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NCT Number: NCT07653594

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

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.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location contact

Samuel N Rodgers-Melnick, PhD, MPH

CONTACT

[email protected]

216-844-7727

Samuel N Rodgers-Melnick, PhD, MPH

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music-assisted relaxation and imagery (MARI)

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Samuel N Rodgers-Melnick, PhD, MPH

CONTACT

[email protected]

216-844-7727

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

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

Important dates

Study start
2027
Primary completion
2027
Study completion
2027
First posted
Jun 17, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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