POP SINGER Randomized Clinical Trial

Study Details

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

Study ID

NCT07756541

Start date

Jul 29, 2026

Status verified date

Jul, 2026

Completion date

Aug 1, 2028

Anticipated

Primary completion date

Aug 1, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

Primary outcome measure

Number of participants retained as measured by enrollment logs [ Time Frame: 8 weeks from the first music therapy or yoga intervention ]
Number of sessions attended per participant as measured by attendance logs [ Time Frame: 8 weeks from the first music therapy or yoga intervention ]
Number of participants completing follow-up measures as measured by data collection logs [ Time Frame: 8 weeks from the first music therapy or yoga intervention ]
Number of participants reporting daily music or yoga exercise use in REDCap exercise logs [ Time Frame: 8 weeks from the first music therapy or yoga intervention ]

Central Contacts and Locations

Central contacts

Nita Hoxha, MBA

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

Locations

University Hospitals

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Nita Hoxha, MBA

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

Principal Investigator:

Angelique Foss, CHES®, NBC-HWC, LPMT, MT-BC

POPSINGER & YogaPOP SINGER Randomized Clinical Trial

Study Details

Eligibility Criteria

Study Design

Interventions and Outcome Measures

Central Contacts and Locations

More Information