POP SINGER Randomized Clinical Trial

NCT07756541 | Recruiting

• 1 other identifier: STUDY20260836
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Pain

Keywords

Chronic pain; Music Therapy; Yoga

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Yoga

EXPERIMENTAL

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

Music Therapy

EXPERIMENTAL

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

Interventions

Yoga BEHAVIORAL

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.

Yoga

Music Therapy BEHAVIORAL

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.

Music Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Kulas Foundation: collaborator

Study Sites (1)

University Hospitals

Cleveland, Ohio, 44106, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Interventions

Yoga; Music Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Sensory Art Therapies; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Nita Hoxha, MBA

CONTACT

216-286-6219; Nita.Hoxha@uhhospitals.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Health Coach

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 10, 2026
• Study Start: July 29, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: August 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)