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POP SINGER Randomized Clinical Trial (POP SINGER RCT)

2026年8月6日 更新者：Angelique Foss、University Hospitals Cleveland Medical Center

Pain Management Optimized Through Patient-centered Multi-Session Group Music Therapy Within INteGrative sharEd progRamming: A Feasibility Randomized Controlled Trial

Conduct a feasibility randomized controlled trial (N = 130, 65 per group) comparing the POPSINGER music therapy (MT) intervention to yoga.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

130

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • Ohio
      • Cleveland、Ohio、美国、44106
        • 招聘中
        • University Hospitals
        • 接触：
        • 首席研究员：
          • Angelique Foss, CHES®, NBC-HWC, LPMT, MT-BC
        • 副研究员：
          • Samuel N Rodgers-Melnick, PhD, MPH, LPMT, MT-BC

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Adults aged 18 and older
  2. Reporting pain on most days per month for a duration of ≥3 months
  3. Independently ambulatory (i.e., able to walk 10 feet without a cane or walker)
  4. Willing to participate in the full scope of the program
  5. Access to internet, active email address, & laptop, tablet, and/or PC with videoconferencing capabilities
  6. 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
  7. Able to read and understand English

Exclusion Criteria:

  1. Significant hearing and/or visual impairment
  2. Have had a major surgery (e.g., spine surgery, joint replacement) within the past 6 months
  3. Have a planned surgery within the next 6 months at the time of enrollment
  4. Unable to independently provide consent (i.e., no proxy consent)
  5. Active suicidal ideation
  6. Severe psychological comorbidity (e.g., psychosis, schizophrenia) that would prevent patient from engaging fully in intervention
  7. Receiving active cancer treatment.
  8. Diagnosed with medical condition likely to be terminal within 24 weeks
  9. 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
  10. Currently receiving music therapy from a professional music therapist
  11. Currently engaged in regular weekly yoga practice

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：其他
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：音乐疗法
一位拥有董事会认证的音乐治疗师将提供总共16次音乐治疗课程（8次面对面和8次虚拟），包括教育、社交联系和体验式音乐干预。 这些课程将侧重于通过基于证据的音乐治疗干预措施进行疼痛自我管理，包括音乐分享、使用等响度原理的播放列表、音乐制作、音乐与引导想象、音乐与深呼吸、渐进式肌肉放松以及适应性心脏鼓点训练。
行为的：音乐疗法
一位获得委员会认证的音乐治疗师将提供总共16次音乐治疗课程（8次面对面和8次虚拟），包括教育、社交联系和体验式音乐干预。 这些课程将重点通过循证音乐治疗干预措施进行疼痛自我管理，包括音乐分享、运用等值原则的播放列表制作、音乐创作、音乐与引导想象、音乐与深呼吸、渐进式肌肉放松以及适应性心脏鼓击疗法。
实验性的：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.
行为的：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of participants retained as measured by enrollment logs
大体时间：8 weeks from the first music therapy or yoga intervention
A retention rate of ≥70% of recruited participants until the final survey time point.
8 weeks from the first music therapy or yoga intervention
Number of sessions attended per participant as measured by attendance logs
大体时间：8 weeks from the first music therapy or yoga intervention
An attendance rate of ≥11/16 sessions among ≥70% of retained participants.
8 weeks from the first music therapy or yoga intervention
Number of participants completing follow-up measures as measured by data collection logs
大体时间：8 weeks from the first music therapy or yoga intervention
A measure completion rate of ≥70% of follow-up measures among retained participants.
8 weeks from the first music therapy or yoga intervention
Number of participants reporting daily music or yoga exercise use in REDCap exercise logs
大体时间：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.
8 weeks from the first music therapy or yoga intervention

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University Hospitals Cleveland Medical Center

合作者

Kulas Foundation

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月29日

初级完成 (估计的)

2028年8月1日

研究完成 (估计的)

2028年8月1日

研究注册日期

首次提交

2026年8月6日

首先提交符合 QC 标准的

2026年8月6日

首次发布 (实际的)

2026年8月10日

研究记录更新

最后更新发布 (实际的)

2026年8月10日

上次提交的符合 QC 标准的更新

2026年8月6日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • STUDY20260836

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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