POP SINGER Pilot Study (POP SINGER 1)

Pain Management Optimized Through Patient-centered Multi-Session Group Music Therapy Within INteGrative sharEd progRamming: A Single-arm Pilot Study

Conduct a single-arm pilot study (N = 24) to examine the feasibility and acceptability of the hybrid (i.e., half in-person, half online) POPSINGER group Music Therapy (MT) intervention.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 24
• 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

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Adults age 18 and older
• Reporting pain on most days per month for a duration of ≥3 months
• Independently ambulatory
• Willing to participate in full scope of 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
• Active substance abuse diagnosis in EHR
• Currently receiving music therapy from a professional music therapist

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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.

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 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 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 intervention
Number of participants reporting daily music exercise use in REDCap exercise logs	≥60% of retained MT participants reporting use of music exercises at least once every other day.	8 weeks from the first music therapy intervention

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Collaborators: Kulas Foundation
• Investigators: Principal Investigator: Angelique Foss, CHES®, NBC-HWC, LPMT, MT-BC, University Hospitals Cleveland Medical Center; Study Director: Samuel N Rodgers-Melnick, PhD, MPH, LPMT, MT-BC, University Hospitals Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: February 26, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Chronic Pain; Virtual; Music Therapy; Group Medical Visits
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Therapeutics; Complementary Therapies; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Rehabilitation; Aftercare; Continuity of Patient Care; Sensory Art Therapies; Music Therapy
• Other Study ID Numbers: STUDY20260037

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