<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/NCT03279666</url>
  </required_header>
  <id_info>
    <org_study_id>2017/47</org_study_id>
    <nct_id>NCT03279666</nct_id>
  </id_info>
  <brief_title>Biopsy Size and Pain Perception During Colposcopic Biopsy</brief_title>
  <official_title>A Randomized Controlled Study: Patients' With or Without Tenaculum Placement and Intracervical Blockage/or Not During Colposcopic Biopsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bakirkoy Dr. Sadi Konuk Research and Training Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bakirkoy Dr. Sadi Konuk Research and Training Hospital</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 investigators will investigate patients pain and biopsy size during colposcopic biopsy.&#xD;
      The investigators will use tenaculum randomized patient with or without intracervical&#xD;
      blockage.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study was designed four arms. The investigators will perform colposcopy because of&#xD;
      various causes. The first arm is used tenaculum and performed intracervical blockage. The&#xD;
      second arm is not used tenaculum and performed intracervical blockage. The third arm is used&#xD;
      tenaculum and not performed intracervical blockage. The fourth arm is not used tenaculum and&#xD;
      not performed intracervical blockage and then we will study patients pain and biopsy size&#xD;
      during colposcopic biopsy. Pain reduce and biopsy size are very important for patient and&#xD;
      diagnose of the cervix cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2017</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">November 30, 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>Crossover Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patients' Biopsy Sizes</measure>
    <time_frame>6 months</time_frame>
    <description>Are patients' biopsy sizes associate with tenaculum. Milimeter will be used for biopsy size.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patients' Biopsy Sizes</measure>
    <time_frame>6 months</time_frame>
    <description>Are patients' biopsy sizes associate with analgesic. Milimeter will be used for biopsy size.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patients' pain perceptions</measure>
    <time_frame>6 months analgesic</time_frame>
    <description>Are patients' pain perceptions associate with analgesic. Linear Visual Analog Scale will be used for pain perception.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients' pain perceptions</measure>
    <time_frame>6 months</time_frame>
    <description>Are patients' pain perceptions associate with teanaculum. Linear Visual Analog Scale will be used for pain perception.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">236</enrollment>
  <condition>Pain Uterus</condition>
  <condition>Tenaculum</condition>
  <arm_group>
    <arm_group_label>tenaculum with intracervical blockage</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>No tenaculum with intracercical blockage</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Tenaculum without intracervical blockage</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>No Tenaculum without intracervical blockage</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Tenaculum replacement</intervention_name>
    <description>Tenaculum replacement during colposcopic biopsy</description>
    <arm_group_label>Tenaculum without intracervical blockage</arm_group_label>
    <arm_group_label>tenaculum with intracervical blockage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-80 year-old women who had colposcopic biopsy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Had orthopedical problems&#xD;
&#xD;
          -  Analgesic allergy&#xD;
&#xD;
          -  Have previous cone biopsy&#xD;
&#xD;
          -  Analgesic use until six hours before colposcopy&#xD;
&#xD;
          -  Advanced cervicovaginal atrophy&#xD;
&#xD;
          -  Linear Visual Analog Score for pain is used&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cihan Comba</name>
      <address>
        <city>İstanbul</city>
        <zip>34000</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>June 7, 2018</last_update_submitted>
  <last_update_submitted_qc>June 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03279666
org study id: 2017/47
nct id: NCT03279666
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators will investigate patients pain and biopsy size during colposcopic biopsy.
      The investigators will use tenaculum randomized patient with or without intracervical
      blockage.
The study was designed four arms. The investigators will perform colposcopy because of
      various causes. The first arm is used tenaculum and performed intracervical blockage. The
      second arm is not used tenaculum and performed intracervical blockage. The third arm is used
      tenaculum and not performed intracervical blockage. The fourth arm is not used tenaculum and
      not performed intracervical blockage and then we will study patients pain and biopsy size
      during colposcopic biopsy. Pain reduce and biopsy size are very important for patient and
      diagnose of the cervix cancer.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Diagnostic
masking: Double (Participant, Investigator)
measure: Patients' Biopsy Sizes
time frame: 6 months
description: Are patients' biopsy sizes associate with tenaculum. Milimeter will be used for biopsy size.
measure: Patients' Biopsy Sizes
time frame: 6 months
description: Are patients' biopsy sizes associate with analgesic. Milimeter will be used for biopsy size.
measure: Patients' pain perceptions
time frame: 6 months analgesic
description: Are patients' pain perceptions associate with analgesic. Linear Visual Analog Scale will be used for pain perception.
measure: Patients' pain perceptions
time frame: 6 months
description: Are patients' pain perceptions associate with teanaculum. Linear Visual Analog Scale will be used for pain perception.
arm group label: tenaculum with intracervical blockage
arm group type: Active Comparator
arm group label: No tenaculum with intracercical blockage
arm group type: No Intervention
arm group label: Tenaculum without intracervical blockage
arm group type: Active Comparator
arm group label: No Tenaculum without intracervical blockage
arm group type: No Intervention
intervention type: Other
intervention name: Tenaculum replacement
description: Tenaculum replacement during colposcopic biopsy
arm group label: Tenaculum without intracervical blockage
arm group label: tenaculum with intracervical blockage
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Sponsor