Effect of Music on Patient's Anxiety, Satisfaction and Pain During Carotid Endarterectomy: Multicenter Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Differences in intraoperative State-Trait Anxiety Inventory Response (relaxed )
研究概览
简要总结
The purpose of this study is to test the hypothesis that music listening during carotid endarterectomy administered the cervical plexus block will cause less anxiety, less pain, and greater patient satisfaction.
详细描述
Patients who decided to participate in the study were randomized by means of a computer-generated randomization order into 2 groups: Music Group (Group M) and Operating Room (OR) Noise Group (Group O). Randomization was independently carried out in both centers.
Preoperative and postoperative State Trait Anxiety Inventory (STAI) scores, intraoperative STAI responses, preoperative and postoperative numerical rating scale scores for anxiety, pain scores and hemodynamic parameters were recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing carotid endarterectomy using cervical plexus block
- •American Society of Anesthesiologists class 2 to 3
- •Ability to consent
排除标准
- •inability to communicate
- •not understand the aim and objectives of the study
- •not provide informed written consent
- •contraindications for the block (local infection, coagulation disorders)
- •hypersensitivity to the local anesthetics
- •refusal of regional anesthesia
研究组 & 干预措施
music group
in music group, patient was asked to choose one music genres from 5 different music genres according to his/her preference. Patient selected music was delivered by an iPhone 6 and Music app (Apple Inc., USA) through the iPhone's headphones.
干预措施: music (Other)
operating room noise group
in operating room noise group, operating room noise was delivered by an iPhone and Microphone App (Free version, Von Bruno). This application allows the iPhone to be used as a live microphone.
干预措施: operating room noise (Other)
结局指标
主要结局
Differences in intraoperative State-Trait Anxiety Inventory Response (relaxed )
时间窗: 60 minutes
Assessed every 5 minutes during the procedure. The question is "are you relaxed" and patient is asked to answer the question on a scale of "very much, moderately, somewhat, or not at all"
次要结局
- Differences in postoperative State-Trait Anxiety Inventory scores(20 minutes)
- Changes in mean arterial pressure(60 minutes)
- Differences in intraoperative State-Trait Anxiety Inventory Response (calm)(60 minutes)
- Changes in heart rate(60 minutes)
- Differences in postoperative anxiety numerical rating scale scores(10 minutes)
- Differences in preoperative State-Trait Anxiety Inventory scores(20 minutes)
- Differences in pain scores(10 minutes)