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Clinical Trials/NCT07450131
NCT07450131
Recruiting
Not Applicable

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

University Hospitals Cleveland Medical Center1 site in 1 country24 target enrollmentStarted: March 13, 2026Last updated:
InterventionsMusic Therapy

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
24
Locations
1
Primary Endpoint
Number of participants retained as measured by enrollment logs

Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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.

Intervention: Music Therapy (Behavioral)

Outcomes

Primary Outcomes

Number of participants retained as measured by enrollment logs

Time Frame: 8 weeks from the first music therapy intervention

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

Number of sessions attended per participant as measured by attendance logs

Time Frame: 8 weeks from the first music therapy intervention

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

Number of participants completing follow-up measures as measured by data collection logs

Time Frame: 8 weeks from the first music therapy intervention

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

Number of participants reporting daily music exercise use in REDCap exercise logs

Time Frame: 8 weeks from the first music therapy intervention

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Angelique Foss

Health Coach I

University Hospitals Cleveland Medical Center

Study Sites (1)

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