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Behavioral Intervention
Music Therapy for Pancreatic Surgery (MUSIC PUPS Trial)
N/A
Recruiting
Led By Samuel Rodgers-Melnick, MPH, MT-BC
Research Sponsored by University Hospitals Cleveland Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient reports pain intensity of 4/10 or above on day 1 post-surgery
Patient is scheduled to undergo a Whipple procedure or Distal pancreatectomy at UH Cleveland Medical Center with a standardized pain regimen
Must not have
Subject has a significant cognitive impairment that would prevent subject from participating in the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up while the study is active, up to 8 months
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to see if a personalized music relaxation technique, collecting biological samples, and using a mobile device for patient feedback is practical and well-received for adults in the hospital recovering from pancreatic surgery and
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves music therapy, there are no direct physical side effects expected from the intervention itself. However, participants may experience varied emotional responses to the music therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I experienced pain of at least 4 out of 10 the day after surgery.
Select...
I am scheduled for a Whipple procedure or Distal pancreatectomy with a standard pain plan.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any cognitive impairments that would stop me from participating in the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during the enrollment period of the study, up to two months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the enrollment period of the study, up to two months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Biological sample collection
Delivery of a tailored music-assisted relaxation and imagery intervention (MARI)
Patient reported outcome (PRO) data collection
Secondary study objectives
Attrition Rate
Enrollment Rate
Rate of MARI recording use
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Music assisted relaxationExperimental Treatment1 Intervention
Participants will receive a tailored music-assisted relaxation and imagery intervention
Find a Location
Who is running the clinical trial?
University Hospitals Cleveland Medical CenterLead Sponsor
330 Previous Clinical Trials
391,656 Total Patients Enrolled
1 Trials studying Acute Pain
110 Patients Enrolled for Acute Pain
Emory UniversityOTHER
1,708 Previous Clinical Trials
2,607,468 Total Patients Enrolled
Samuel Rodgers-Melnick, MPH, MT-BCPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center
2 Previous Clinical Trials
80 Total Patients Enrolled