The Effect of Music on Pain in Patients Undergoing Ventral Hernia Repair With Mesh: A Double-Blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 321
- 试验地点
- 2
- 主要终点
- Post operative Pain
研究概览
简要总结
The purpose of this study is to assess whether listening to music during surgery has an effect on pain or anxiety after surgery.
详细描述
After being informed about the study and potential risks and meeting eligibility criteria, all patients giving written informed consent will be scheduled for their hernia repair surgery. On the day of surgery, patients will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to listen to patient-chosen music during their surgery via headphones or just listen to silence via headphones. Pain and anxiety will then be assessed after surgery.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults having open retromuscular ventral hernia repair with mesh, with or without myofascial release for a hernia width ≤ 20 cm
- •Adults having open flank hernia repair that requires a myofascial release with mesh
- •Adults having parastomal hernia repair with mesh
排除标准
- •Primary language other than English, or lack of English language fluency
- •Hearing impairment, with or without use of hearing aids
- •Neurologic condition that, in the opinion of the investigators, may preclude accurate assessment of postoperative pain and anxiety
- •Patients who will remain intubated after surgery
结局指标
主要结局
Post operative Pain
时间窗: At 24 hours (+- 3 hours) after surgery end time.
Pain scores will be assessed using the Numeric Pain Rating Scale (NRS-11); The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
次要结局
- Post operative Anxiety(At 24 hours (+- 3 hours) after surgery end time.)
研究者
Ajita Prabhu, MD
Staff Physician
The Cleveland Clinic