Music Listening to Reduce Pain and Anxiety During LEEP

August 29, 2016 updated by: Kittipat Charoenkwan, MD, Chiang Mai University

Effects of Music Listening During Loop Electrosurgical Excision Procedure on Anxiety, Pain, and Satisfaction: a Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Chiang Mai, Thailand, 50200
        • Department of OB-GYN, Faculty of Medicine, Chiang Mai University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Behavioral: Music listening
No Intervention: Control
- Undergoing LEEP according to the usual protocol without listening to music

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Procedure-related pain, as measured by Visual Analog Scale
Time Frame: During the procedure
During the procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Procedure-related anxiety, as measured by Visual Analog Scale
Time Frame: During the procedure
During the procedure
Procedure-related satisfaction, as measured by Visual Analog Scale
Time Frame: During the procedure
During the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiang Mai University

Investigators

  • Principal Investigator: Kittipat Charoenkwan, MD, Faculty of Medicine, Chiang Mai University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

February 27, 2015

First Submitted That Met QC Criteria

March 20, 2015

First Posted (Estimate)

March 26, 2015

Study Record Updates

Last Update Posted (Estimate)

August 30, 2016

Last Update Submitted That Met QC Criteria

August 29, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OBG-2557-02665

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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