Music Listening to Reduce Pain and Anxiety During LEEP
Effects of Music Listening During Loop Electrosurgical Excision Procedure on Anxiety, Pain, and Satisfaction: a Randomized Controlled Trial
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 27, 2015
CompletedFirst Posted
Study publicly available on registry
March 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedAugust 30, 2016
August 1, 2016
1.5 years
February 27, 2015
August 29, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Procedure-related pain, as measured by Visual Analog Scale
During the procedure
Secondary Outcomes (2)
Procedure-related anxiety, as measured by Visual Analog Scale
During the procedure
Procedure-related satisfaction, as measured by Visual Analog Scale
During the procedure
Study Arms (2)
Music
EXPERIMENTAL* 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
Control
NO INTERVENTION\- Undergoing LEEP according to the usual protocol without listening to music
Interventions
Eligibility Criteria
You may qualify if:
- Women with confirmed or suspected high-grade intraepithelial neoplasia of the cervix
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of OB-GYN, Faculty of Medicine, Chiang Mai University
Chiang Mai, Chiang Mai, 50200, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kittipat Charoenkwan, MD
Faculty of Medicine, Chiang Mai University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 27, 2015
First Posted
March 26, 2015
Study Start
February 1, 2015
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
August 30, 2016
Record last verified: 2016-08