<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/NCT03005795</url>
  </required_header>
  <id_info>
    <org_study_id>COLPO-3</org_study_id>
    <nct_id>NCT03005795</nct_id>
  </id_info>
  <brief_title>Music and Colposcopy in Women With Cervical Dysplasia.</brief_title>
  <official_title>Does Mozart Reduces Anxiety in Women With Cervical Dysplasia? A Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zydolab - Institute of Cytology and Immune Cytochemistry</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zydolab - Institute of Cytology and Immune Cytochemistry</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>
      To assess the effect of music during colposcopy on women´s anxiety.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">May 7, 2018</completion_date>
  <primary_completion_date type="Actual">May 2, 2018</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in anxiety scores</measure>
    <time_frame>10 minutes before and after colposcopy</time_frame>
    <description>Each women completes the state anxiety questionnaire (state-trait anxiety inventory [STAI]) 10 minutes before and 10 minutes after colposcopy. The difference in scores before and after colposcopy will be measured.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anxiety score after colposcopy</measure>
    <time_frame>10 minutes before and after colposcopy</time_frame>
    <description>Each women completes the state anxiety questionnaire (state-trait anxiety inventory [STAI]) 10 minutes after colposcopy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in heart rate</measure>
    <time_frame>10 minutes</time_frame>
    <description>The difference in heart rate before and after colposcopy will be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain during examination</measure>
    <time_frame>10 minutes</time_frame>
    <description>women scores their pain level using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 (,no pain') to 10 (,worst imaginable pain').</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain after examination</measure>
    <time_frame>10 minutes</time_frame>
    <description>women scores their pain level using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 (,no pain') to 10 (,worst imaginable pain').</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>general unpleasantness during examination</measure>
    <time_frame>10 minutes</time_frame>
    <description>women scores their feeeling during colposcopy using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 (&quot;not at all unpleasant&quot;) to 10 (&quot;extremely unpleasant&quot;).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety during examination</measure>
    <time_frame>10 minutes</time_frame>
    <description>women scores their anxiety during colposcopy using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 (&quot;no anxiety at all&quot;) to 10 (&quot;worst imaginable anxiety&quot;)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Satisfaction</measure>
    <time_frame>10 minutes</time_frame>
    <description>women scores their satisfaction using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 (&quot;maximally unsatisfied&quot;) to 10 (&quot;maximally satisfied&quot;).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">205</enrollment>
  <condition>Uterine Cervical Dysplasia</condition>
  <arm_group>
    <arm_group_label>Music and colposcopy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women will hear Mozarts symphony Nr. 40 during the colposcopic examination</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Colposcopy without music</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>During the colposcopic examination women will not hear music</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Headphones</intervention_name>
    <description>Music can be heard through headphones</description>
    <arm_group_label>Music and colposcopy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Headphones</intervention_name>
    <description>No Headphones will be used.</description>
    <arm_group_label>Colposcopy without music</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women referred for colposcopy due to cervical abnormalities&#xD;
&#xD;
          -  We included women if they attended colposcopy for the first time&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant women&#xD;
&#xD;
          -  presence of a language barrier&#xD;
&#xD;
          -  known anxiety disorder or depression&#xD;
&#xD;
          -  history of conization or other treatments on the cervix uteri&#xD;
&#xD;
          -  known oncological disorder&#xD;
&#xD;
          -  auditory defect&#xD;
&#xD;
          -  cardiovascular disease&#xD;
&#xD;
          -  inadequate colposcopy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ziad Hilal, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zydolab - Institute of Cytology and Immune Cytochemistry</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zydolab - Institute of Cytology and Immune Cytochemistry</name>
      <address>
        <city>Dortmund</city>
        <state>NRW</state>
        <zip>44137</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Obstetrics and Gynecology of the Ruhr University Bochum</name>
      <address>
        <city>Herne</city>
        <state>NRW</state>
        <zip>44625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>December 25, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>May 7, 2018</last_update_submitted>
  <last_update_submitted_qc>May 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cervical dysplasia</keyword>
  <keyword>colposcopy</keyword>
  <keyword>anxiety</keyword>
  <keyword>music</keyword>
  <keyword>mozart</keyword>
  <keyword>randomized controlled trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Dysplasia</mesh_term>
    <mesh_term>Hyperplasia</mesh_term>
  </condition_browse>
  <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/NCT03005795
org study id: COLPO-3
nct id: NCT03005795
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To assess the effect of music during colposcopy on women´s anxiety.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change in anxiety scores
time frame: 10 minutes before and after colposcopy
description: Each women completes the state anxiety questionnaire (state-trait anxiety inventory [STAI]) 10 minutes before and 10 minutes after colposcopy. The difference in scores before and after colposcopy will be measured.
measure: Anxiety score after colposcopy
time frame: 10 minutes before and after colposcopy
description: Each women completes the state anxiety questionnaire (state-trait anxiety inventory [STAI]) 10 minutes after colposcopy.
measure: Change in heart rate
time frame: 10 minutes
description: The difference in heart rate before and after colposcopy will be measured.
measure: Pain during examination
time frame: 10 minutes
description: women scores their pain level using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 (,no pain') to 10 (,worst imaginable pain').
measure: Pain after examination
time frame: 10 minutes
description: women scores their pain level using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 (,no pain') to 10 (,worst imaginable pain').
measure: general unpleasantness during examination
time frame: 10 minutes
description: women scores their feeeling during colposcopy using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 ("not at all unpleasant") to 10 ("extremely unpleasant").
measure: Anxiety during examination
time frame: 10 minutes
description: women scores their anxiety during colposcopy using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 ("no anxiety at all") to 10 ("worst imaginable anxiety")
measure: Overall Satisfaction
time frame: 10 minutes
description: women scores their satisfaction using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 ("maximally unsatisfied") to 10 ("maximally satisfied").
arm group label: Music and colposcopy
arm group type: Experimental
description: Women will hear Mozarts symphony Nr. 40 during the colposcopic examination
arm group label: Colposcopy without music
arm group type: Active Comparator
description: During the colposcopic examination women will not hear music
intervention type: Device
intervention name: Headphones
description: Music can be heard through headphones
arm group label: Music and colposcopy
intervention type: Other
intervention name: No Headphones
description: No Headphones will be used.
arm group label: Colposcopy without music
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ziad Hilal, M.D.
role: Principal Investigator
affiliation: Zydolab - Institute of Cytology and Immune Cytochemistry
facility: 
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Uterine Cervical Dysplasia
mesh term: Hyperplasia
sharing ipd: No