The Efficacy of Intraoperative Music Stimulation on Perioperative Pain Management
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Numeric Rating Scale (NRS)
研究概览
简要总结
The goal of this clinical trial is to learn if intraoperative music stimulation works to alleviate perioperative pain in surgical patients undergoing general anesthesia. It will also learn about the possible mechanisms by how music affects pain.
The main questions it aims to answer are:
Does music lower the number of times participants need to use a rescue analgesic? What changes occur in electroencephalogram (EEG) and nociception monitors when participants listen to music? Researchers will compare music to mute or control (hear ambient sounds without earphones) to see if music works to alleviate perioperative pain.
Participants will listen music or mute or ambient sounds throughout the operation, and receive routine anesthesia care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Older than 20 years old and younger than 80 years old
- •male or female
- •Scheduled for minimally invasive surgery (laparoscopic cholecystectomy, appendectomy)
- •Ambulatory surgery
- •American Society of Anesthesiologists (ASA) physical status I~III
排除标准
- •Severe hearing impairment
- •Severe pulmonary or cardiovascular disease
- •Brain or central nervous system (CNS) disorder
- •Long-term systemic steroid or daily morphine treatment
- •Pregnant women
- •Emergency surgery
- •The absence of informed consent
结局指标
主要结局
Numeric Rating Scale (NRS)
时间窗: 1. While in the post-anesthesia care unit, for an average of 1 hour. 2. 24 hours after surgery.
To assess pain severity using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable". Higher scores indicate greater pain intensity.
次要结局
- Analgesic-frequency(1. During the operation. 2. While in the post-anesthesia care unit, for an average of 1 hour. 3. 24 hours after surgery.)
- Analgesic-total amount(1. During the operation. 2. While in the post-anesthesia care unit, for an average of 1 hour. 3. 24 hours after surgery.)
- Post-operative nausea and vomiting (PONV)(1. While in the post-anesthesia care unit, for an average of 1 hour.)
研究者
Sih-hua Chen
Attending Physician, Department of Anesthesiology
Taichung Tzu Chi Hospital