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
研究组 & 干预措施
Yoga
A registered yoga therapist will lead a total of sixteen (16) 60 minute classes over 8 weeks, plus guidance and resources for weekly home practice. Each yoga practice includes postural awareness, breathing practices, physical postures, moving sequences, progressive relaxation, and mental focusing. Philosophical concepts are introduced in each class, including non-harming, gratitude, and self-compassion. Physical practices include standing, seated, and optional floor-based poses that focus on building strength, mobility, and balance. For each practice, a range of options are provided for individuals to select according to their level of physical function and comfort. Props for adapting poses include yoga blocks, straps, blankets, and chairs. Practices are introduced slowly over the 8-week program to ensure safe execution and facilitate self-efficacy.
干预措施: Yoga (Behavioral)
Music Therapy
A board-certified music therapist will provide a total of 16 MT sessions (8 in-person and 8 virtual) that include education, social connection, and experiential music interventions. These sessions will focus on self-management of pain through evidenced-based MT interventions including music sharing, playlists using the iso-principle, music making, music and guided imagery, music and deep breathing, progressive muscle relaxation, and adapted cardio drumming.
干预措施: Music Therapy (Behavioral)
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