Music Listening to Reduce Pain and Anxiety During LEEP

Cervical Intraepithelial Neoplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02398916
• Other study ID #: OBG-2557-02665
• Status: Completed
• Phase: N/A
• First received: February 27, 2015
• Last updated: August 29, 2016
• Start date: February 2015
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Chiang Mai University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia

Intervention

Behavioral:
• Music listening

Locations

Country	Name	City	State
Thailand	Department of OB-GYN, Faculty of Medicine, Chiang Mai University	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedure-related pain, as measured by Visual Analog Scale		During the procedure	No
Secondary	Procedure-related anxiety, as measured by Visual Analog Scale		During the procedure	No
Secondary	Procedure-related satisfaction, as measured by Visual Analog Scale		During the procedure	No