Music and Colposcopy in Women With Cervical Dysplasia.

N/ACompletedNCT03005795

Zydolab - Institute of Cytology and Immune Cytochemistry205 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

205

Conditions

Uterine Cervical Dysplasia

Interventions

HeadphonesDEVICE

Music can be heard through headphones

No HeadphonesOTHER

No Headphones will be used.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (2)

Zydolab - Institute of Cytology and Immune Cytochemistry

Dortmund, North Rhine-Westphalia, Germany

Department of Obstetrics and Gynecology of the Ruhr University Bochum

Herne, North Rhine-Westphalia, Germany

Outcomes

Primary Outcomes

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.

Time frame: 10 minutes before and after colposcopy

Secondary Outcomes

Anxiety score after colposcopy

Each women completes the state anxiety questionnaire (state-trait anxiety inventory \[STAI\]) 10 minutes after colposcopy.

Time frame: 10 minutes before and after colposcopy

Change in heart rate

The difference in heart rate before and after colposcopy will be measured.

Time frame: 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').

Time frame: 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').

Time frame: 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").

Time frame: 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")

Data from ClinicalTrials.gov

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