Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

3 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

20

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • Ohio
      • Cleveland, Ohio, Verenigde Staten, 44106
        • University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
        • Contact:
        • Hoofdonderzoeker:
          • Samuel N Rodgers-Melnick, PhD, MPH

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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).
Gedragsmatig: 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).
Andere namen:
  • MARI

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of participants whose phlebotomy was collected prior to surgery
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Case Comprehensive Cancer Center

Medewerkers

National Center for Complementary and Integrative Health (NCCIH)

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 januari 2027

Primaire voltooiing (Geschat)

1 december 2027

Studie voltooiing (Geschat)

1 december 2027

Studieregistratiedata

Eerst ingediend

11 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

15 juni 2026

Eerst geplaatst (Werkelijk)

17 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

3 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CASE9226

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren