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