TRANScriptional Pathways Of Surgical Pain Modulated by Music Therapy Exposure (TRANSPOSE): A Single Arm Pilot Study
| Registry | NCT07653594 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, supportive care |
| Enrollment | 20 (Estimated) |
| Sponsor | Case Comprehensive Cancer Center (Other); collaborators: National Center for Complementary and Integrative Health (NCCIH) |
| Conditions | Surgery, Stomach Cancer, Pancreas Cancer, Bile Duct Cancer, Liver Cancer, Peritoneal Cancer |
| Interventions | Music-assisted relaxation and imagery (MARI) (Behavioral) |
| Dates | start 2027-01-01 (estimated), primary completion 2027-12-01 (estimated), completion 2027-12-01 (estimated), first posted 2026-06-17, last updated 2026-08-05 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Surgery All trials for Stomach Cancer All trials of Music-assisted relaxation and imagery (MARI)
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.
People undergoing surgery for abdominal cancer often experience high levels of pain, stress, and anxiety. Managing these symptoms after surgery is difficult. People often require strong medications for pain relief and may have other comorbidities and anxiety that accompany surgery. Non-pharmacologic approaches, like music therapy (MT) are needed.
Music-assisted relaxation and imagery (MARI) combines live music with guided relaxation, breathing, and imagery. MARI can be personalized to people's preferences. MARI can also be recorded live so that a recording can be given to the participant to use afterward. In a prior study conducted by researchers, people who receiving palliative care reported a decrease in pain after experiencing MARI. In an additional study, MARI was found to more likely result in bigger decreases in pain when compared to traditional MT alone.
Even though there are several studies that support the efficacy of music interventions, like MARI and MT, for addressing pain after surgery, the biological mechanisms are not well understood. Recent advances in functional genomic science provide an opportunity to understand transcriptomic mechanisms. These approaches have been applied to mind-body therapies, recreational music making (RMM), and music listening. However, they have not yet been applied to MT.
A previous study showed that RMM led to a decrease in stress-induced immune response-related genetic markers in a group of healthy volunteers when compared to a control group. In a similar study, adults with cardiovascular disease also showed changes in their genetic markers when exposed to RMM.
However, to date no research has investigated the relationship between gene expression and pain in a medical population experiencing acute post-surgical pain. Given that people undergoing abdominal cancer surgery often experience severe pain, this population is well-suited for investigating the mechanisms by which MT influences acute pain.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Music-assisted relaxation and imagery (MARI) | Experimental | Behavioral: 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). |
Sex: All, ages: 50 Years to 80 Years
Inclusion Criteria: * Age 50 to 80 * Able to speak and understand English * Scheduled to undergo a surgery meeting the following criteria: (1) traditional open surgery (not laparoscopic or robotic) via laparotomy (midline or subcostal incisions), (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 * Participant reports pain intensity of 4/10 or above to study staff on day 1 post-surgery or any other day post-surgery through discharge Exclusion Criteria: * Significant visual impairment that has not been corrected * Significant hearing impairment that has not been corrected * Significant cognitive impairment that would prevent participant from participating in the study
| Facility | City | Country | Status |
|---|---|---|---|
| University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center | Cleveland, Ohio | United States |