Music Therapy in Patients Undergoing Pancreatic Surgery (MUSIC PUPS)

NCT06123013 | Completed

• 1 other identifier: STUDY20221489
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Whipple Procedure; Distal Pancreatectomy; Acute Pain

Outcome Measures

Primary Outcomes (3)

• Delivery of a tailored music-assisted relaxation and imagery intervention (MARI)

  Percent of participants that complete the MARI intervention

  Day 1 of the patients post pancreatic surgery hospital stay

• Patient reported outcome (PRO) data collection

  Percent of completed patient reported outcomes surveys

  During the length of patient's hospital stay, up to two weeks

• Biological sample collection

  Percent of of viable biological samples collected

  Day 1 of patient's post pancreatic surgery hospital stay

Secondary Outcomes (3)

• Enrollment Rate

  during the enrollment period of the study, up to two months

• Attrition Rate

  While the study is active, up to 8 months

• Rate of MARI recording use

  during patient's post pancreatic surgery hospital stay, up to two weeks

Study Arms (1)

Music assisted relaxation

EXPERIMENTAL

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

Behavioral: Music Assisted Relation Intervention (MARI)

Interventions

Music Assisted Relation Intervention (MARI) BEHAVIORAL

A standardized 30-minute MARI intervention, personalized to the participant's music and imagery preferences. During the MARI intervention, the board certified music therapist (MT-BC) will provide live guitar accompaniment personalized to the participant's music preferences and read from a standardized script directing the participant to relax muscles of the body, practice deep breaths, and explore a relaxing place.

Music assisted relaxation

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is able to speak and understand English
• Patient is scheduled to undergo a Whipple procedure or Distal pancreatectomy at UH Cleveland Medical Center with a standardized pain regimen
• Patient reports pain intensity of 4/10 or above on day 1 post-surgery

You may not qualify if:

• Subject has a significant visual impairment that has not been corrected
• Subject has a significant hearing impairment that has not been corrected
• Subject has a significant cognitive impairment that would prevent subject from participating in the study

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Emory University: collaborator

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Samuel Rodgers-Melnick, MPH, MT-BC

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 8, 2023
• Study Start: February 1, 2024
• Primary Completion: December 3, 2024
• Study Completion: December 3, 2024
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)