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

NCT07653594 | Not Yet Recruiting DMC

• 1 other identifier: CASE9226
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgery; Stomach Cancer; Pancreas Cancer; Bile Duct Cancer; Liver Cancer; Peritoneal Cancer

Keywords

Music therapy; Music-assisted relaxation and imagery

Outcome Measures

Primary Outcomes (3)

• Proportion of participants whose phlebotomy was collected 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)

  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

  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)

Study Arms (1)

Music-assisted relaxation and imagery (MARI)

EXPERIMENTAL

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)

Interventions

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).

Also known as: MARI

Music-assisted relaxation and imagery (MARI)

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (13)

• Bhasin MK, Dusek JA, Chang BH, Joseph MG, Denninger JW, Fricchione GL, Benson H, Libermann TA. Relaxation response induces temporal transcriptome changes in energy metabolism, insulin secretion and inflammatory pathways. PLoS One. 2013 May 1;8(5):e62817. doi: 10.1371/journal.pone.0062817. Print 2013.

  PMID: 23650531 BACKGROUND

• Bhasin MK, Denninger JW, Huffman JC, Joseph MG, Niles H, Chad-Friedman E, Goldman R, Buczynski-Kelley B, Mahoney BA, Fricchione GL, Dusek JA, Benson H, Zusman RM, Libermann TA. Specific Transcriptome Changes Associated with Blood Pressure Reduction in Hypertensive Patients After Relaxation Response Training. J Altern Complement Med. 2018 May;24(5):486-504. doi: 10.1089/acm.2017.0053. Epub 2018 Apr 4.

  PMID: 29616846 BACKGROUND

• Dusek JA, Otu HH, Wohlhueter AL, Bhasin M, Zerbini LF, Joseph MG, Benson H, Libermann TA. Genomic counter-stress changes induced by the relaxation response. PLoS One. 2008 Jul 2;3(7):e2576. doi: 10.1371/journal.pone.0002576.

  PMID: 18596974 BACKGROUND

• Bittman B, Berk L, Shannon M, Sharaf M, Westengard J, Guegler KJ, Ruff DW. Recreational music-making modulates the human stress response: a preliminary individualized gene expression strategy. Med Sci Monit. 2005 Feb;11(2):BR31-40.

  PMID: 15668624 BACKGROUND

• Bittman B, Croft DT Jr, Brinker J, van Laar R, Vernalis MN, Ellsworth DL. Recreational Music-Making alters gene expression pathways in patients with coronary heart disease. Med Sci Monit. 2013 Feb 25;19:139-47. doi: 10.12659/MSM.883807.

  PMID: 23435350 BACKGROUND

• Kanduri C, Kuusi T, Ahvenainen M, Philips AK, Lahdesmaki H, Jarvela I. The effect of music performance on the transcriptome of professional musicians. Sci Rep. 2015 Mar 25;5:9506. doi: 10.1038/srep09506.

  PMID: 25806429 BACKGROUND

• Kanduri C, Raijas P, Ahvenainen M, Philips AK, Ukkola-Vuoti L, Lahdesmaki H, Jarvela I. The effect of listening to music on human transcriptome. PeerJ. 2015 Mar 12;3:e830. doi: 10.7717/peerj.830. eCollection 2015.

  PMID: 25789207 BACKGROUND

• Liu Q, Li L, Wei J, Xie Y. Correlation and influencing factors of preoperative anxiety, postoperative pain, and delirium in elderly patients undergoing gastrointestinal cancer surgery. BMC Anesthesiol. 2023 Mar 13;23(1):78. doi: 10.1186/s12871-023-02036-w.

  PMID: 36915054 BACKGROUND

• Ozhanli Y, Akyuz N. The Effect of Progressive Relaxation Exercise on Physiological Parameters, Pain and Anxiety Levels of Patients Undergoing Colorectal Cancer Surgery: A Randomized Controlled Study. J Perianesth Nurs. 2022 Apr;37(2):238-246. doi: 10.1016/j.jopan.2021.08.008. Epub 2021 Dec 10.

  PMID: 34903440 BACKGROUND

• Risser K, Block S, Surdam J, Yu H, Doh SJ, Bretz S, Hoehn RS, Rodgers-Melnick SN. Music Therapy in Patients Undergoing Pancreatic Surgery (MUSIC PUPS): A Mixed Methods Pilot Study. Glob Adv Integr Med Health. 2025 Aug 13;14:27536130251368796. doi: 10.1177/27536130251368796. eCollection 2025 Jan-Dec.

  PMID: 40822036 BACKGROUND

• Rodgers-Melnick SN, Lin L, Gam K, Souza de Santana Carvalho E, Jenerette C, Rowland DY, Little JA, Dusek JA, Bakshi N, Krishnamurti L. Effects of Music Therapy on Quality of Life in Adults with Sickle Cell Disease (MUSIQOLS): A Mixed Methods Feasibility Study. J Pain Res. 2022 Jan 11;15:71-91. doi: 10.2147/JPR.S337390. eCollection 2022.

  PMID: 35046718 BACKGROUND

• Gutgsell KJ, Schluchter M, Margevicius S, DeGolia PA, McLaughlin B, Harris M, Mecklenburg J, Wiencek C. Music therapy reduces pain in palliative care patients: a randomized controlled trial. J Pain Symptom Manage. 2013 May;45(5):822-31. doi: 10.1016/j.jpainsymman.2012.05.008. Epub 2012 Sep 24.

  PMID: 23017609 BACKGROUND

• Rodgers-Melnick SN, Gunzler D, Love TE, Koroukian SM, Beno M, Dusek JA, Rose J. Impact of sociodemographic, clinical, and intervention characteristics on pain intensity within a single music therapy session. J Pain. 2025 Nov;36:105556. doi: 10.1016/j.jpain.2025.105556. Epub 2025 Sep 11.

  PMID: 40945641 BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms; Pancreatic Neoplasms; Bile Duct Neoplasms; Liver Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Biliary Tract Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Liver Diseases

Study Officials

• Samuel N Rodgers-Melnick, PhD, MPH

  Case Comprehensive Cancer Center, University Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samuel N Rodgers-Melnick, PhD, MPH

CONTACT

216-844-7727; Samuel.RodgersMelnick@UHhospitals.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 17, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)