Music and Colposcopy in Women With Cervical Dysplasia.

NCT ID: NCT03005795

Last Updated: 2018-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2018-05-07

Brief Summary

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

Detailed Description

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Conditions

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Uterine Cervical Dysplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Music and colposcopy

Women will hear Mozarts symphony Nr. 40 during the colposcopic examination

Group Type EXPERIMENTAL

Headphones

Intervention Type DEVICE

Music can be heard through headphones

Colposcopy without music

During the colposcopic examination women will not hear music

Group Type ACTIVE_COMPARATOR

No Headphones

Intervention Type OTHER

No Headphones will be used.

Interventions

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Headphones

Music can be heard through headphones

Intervention Type DEVICE

No Headphones

No Headphones will be used.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Zydolab - Institute of Cytology and Immune Cytochemistry

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ziad Hilal, M.D.

Role: PRINCIPAL_INVESTIGATOR

Zydolab - Institute of Cytology and Immune Cytochemistry

Locations

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Zydolab - Institute of Cytology and Immune Cytochemistry

Dortmund, North Rhine-Westphalia, Germany

Site Status

Department of Obstetrics and Gynecology of the Ruhr University Bochum

Herne, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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Hilal Z, Alici F, Tempfer CB, Rath K, Nar K, Rezniczek GA. Mozart for Reducing Patient Anxiety During Colposcopy: A Randomized Controlled Trial. Obstet Gynecol. 2018 Oct;132(4):1047-1055. doi: 10.1097/AOG.0000000000002876.

Reference Type DERIVED
PMID: 30204685 (View on PubMed)

Other Identifiers

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COLPO-3

Identifier Type: -

Identifier Source: org_study_id

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