TRANScriptional Pathways Of Surgical Pain Modulated by Music Therapy Exposure (TRANSPOSE)

June 15, 2026 updated by: Case Comprehensive Cancer Center

TRANScriptional Pathways Of Surgical Pain Modulated by Music Therapy Exposure (TRANSPOSE): A Single Arm Pilot Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Samuel N Rodgers-Melnick, PhD, MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
Behavioral: Music-assisted relaxation and imagery (MARI)
Participants 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).
Other Names:
  • MARI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants whose phlebotomy was collected prior to surgery
Time Frame: Within 2 weeks prior to surgery
The feasibility of collecting blood samples prior to surgery is measured by the proportion of participants whose phlebotomy was successfully collected.
Within 2 weeks prior to surgery
Proportion of participants whose phlebotomy was collected post-surgery (pre-MARI)
Time Frame: Post-surgery and prior to MARI intervention (up to 30 days)
The feasibility of collecting blood samples post-surgery (and pre-MARI intervention) is measured by the proportion of participants whose phlebotomy was successfully collected.
Post-surgery and prior to MARI intervention (up to 30 days)
Proportion of participants whose phlebotomy was collected post-MARI
Time Frame: Post-MARI intervention (up to 30 days)
The feasibility of collecting blood samples post-MARI is measured by the proportion of participants whose phlebotomy was successfully collected.
Post-MARI intervention (up to 30 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Comprehensive Cancer Center

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Samuel N Rodgers-Melnick, PhD, MPH, Case Comprehensive Cancer Center, University Hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

June 11, 2026

First Submitted That Met QC Criteria

June 15, 2026

First Posted (Actual)

June 17, 2026

Study Record Updates

Last Update Posted (Actual)

June 17, 2026

Last Update Submitted That Met QC Criteria

June 15, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASE9226

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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