Music and Colposcopy in Women With Cervical Dysplasia.

Overview

To assess the effect of music during colposcopy on women´s anxiety.

Full Title of Study: “Does Mozart Reduces Anxiety in Women With Cervical Dysplasia? A Randomized Controlled Trial.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2, 2018

Interventions

  • Device: Headphones
    • Music can be heard through headphones
  • Other: No Headphones
    • No Headphones will be used.

Arms, Groups and Cohorts

  • Experimental: Music and colposcopy
    • Women will hear Mozarts symphony Nr. 40 during the colposcopic examination
  • Active Comparator: Colposcopy without music
    • During the colposcopic examination women will not hear music

Clinical Trial Outcome Measures

Primary Measures

  • Change in anxiety scores
    • Time Frame: 10 minutes before and after colposcopy
    • 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.

Secondary Measures

  • Anxiety score after colposcopy
    • Time Frame: 10 minutes before and after colposcopy
    • Each women completes the state anxiety questionnaire (state-trait anxiety inventory [STAI]) 10 minutes after colposcopy.
  • Change in heart rate
    • Time Frame: 10 minutes
    • The difference in heart rate before and after colposcopy will be measured.
  • Pain during examination
    • Time Frame: 10 minutes
    • women scores their pain level using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 (,no pain’) to 10 (,worst imaginable pain’).
  • Pain after examination
    • Time Frame: 10 minutes
    • women scores their pain level using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 (,no pain’) to 10 (,worst imaginable pain’).
  • general unpleasantness during examination
    • Time Frame: 10 minutes
    • 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”).
  • Anxiety during examination
    • Time Frame: 10 minutes
    • 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”)
  • Overall Satisfaction
    • Time Frame: 10 minutes
    • women scores their satisfaction using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 (“maximally unsatisfied”) to 10 (“maximally satisfied”).

Participating in This Clinical Trial

Inclusion Criteria

  • women referred for colposcopy due to cervical abnormalities – We included women if they attended colposcopy for the first time Exclusion Criteria:

  • pregnant women – presence of a language barrier – known anxiety disorder or depression – history of conization or other treatments on the cervix uteri – known oncological disorder – auditory defect – cardiovascular disease – inadequate colposcopy

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Zydolab – Institute of Cytology and Immune Cytochemistry
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ziad Hilal, M.D., Principal Investigator, Zydolab – Institute of Cytology and Immune Cytochemistry

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