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NCT Number: NCT07756541

POP SINGER Randomized Clinical Trial

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals

Cleveland, Ohio, 44106, United States

Location status: Recruiting

Location contact

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

PRINCIPAL_INVESTIGATOR

Nita Hoxha, MBA

CONTACT

[email protected]

216-286-6219

Samuel N Rodgers-Melnick, PhD, MPH, LPMT, MT-BC

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Number of participants retained as measured by enrollment logs

    Time frame: 8 weeks from the first music therapy or yoga intervention

    A retention rate of ≥70% of recruited participants until the final survey time point.

  2. Number of sessions attended per participant as measured by attendance logs

    Time frame: 8 weeks from the first music therapy or yoga intervention

    An attendance rate of ≥11/16 sessions among ≥70% of retained participants.

  3. 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

    A measure completion rate of ≥70% of follow-up measures among retained participants.

  4. 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

    ≥60% of retained participants reporting use of music or yoga exercises at least once every other day.

Study contacts

Contact information is provided by the study sponsor or research team.

Nita Hoxha, MBA

CONTACT

[email protected]

216-286-6219

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Collaborators

  • Kulas Foundation

Registry information

Official study title

Pain Management Optimized Through Patient-centered Multi-Session Group Music Therapy Within INteGrative sharEd progRamming: A Feasibility Randomized Controlled Trial

Acronym: POP SINGER RCT

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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