- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07450131
POP SINGER Pilot Study (POP SINGER 1)
September 1, 2026 updated by: Angelique Foss, University Hospitals Cleveland Medical Center
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
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44106
- University Hospitals
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
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.
|
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
Time Frame: 8 weeks from the first music therapy intervention
|
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
Time Frame: 8 weeks from the first music therapy intervention
|
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
Time Frame: 8 weeks from the first music therapy intervention
|
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
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.
|
8 weeks from the first music therapy intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 13, 2026
Primary Completion (Actual)
July 8, 2026
Study Completion (Actual)
July 8, 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)
September 4, 2026
Last Update Submitted That Met QC Criteria
September 1, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.