Acute Pain Clinical Trial
— MUSIC PUPSOfficial title:
Music Therapy in Patients Undergoing Pancreatic Surgery (MUSIC PUPS): A Mixed Methods Feasibility Study
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | June 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 80 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University Hospitals Cleveland Medical Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
University Hospitals Cleveland Medical Center | Emory University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | Biological sample collection | Percent of of viable biological samples collected | Day 1 of patient's post pancreatic surgery hospital stay | |
Secondary | Enrollment Rate | enrolled participants as a percentage of those approached | during the enrollment period of the study, up to two months | |
Secondary | Attrition Rate | percent of patients lost to follow up | While the study is active, up to 8 months | |
Secondary | Rate of MARI recording use | MARI recording use as a percentage of expected usage | during patient's post pancreatic surgery hospital stay, up to two weeks |
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