POP SINGER Randomized Clinical Trial (POP SINGER RCT)

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Music Therapy; Behavioral: Yoga

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nita Hoxha, MBA; Phone Number: 216-286-6219; Email: Nita.Hoxha@uhhospitals.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals
      • Contact: Nita Hoxha, MBA; Phone Number: 216-286-6219; Email: Nita.Hoxha@uhhospitals.org
      • Principal Investigator: Angelique Foss, CHES®, NBC-HWC, LPMT, MT-BC
      • Sub-Investigator: Samuel N Rodgers-Melnick, PhD, MPH, LPMT, MT-BC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Experimental: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants retained as measured by enrollment logs	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	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	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	≥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

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Collaborators: Kulas Foundation

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: August 6, 2026
• First Submitted That Met QC Criteria: August 6, 2026
• First Posted (Actual): August 10, 2026

Study Record Updates

• Last Update Posted (Actual): August 10, 2026
• Last Update Submitted That Met QC Criteria: August 6, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Yoga; Chronic pain; Music Therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Therapeutics; Mind-Body Therapies; Complementary Therapies; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Rehabilitation; Aftercare; Continuity of Patient Care; Sensory Art Therapies; Yoga; Music Therapy
• Other Study ID Numbers: STUDY20260836

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No