Music Listening to Reduce Pain and Anxiety During LEEP

Chiang Mai University

Status: Completed

Conditions: Cervical Intraepithelial Neoplasia

Treatments: Behavioral: Music listening

Study type: Interventional

Funder types: Other

Identifiers

NCT02398916

OBG-2557-02665

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Music

Experimental group

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

Treatment:

Behavioral: Music listening

Control

No Intervention group

Description:

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