Music Listening to Reduce Pain and Anxiety During LEEP

NCT ID: NCT02398916

Last Updated: 2016-08-30

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

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-08-31

Brief Summary

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Loop electrosurgical excision procedure (LEEP) is the primary diagnostic and therapeutic procedure employed in women with high-grade intraepithelial neoplasia of the cervix. The procedure usually performed in the outpatient setting under local anesthesia. However, it could be associated with significant pain and anxiety.

The aim of this study is to examine the effects of listening to music during the procedure in reducing pain and anxiety.

Detailed Description

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Conditions

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Cervical Intraepithelial Neoplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Music

* Listening to relaxing music for the entire period starting from waiting period in the surgical waiting area until the end of the LEEP procedure
* Undergoing LEEP according to the usual protocol

Group Type EXPERIMENTAL

Music listening

Intervention Type BEHAVIORAL

Control

\- Undergoing LEEP according to the usual protocol without listening to music

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Music listening

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Women with confirmed or suspected high-grade intraepithelial neoplasia of the cervix

Exclusion Criteria

* Allergy to local anesthetic agent (lidocaine)
* Pregnancy
* Previous major surgical procedures on cervix (conization, LEEP, laser therapy, cryotherapy) or uterus
* Using cardiac pacemaker or history of cardiac arrhythmia
* Neurological disorder affecting perception of pain
* History of lower urinary tract cancer
* Coagulation defects
* History of drug dependence
* Lower genital tract infection
* Apparent invasive cancer of the cervix
* Hearing difficulty
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Chiang Mai University

OTHER

Sponsor Role lead

Responsible Party

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Kittipat Charoenkwan, MD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kittipat Charoenkwan, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Chiang Mai University

Locations

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Department of OB-GYN, Faculty of Medicine, Chiang Mai University

Chiang Mai, Chiang Mai, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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OBG-2557-02665

Identifier Type: -

Identifier Source: org_study_id

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