Music Therapy for Pancreatic Surgery

(MUSIC PUPS Trial)

Overseen By Jessica Surdam, MPH, CCRC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Hospitals Cleveland Medical Center

Disqualifiers: Visual, hearing, cognitive impairments

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: During hospital stay, up to 2 weeks

5 Participants Needed

Trial Summary

What is the purpose of this trial?

Pilot single arm non-randomized trial to determine the feasibility and acceptability of: 1) a tailored music-assisted relaxation and imagery intervention; 2) biological sample collection; and 3) mobile device patient-reported outcome (MDPRO) collection in adults hospitalized for pancreatic surgery experiencing acute pain.

Research Team

Samuel Rodgers-Melnick, MPH, MT-BC

Principal Investigator

University Hospitals Cleveland Medical Center

Eligibility Criteria

This trial is for English-speaking adults who are scheduled for pancreatic surgery (Whipple procedure or Distal pancreatectomy) at UH Cleveland Medical Center and report post-surgery pain of 4/10 or higher. It's not suitable for those who don't meet the language and pain criteria.

Inclusion Criteria

I experienced pain of at least 4 out of 10 the day after surgery.

Subject is able to speak and understand English

I am scheduled for a Whipple procedure or Distal pancreatectomy with a standard pain plan.

Exclusion Criteria

Subject has a significant hearing impairment that has not been corrected

Subject has a significant visual impairment that has not been corrected

I do not have any cognitive impairments that would stop me from participating in the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 hour

1 visit (in-person)

Treatment

Participants receive a tailored music-assisted relaxation and imagery intervention (MARI) and complete patient-reported outcomes and biological sample collection

During hospital stay, up to 2 weeks

Daily visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment and complete a semi-structured interview

1-2 weeks post-discharge

1 visit (virtual)

Treatment Details

Interventions

• Music Assisted Relaxation Intervention (MARI)

Trial Overview The study tests a tailored music-assisted relaxation and imagery intervention (MARI) to see if it helps with acute pain after pancreatic surgery. It also looks into how well patients accept biological sample collection and using mobile devices to report their outcomes.

Participant Groups

Group I: Music assisted relaxation Experimental Treatment 1 Intervention

Participants will receive a tailored music-assisted relaxation and imagery intervention

Who Is Running the Clinical Trial?

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials

348

Recruited

394,000+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+