The Effects of a Music Therapist Designed Listening Program on Intraoperative Vitrectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- post-operative pain
研究概览
简要总结
This will be a prospective, randomized controlled trial with patients randomly assigned to either the experimental or control group. The experimental group will be exposed to the independent variable (IV) and the control group will not be exposed to the IV. The IV will be a music therapist- designed listening program during surgery. A total of 60 patients will be consecutively enrolled and undergo block randomization to either a music listening group or a control group (no music). Trained medical research personnel will assist with various parts of the study and will be defined as those individuals who have completed and are up-to-date on the Collaborative Institutional Training Initiative (CITI) training. These individuals will consist of a board certified music therapist, practicing ophthalmologists, and physicians-in-training.
详细描述
This prospective trial will block randomize a consecutive cohort of patients undergoing routine vitrectomy surgery at an university hospital to a designed listening program during surgery or to nothing in order to determine whether music listening during surgery can measurably result in decreased patient pain assessed by the Wong-Baker Faces Pain scale. Secondary outcome measures will be blood pressure, need for anxiety medication, postoperative pain medication, and patient overall experience.
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
- Single (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
- •Inclusion criteria will consist of patients already scheduled for elective vitrectomy surgery at a tertiary academic university hospital.
排除标准
- •Exclusion criteria consist of: patients with deafness or unilateral or bilateral severe hearing loss, unwillingness or inability to complete post-surgical surveys, previous vitrectomy surgeries, diagnosed anxiety disorder (claustrophobia, etc.), and/or chronic narcotic or substance abuse.
研究组 & 干预措施
vitrectomy with music listening
Patients undergoing vitrectomy surgery will listen to a designed playlist of music during the entire duration of surgery
干预措施: vitrectomy with music listening (Behavioral)
vitrectomy without music listening
Patients undergoing vitrectomy surgery will not be exposed to music listening.
结局指标
主要结局
post-operative pain
时间窗: during post-operative recovery time, approximately 2 hours
post-operative pain as measured by the Wong-Baker Faces pain scale, 0 is no pain, 10 is the worst pain
次要结局
- pain médication(start to finish of surgery, approximately 1.5 hours)
- anti-anxiety medication(start to finish of surgery, approximately 1.5 hours)
- patient satisfaction(during postoperative recovery time, approximately 2 hours)
- blood pressure(start to finish of surgery, approximately 1.5 hours)
研究者
Stephen J. Kim, MD
Associate Professor
Vanderbilt University Medical Center