Music Listening to Reduce Pain and Anxiety During LEEP

Not Applicable

Completed

• Conditions: Cervical Intraepithelial Neoplasia
• Interventions: Behavioral: Music listening

• Registration Number: NCT02398916
• Lead Sponsor: Chiang Mai University

Brief Summary

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

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-27
• Study First Submitted QC: 2015-03-20
• Study First Posted: 2015-03-26
• Status Verified: 2016-08
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Last Update Submitted: 2016-08-29
• Last Update Posted: 2016-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Music	Music listening	* 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

Primary Outcome Measures

Name	Time	Method
Procedure-related pain, as measured by Visual Analog Scale	During the procedure

Secondary Outcome Measures

Name	Time	Method
Procedure-related anxiety, as measured by Visual Analog Scale	During the procedure
Procedure-related satisfaction, as measured by Visual Analog Scale	During the procedure

Trial Locations

Locations (1)

Department of OB-GYN, Faculty of Medicine, Chiang Mai University; 🇹🇭 Chiang Mai, Thailand