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
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.
Study Type
Interventional
Primary Outcome
Procedure-related pain, as measured by Visual Analog Scale
Secondary Outcome
Procedure-related anxiety, as measured by Visual Analog Scale
Condition
Cervical Intraepithelial Neoplasia
Intervention
Music listening
Study Arms / Comparison Groups
Music
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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
150
Start Date
February 2015
Completion Date
August 2016
Primary Completion Date
August 2016
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Kittipat Charoenkwan, MD, ,
Location Countries
Thailand
Location Countries
Thailand
Administrative Informations
NCT ID
NCT02398916
Organization ID
OBG-2557-02665
Responsible Party
Principal Investigator
Study Sponsor
Chiang Mai University
Study Sponsor
Kittipat Charoenkwan, MD, Principal Investigator, Faculty of Medicine, Chiang Mai University
Verification Date
August 2016