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Music Listening to Reduce Pain and Anxiety During LEEP

Primary Purpose

Cervical Intraepithelial Neoplasia

Status

Completed

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

Music listening

About this trial

This is an interventional supportive care trial for Cervical Intraepithelial Neoplasia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Music

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Procedure-related pain, as measured by Visual Analog Scale

Secondary Outcome Measures

Procedure-related anxiety, as measured by Visual Analog Scale

Procedure-related satisfaction, as measured by Visual Analog Scale

Full Information

NCT ID

NCT02398916

First Posted

February 27, 2015

Last Updated

August 29, 2016

Sponsor

Chiang Mai University

1. Study Identification

Unique Protocol Identification Number

NCT02398916

Brief Title

Music Listening to Reduce Pain and Anxiety During LEEP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

February 2015 (undefined)

Primary Completion Date

August 2016 (Actual)

Study Completion Date

August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chiang Mai University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Intraepithelial Neoplasia

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Music

Arm Type

Experimental

Arm Description

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

Arm Title

Control

Arm Type

No Intervention

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Music listening

Primary Outcome Measure Information:

Title

Procedure-related pain, as measured by Visual Analog Scale

Time Frame

During the procedure

Secondary Outcome Measure Information:

Title

Procedure-related anxiety, as measured by Visual Analog Scale

Time Frame

During the procedure

Title

Procedure-related satisfaction, as measured by Visual Analog Scale

Time Frame

During the procedure

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kittipat Charoenkwan, MD

Organizational Affiliation

Faculty of Medicine, Chiang Mai University

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Chiang Mai

ZIP/Postal Code

50200

Country

Thailand

12. IPD Sharing Statement

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Music Listening to Reduce Pain and Anxiety During LEEP

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