TRANScriptional Pathways Of Surgical Pain Modulated by Music Therapy Exposure (TRANSPOSE)
Part of paid clinical trials in Cleveland, Ohio.
- Sponsor
- Case Comprehensive Cancer Center
- Study ID
- NCT07653594
- Status
- Not Yet Recruiting
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Conditions
- Bile Duct Cancer
- Liver Cancer
- Pancreas Cancer
- Peritoneal Cancer
- Stomach Cancer
- Surgery
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Music-assisted relaxation and imagery (MARI) — BEHAVIORALParticipants will provide their music and imagery preferences, which will be incorporated into the intervention. The intervention will consist of live guitar accompaniment personalized to participants' music preferences and a standardized script directing participants to release tension, take deep breaths, and explore a relaxing place. The MARI intervention will last about 30 minutes. The MARI intervention will be conducted on Day 1 (post-surgery) and a second timepoint determined by participant preference before the participant's hospital discharge (up to Day 30).
Study Details
Participants may take part in this study if they are scheduled to undergo a surgery that meets the following: (1) traditional open surgery via laparotomy, (2) length of surgery \>3 hours, and (3) curative-intent surgical resection of a cancer in the stomach, pancreas, bile ducts, liver, or peritoneal surfaces. The purpose of this study is (1) to evaluate the feasibility of collecting blood samples prior to surgery, post-surgery and pre- music-assisted relaxation and imagery (MARI) intervention, and immediately post-MARI intervention and (2) to identify gene expression changes associated with MARI and explore their relationship with immediate changes in pain intensity. Participants will be in this study for the duration of their hospital admission for surgery.
Key Dates
- Start date
- Jan 31, 2027
- Status verified
- Jun 2026
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Music-assisted relaxation and imagery (MARI)Participants will complete questionnaires to assess pain scores, participate in the MARI intervention, and undergo phlebotomy. Phlebotomy will occur prior to surgery (Day 0) as part of routine labs, post-surgery and pre- and post-MARI intervention (Day 1), and pre- and post-MARI intervention at a second timepoint determined by participant preference (up to Day 30).
Primary Outcome Measure
Proportion of participants whose phlebotomy was collected prior to surgery [ Time Frame: Within 2 weeks prior to surgery ]
Central Contacts
- Samuel N Rodgers-Melnick, PhD, MPH216-844-7727
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106 | Samuel N Rodgers-Melnick, PhD, MPH (PRINCIPAL_INVESTIGATOR) |
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