NCT02398916已完成不适用
Effects of Music Listening During Loop Electrosurgical Excision Procedure on Anxiety, Pain, and Satisfaction: a Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Procedure-related pain, as measured by Visual Analog Scale
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with confirmed or suspected high-grade intraepithelial neoplasia of the cervix
排除标准
- •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
结局指标
主要结局
Procedure-related pain, as measured by Visual Analog Scale
时间窗: During the procedure
次要结局
- Procedure-related anxiety, as measured by Visual Analog Scale(During the procedure)
- Procedure-related satisfaction, as measured by Visual Analog Scale(During the procedure)
研究者
Kittipat Charoenkwan, MD
Associate Professor
Chiang Mai University
研究点 (2)
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