Music and Colposcopy in Women With Cervical Dysplasia.

May 7, 2018 updated by: Zydolab - Institute of Cytology and Immune Cytochemistry

Does Mozart Reduces Anxiety in Women With Cervical Dysplasia? A Randomized Controlled Trial.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

205

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Dortmund, NRW, Germany, 44137
        • Zydolab - Institute of Cytology and Immune Cytochemistry
      • Herne, NRW, Germany, 44625
        • Department of Obstetrics and Gynecology of the Ruhr University Bochum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Music and colposcopy
Women will hear Mozarts symphony Nr. 40 during the colposcopic examination
Device: Headphones
Music can be heard through headphones
Active Comparator: Colposcopy without music
During the colposcopic examination women will not hear music
Other: No Headphones
No Headphones will be used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 minutes before and after colposcopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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').
10 minutes
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').
10 minutes
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").
10 minutes
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")
10 minutes
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").
10 minutes
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.
10 minutes before and after colposcopy
Change in heart rate
Time Frame: 10 minutes
The difference in heart rate before and after colposcopy will be measured.
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zydolab - Institute of Cytology and Immune Cytochemistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Actual)

May 2, 2018

Study Completion (Actual)

May 7, 2018

Study Registration Dates

First Submitted

December 25, 2016

First Submitted That Met QC Criteria

December 28, 2016

First Posted (Estimate)

December 29, 2016

Study Record Updates

Last Update Posted (Actual)

May 8, 2018

Last Update Submitted That Met QC Criteria

May 7, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COLPO-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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