TRANScriptional Pathways Of Surgical Pain Modulated by Music Therapy Exposure (TRANSPOSE)
15. juni 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
20
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Samuel N Rodgers-Melnick, PhD, MPH
- Telefonnummer: 216-844-7727
- E-mail: Samuel.RodgersMelnick@UHhospitals.org
Studiesteder
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Ohio
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Cleveland, Ohio, Forenede Stater, 44106
- University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
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Kontakt:
- Samuel N Rodgers-Melnick, PhD, MPH
- Telefonnummer: 216-844-7727
- E-mail: Samuel.RodgersMelnick@UHhospitals.org
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Ledende efterforsker:
- Samuel N Rodgers-Melnick, PhD, MPH
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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).
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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).
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Proportion of participants whose phlebotomy was collected prior to surgery
Tidsramme: Within 2 weeks prior to surgery
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The feasibility of collecting blood samples prior to surgery is measured by the proportion of participants whose phlebotomy was successfully collected.
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Within 2 weeks prior to surgery
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Proportion of participants whose phlebotomy was collected post-surgery (pre-MARI)
Tidsramme: Post-surgery and prior to MARI intervention (up to 30 days)
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The feasibility of collecting blood samples post-surgery (and pre-MARI intervention) is measured by the proportion of participants whose phlebotomy was successfully collected.
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Post-surgery and prior to MARI intervention (up to 30 days)
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Proportion of participants whose phlebotomy was collected post-MARI
Tidsramme: Post-MARI intervention (up to 30 days)
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The feasibility of collecting blood samples post-MARI is measured by the proportion of participants whose phlebotomy was successfully collected.
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Post-MARI intervention (up to 30 days)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Samuel N Rodgers-Melnick, PhD, MPH, Case Comprehensive Cancer Center, University Hospitals
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. januar 2027
Primær færdiggørelse (Anslået)
1. december 2027
Studieafslutning (Anslået)
1. december 2027
Datoer for studieregistrering
Først indsendt
11. juni 2026
Først indsendt, der opfyldte QC-kriterier
15. juni 2026
Først opslået (Faktiske)
17. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i det endokrine system
- Neoplasmer efter sted
- Neoplasmer
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Sygdomme i fordøjelsessystemet
- Gastrointestinale sygdomme
- Mavesygdomme
- Neoplasmer i endokrine kirtler
- Pancreassygdomme
- Galdevejssygdomme
- Leversygdomme
- Galdevejssygdomme
- Galdevejsneoplasmer
- Neoplasmer i maven
- Bugspytkirtel neoplasmer
- Neoplasmer i leveren
- Galdekanalsneoplasmer
Andre undersøgelses-id-numre
- CASE9226
Plan for individuelle deltagerdata (IPD)
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Kliniske forsøg med Music-assisted relaxation and imagery (MARI)
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University Hospitals Cleveland Medical CenterEmory UniversityAfsluttetAkut smerte | Distal pancreatektomi | Whipple-procedureForenede Stater