TRANScriptional Pathways Of Surgical Pain Modulated by Music Therapy Exposure (TRANSPOSE)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorCase Comprehensive Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Music-assisted relaxation and imagery (MARI)
BehavioralParticipants 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).
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Music-assisted relaxation and imagery (MARI)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Within 2 weeks prior to surgery2
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.
Time frame
Post-surgery and prior to MARI intervention (up to 30 days)3
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.
Time frame
Post-MARI intervention (up to 30 days)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Case Comprehensive Cancer Center
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: