Pain Management Optimized Through Patient-centered Multi-Session Group Music Therapy Within INteGrative sharEd progRamming: A Feasibility Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Number of participants retained as measured by enrollment logs
研究概览
简要总结
Conduct a feasibility randomized controlled trial (N = 130, 65 per group) comparing the POPSINGER music therapy (MT) intervention to yoga.
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
- 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
- •Adults aged 18 and older
- •Reporting pain on most days per month for a duration of ≥3 months
- •Independently ambulatory (i.e., able to walk 10 feet without a cane or walker)
- •Willing to participate in the full scope of the program
- •Access to internet, active email address, & laptop, tablet, and/or PC with videoconferencing capabilities
- •Have reliable access to a mobile device with an active data plan at home and is comfortable accessing the internet and their email with this device
- •Able to read and understand English
排除标准
- •Significant hearing and/or visual impairment
- •Have had a major surgery (e.g., spine surgery, joint replacement) within the past 6 months
- •Have a planned surgery within the next 6 months at the time of enrollment
- •Unable to independently provide consent (i.e., no proxy consent)
- •Active suicidal ideation
- •Severe psychological comorbidity (e.g., psychosis, schizophrenia) that would prevent patient from engaging fully in intervention
- •Receiving active cancer treatment.
- •Diagnosed with medical condition likely to be terminal within 24 weeks
- •Either (a) active substance abuse of cocaine, heroin, cannabis, or alcohol or (b) unmanaged opioid use disorder diagnosis present within the EHR in the last 6 months
- •Currently receiving music therapy from a professional music therapist
- •Currently engaged in regular weekly yoga practice
结局指标
主要结局
Number of participants retained as measured by enrollment logs
时间窗: 8 weeks from the first music therapy or yoga intervention
A retention rate of ≥70% of recruited participants until the final survey time point.
Number of sessions attended per participant as measured by attendance logs
时间窗: 8 weeks from the first music therapy or yoga intervention
An attendance rate of ≥11/16 sessions among ≥70% of retained participants.
Number of participants completing follow-up measures as measured by data collection logs
时间窗: 8 weeks from the first music therapy or yoga intervention
A measure completion rate of ≥70% of follow-up measures among retained participants.
Number of participants reporting daily music or yoga exercise use in REDCap exercise logs
时间窗: 8 weeks from the first music therapy or yoga intervention
≥60% of retained participants reporting use of music or yoga exercises at least once every other day.
次要结局
未报告次要终点
研究者
Angelique Foss
Health Coach
University Hospitals Cleveland Medical Center