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Completed

NCT Number: NCT02398916

Music Listening to Reduce Pain and Anxiety During LEEP

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.

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Key information

Conditions

Cervical Intraepithelial Neoplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Neoplasms Precancerous Conditions Urogenital Diseases Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Chiang Mai, 50200, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music listening

Behavioral

Primary outcomes

  1. Procedure-related pain, as measured by Visual Analog Scale

    Time frame: During the procedure

Secondary outcomes

  1. Procedure-related anxiety, as measured by Visual Analog Scale

    Time frame: During the procedure

  2. Procedure-related satisfaction, as measured by Visual Analog Scale

    Time frame: During the procedure

Sponsors and collaborators

Lead sponsor

Chiang Mai University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 26, 2015
Registry last updated
Aug 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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