;
&#xD;
          -  Ongoing menstruation&#xD;
&#xD;
          -  Use of painkillers within 24 hours&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chien-Hsieh Chiang, MD, MPH</last_name>
    <role>Study Chair</role>
    <affiliation>Attending physician</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Taiwan University Hosputal</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>October 27, 2021</last_update_submitted>
  <last_update_submitted_qc>October 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cervical cancer screening</keyword>
  <keyword>Pap smear</keyword>
  <keyword>Procedural pain</keyword>
  <keyword>Peak-end rule</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/NCT04420208
org study id: 202004014RINB
nct id: NCT04420208
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To reduce the procedural pain of Pap smear, this study expects to apply the peak-end rule to
      Pap smear by prolonging the insertion of speculum after samples are obtained from the cervix.
      This study aims to conduct a randomized controlled study at a tertiary center, National
      Taiwan University Hospital (NTUH). The investigators expect to compare the recalled pain
      intensity of the intervention and control groups.
Purpose: In order to reduce the procedural pain, this study expects to apply the peak-end
      rule to Pap smear by prolonging the insertion of speculum after samples are obtained from the
      cervix. Methods: This study aims to conduct a randomized controlled study at NTUH.
      Approximately 200 subjects are expected to be recruited. The investigators will utilize the
      peak-end rule by adding a non-painful step right after the most uncomfortable phase in the
      intervention group. All study subjects are requested to score on a numeric pain scale during
      the Pap test. All operators experienced in techniques for performing a Pap test should attend
      workshops for a standard operating procedure. A well-trained research assistant is also
      responsible for ensuring standardization of procedures to eliminate interoperator
      variability. The primary outcome was the recalled pain intensity at five minutes after the
      Pap smear test.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Subjects are divided into two groups, one with traditional Pap smear and one with Pap smear adding a non-painful procedure at the end. The investigators will compare the real-time pain score and recalled pain to check whether the theory works.
primary purpose: Screening
masking: Single (Participant)
masking description: During the Pap test, there is a privacy curtain separating participants from the operators. Participants receiving the modified Pap test do not realize what is going on during the 15-second step because they are behind the privacy curtain. The operators performing the procedure are not informed whether to intervene or not by the assistants until a specimen is prepared for cervical cytology. The delayed disclosure of the group allocation until this step ensures the operators standardizing the insertion and opening phases of the Pap test.
measure: Recalled pain just after the Pap smear test using a 1-5 numeric scale
time frame: Five minutes after the Pap test
description: This recalled pain intensity is evaluated with a 1-5 numeric scale (1:no pain; 5: maximal pain).
measure: Recalled pain just after the Pap smear test using a a 0-10 visual analog scale
time frame: Five minutes after the Pap test
description: This recalled pain intensity is evaluated with a 0-10 visual analog scale (0: no pain; 10: maximal pain), where pain was categorized as mild, moderate, and severe.
measure: Real-time pain during the Pap test using a 1-5 numeric scale
time frame: Every five seconds throughout the Pap test
description: The participants are asked to evaluate and record their pain every five seconds throughout the test. The real-time pain is recorded with a 1 to 5 numeric scale (1:no pain; 5: maximal) at the beginning, the first quarter, the second quarter, the third quarter, and the end of the regular course in all participants; as well as right after the additional 15-second step in the group receiving modified Pap tests. The average pain, the maximal pain, as well as real-time pain at the beginning, the first quarter, the second quarter, the third quarter, and the end of the regular course are compared between the two groups. For each group, we also compare the average pain of the first half and the second half of the total course. For participants receiving the modified Pap test, we further compare the average pain, the maximal pain, and the last recorded real-time pain of the 15-second step with that of the regular course.
measure: Long-term recalled pain after the Pap test using a 1-5 numeric scale
time frame: One year after the Pap test
description: Evaluated with a 1-5 numeric scale (1: no pain; 5: maximal pain).
measure: Long-term recalled pain after the Pap test using a 0-10 visual analog scale
time frame: One year after the Pap test
description: Evaluated with a 0-10 visual analog scale (0: no pain; 10: maximal pain).
measure: Willingness to receive further Pap tests
time frame: One year after the Pap test
description: 0-10 grades (0: unwillingness; 10: highest grade of willingness)
arm group label: Modified Pap test
arm group type: Experimental
description: Adding a non-painful event after the most uncomfortable phase of Pap smear.
arm group label: Traditional Pap test
arm group type: No Intervention
description: Traditional Pap-smear procedure as control.
intervention type: Procedure
intervention name: Modified Pap test
description: Adding a non-painful step after the most uncomfortable phase of Pap smear
arm group label: Modified Pap test
criteria: 
gender: Female
minimum age: 30 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Chien-Hsieh Chiang, MD, MPH
role: Study Chair
affiliation: Attending physician
facility: 
country: Taiwan
responsible party type: Sponsor
sharing ipd: No