Chronic Pain
Conditions
Keywords
Chronic pain, Music Therapy, Yoga
Brief summary
Conduct a feasibility randomized controlled trial (N = 130, 65 per group) comparing the POPSINGER music therapy (MT) intervention to yoga.
Interventions
BEHAVIORALYoga
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.
BEHAVIORALMusic 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.
Sponsors
University Hospitals Cleveland Medical Center
Kulas Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants retained as measured by enrollment logs | 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 | 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 | 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 | 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. |
Countries
United States
Contacts
CONTACTNita Hoxha, MBA
Outcome results
None listed