Cervical Intraepithelial Neoplasia
Conditions
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.
Interventions
BEHAVIORALMusic listening
Sponsors
Chiang Mai University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Procedure-related pain, as measured by Visual Analog Scale | During the procedure |
Secondary
| Measure | Time frame |
|---|---|
| Procedure-related anxiety, as measured by Visual Analog Scale | During the procedure |
| Procedure-related satisfaction, as measured by Visual Analog Scale | During the procedure |
Countries
Thailand
Outcome results
None listed