POP SINGER Randomized Clinical Trial
ConditionChronic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospitals Cleveland Medical Center
About this trial
Conduct a feasibility randomized controlled trial (N = 130, 65 per group) comparing the POPSINGER music therapy (MT) intervention to yoga.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Yoga
BehavioralA 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.
Music Therapy
BehavioralA 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.
Treatment groups
130 Participants
are divided into 2 treatment groupsGroup A: YogaExperimental treatment 1 intervention
Group B: Music TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants retained as measured by enrollment logs
A retention rate of ≥70% of recruited participants until the final survey time point.
Time frame
8 weeks from the first music therapy or yoga intervention2
Number of sessions attended per participant as measured by attendance logs
An attendance rate of ≥11/16 sessions among ≥70% of retained participants.
Time frame
8 weeks from the first music therapy or yoga intervention3
Number of participants completing follow-up measures as measured by data collection logs
A measure completion rate of ≥70% of follow-up measures among retained participants.
Time frame
8 weeks from the first music therapy or yoga intervention4
Number of participants reporting daily music or yoga exercise use in REDCap exercise logs
≥60% of retained participants reporting use of music or yoga exercises at least once every other day.
Time frame
8 weeks from the first music therapy or yoga interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospitals Cleveland Medical Center
Lead sponsor
Kulas Foundation
Collaborator
Source ClinicalTrials.gov