The Effect of Music Therapy Intervention on Pain and Anxiety in Adult Patients Undergoing Total Shoulder Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 2
- 主要终点
- Change from baseline in pain scores on the visual analog scale at 6 months
研究概览
简要总结
The purpose of this study is to determine if music therapy interventions as adjunct to standard surgical care reduces pre- and post-operative pain and anxiety in patients undergoing total shoulder arthroplasty as compared with patients who receive standard of care without music therapy.
详细描述
This is a prospective, randomized, non-blinded clinical trial. The primary objective is to measure differences in pain and anxiety scores before and after music therapy interventions as compared to patients who do not receive music therapy.
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
- None
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
- •Age greater than or equal to 18 years of age
- •Body mass: 50-125 kg (inclusive )
- •Elective total or reverse total shoulder arthroplasty surgery by the study investigator
- •Gender: male or female (non-pregnant)
- •American Society of Anesthesiologists physical classification scale 1-3
- •Fluent in written and spoken English
- •Patients capable of giving informed consent
排除标准
- •Age less than 18 years of age
- •Non-elective surgery by the study investigator
- •Pregnancy
- •American Society of Anesthesiologists physical classification scale 4-5
- •Non-English speaking persons
- •Diagnosis of cognitive disorder or musicogenic epilepsy
- •Pre-existing hearing problems, defined as inability to independently hear speech or music at average volume
- •Diagnosis of cognitive disorder including psychosis and dementia and/or musicogenic epilepsy
- •Anatomical abnormalities of the shoulder such as cancerous lesions or congenital defects
结局指标
主要结局
Change from baseline in pain scores on the visual analog scale at 6 months
时间窗: 6 months
Patients will be asked to return to the research site a total of six times (pre-operative, pre-surgery, post-surgery, recovery visit (12-24 hours after surgery), two-weeks post-operative visit, and 6 months post-operative visit). Pain scores will be recorded at each of these times.
次要结局
- Change from baseline in anxiety scores on the PROMIS Emotional Distress-Anxiety-Short Form at 6 months(6 months)
研究者
April Armstrong
Principal Investigator / Sponsor
Milton S. Hershey Medical Center