POP SINGER Pilot Study
ConditionChronic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospitals Cleveland Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Music Therapy
BehavioralA 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.
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: Music TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants retained as measured by enrollment logs
A retention rate of ≥70% of recruited participants until the final survey time point.
Time frame
8 weeks from the first music therapy intervention2
Number of sessions attended per participant as measured by attendance logs
An attendance rate of ≥11/16 sessions among ≥70% of retained participants.
Time frame
8 weeks from the first music therapy intervention3
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.
Time frame
8 weeks from the first music therapy intervention4
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.
Time frame
8 weeks from the first music therapy interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospitals Cleveland Medical Center
Lead sponsor
Kulas Foundation
Collaborator
Source ClinicalTrials.gov