Music and Colposcopy in Women With Cervical Dysplasia.

Study Overview
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Brief Summary
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To assess the effect of music during colposcopy on women´s anxiety.

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

Conditions
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Uterine Cervical Dysplasia

Intervention / Treatment
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* Device: Headphones
* Other: No Headphones


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anxiety scores | 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 |
| --- | --- | --- |
| Anxiety score 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 | The difference in heart rate before and after colposcopy will be measured. | 10 minutes | 
| Pain during examination | 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 | 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 | 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 | 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 | women scores their satisfaction using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 (maximally unsatisfied) to 10 (maximally satisfied). | 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical dysplasia, colposcopy, anxiety, music, mozart, randomized controlled trial