The Effect of Perioperative Music Reduces Pain Perception After Anterior Cruciate Ligament Reconstruction.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- visual analog scale
研究概览
简要总结
study the effect of music therapy in pre-operative and post operative period and measure the out come by the visual analog scale (pain score) and analgesic drug use such as morphine and the anxiety score
详细描述
Objectives Primary Objective : To study and compare pain symptoms between the group of patients after undergoing Anterior Cruciate Ligament reconstruction surgery and the control group, using pain relievers along with listening to music perioperatively and postoperatively.
Secondary Objective : To study and compare the levels of anxiety and changes in the circulatory system among patients after undergoing Anterior Cruciate Ligament reconstruction surgery and the control group, from listening to music perioperatively and postoperatively.
Research Questions Does listening to music perioperatively and postoperatively during Arthroscopic Anterior Cruciate Ligament reconstruction surgery help reduce postoperative pain?
Hypothesis The group of patients who listened to music perioperatively and postoperatively during Arthroscopic Anterior Cruciate Ligament reconstruction surgery will experience reduced postoperative pain compared to the group that did not listen to music.
Methodology Randomized Controlled Trial (RCT) Sample Size Calculation The calculation of the sample size for testing two independent means, using the method referenced from the study by Xavier C. Simcock and colleagues on "Intraoperative Music Reduces Perceived Pain After Total Knee Arthroplasty total 38 and add 20% for dropout rate
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis Anterior cruciate ligament tear from MRI
- •Plan to surgery by arthroscopic ACL reconstruction
- •must able to listening music from headphone
排除标准
- •Hearing problem
- •History of morphine and pethidine allergy
- •History of previous knee surgery
- •intraoperative finding multiple ligament injury
研究组 & 干预措施
control
intervention
干预措施: slow beat mesic listening by headphone (Device)
结局指标
主要结局
visual analog scale
时间窗: post op 1,3,12,24,48,72 hours before discharge from hospital
pain score from 0 to 10 (0=no pain, 10=Worst pain)
次要结局
- Amsterdam Preoperative Anxiety and Information Scale(pre-operative and post operative at ward)
- analgesic drug use(post op 1,3,12,24,48,72 hours before discharge from hospital)
研究者
Peerapat Tansakul
Director
Police General Hospital, Thailand