Whipple ProcedureMUSIC PUPSNCT06123013
Music Therapy in Patients Undergoing Pancreatic Surgery (MUSIC PUPS)
A study testing Music Assisted Relation Intervention (MARI) in people with Whipple Procedure and Distal Pancreatectomy, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
Pilot single arm non-randomized trial to determine the feasibility and acceptability of: 1) a tailored music-assisted relaxation and imagery intervention; 2) biological sample collection; and 3) mobile device patient-reported outcome (MDPRO) collection in adults hospitalized for pancreatic surgery experiencing acute… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Whipple Procedure, Distal Pancreatectomy, Acute Pain
- What is being tested?
- Music Assisted Relation Intervention (MARI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2024to 3 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is able to speak and understand English
- Patient is scheduled to undergo a Whipple procedure or Distal pancreatectomy at UH Cleveland Medical Center with a standardized pain regimen
- Patient reports pain intensity of 4/10 or above on day 1 post-surgery
Who cannot join
- Subject has a significant visual impairment that has not been corrected
- Subject has a significant hearing impairment that has not been corrected
- Subject has a significant cognitive impairment that would prevent subject from participating in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
About this study
Official title: Music Therapy in Patients Undergoing Pancreatic Surgery (MUSIC PUPS): A Mixed Methods Feasibility Study
Pilot single arm non-randomized trial to determine the feasibility and acceptability of: 1) a tailored music-assisted relaxation and imagery intervention; 2) biological sample collection; and 3) mobile device patient-reported outcome (MDPRO) collection in adults hospitalized for pancreatic surgery experiencing acute pain.
Read the detailed description
After the participant's pancreatic surgery and during their post-surgery hospitalization, the RA will confirm participant eligibility and continued willingness to participate. About an hour later, the RA will return to the participant's room. Before collecting any data, the RA will ask the participant if their pain will permit them to continue and if they would like to proceed. If the participant responds affirmatively, the RA will document this in REDCap and then will proceed to collect baseline (Time 0) patient-reported outcomes (PROs) (i.e., 0-10 ratings of pain, stress, and anxiety) using a REDCap instrument administered on an iPad. The RA will not view the participant's PRO responses. If the participant is currently utilizing a patient-controlled analgesia (PCA) pump, the RA will collect measures of medication usage from the PCA pump. The RA will also collect a peripheral blood sample using a Spot On Sciences HemaSpot-HF. The research team chose the HemaSpot HF because it is an efficient and less invasive means of collecting capillary blood. Using the HemaSpot HF also poses less risk and discomfort to these patients who recently underwent major surgery. Following baseline measure collection, the RA will leave the participant's room.
Following Time 0, the MT-BC will deliver a standardized 30-minute MARI intervention, personalized to the participant's music and imagery preferences. Prior to the intervention, the MT-BC will verify the participant's music and imagery preferences discussed with the RA earlier in the day. During the MARI intervention, the MT-BC will provide live guitar accompaniment personalized to the participant's music preferences and read from a standardized script directing the participant to relax muscles of the body, practice deep breaths, and explore a relaxing place. This intervention will be recorded live and exported to either a study iOS device (e.g., iPod touch, iPhone) programmed to track MARI recording use or uploaded to a Box folder that will be shared with the participant to listen to on their own device. Following the MARI intervention, the MT-BC will briefly process the participant's experience by asking them how the experience was for them and to describe in their own words how they are feeling after the MARI intervention. (please see the attachment "MUSIC PUPS Post MARI Debriefing" for more details). The RA will export the MARI recording to a Box folder that the participant can access using the iOS device.
Immediately following the MARI intervention and post-intervention processing, the MT-BC will leave the participant's room. The RA will then enter the participant's room again. The RA will confirm that the participant is not in too much pain to continue and would like to continue with study procedures, documenting this in REDCap, before collecting post-intervention PROs and peripheral blood smear measures (Time 1). After collecting these measures, the RA will wait in the participant's room for 15 minutes. At 15-minutes post-intervention (Time 2), the RA will again collect PROs and a final peripheral blood smear measure.
Then, the RA will show the participant how to access the MARI recording and enter MDPRO measurements using either the study iOS device or their own device. The RA will instruct the participant to listen to the MARI intervention 3x/day and complete 3 MDPRO measurements each day until discharge. The iOS device will be locked to the participant's tray table to prevent it from being lost or stolen during the participant's hospitalization.
Following the collection of blood samples and PROs, the RA will conduct a review of the participant's medical record to collect data on the participant's demographics, clinical characteristics, and pain medications administered pre-intervention. The RA will enter this data into REDCap. Following sample collection, blood samples will be temporarily stored within the Connor Whole Health research office. Samples will then be shipped within 12 hours to Manoj Bhasin's lab at Emory University for storage and subsequent analysis.
The RA will meet with each participant every day, Monday through Friday, until discharge to troubleshoot any barriers to MARI use or MDPRO collection. Each day, before any troubleshooting or collecting any data, the RA , like on day one, will (1) check in with the treating physician and/or the clinical nurse; (2) ask the participant if their pain level will permit them to participate; and (3) ask the participant if they still want to participate in study procedures. If the participant responds affirmatively to continuing study procedures, the RA will document this in REDCap and then proceed with troubleshooting and data collection. The RA will record any barriers to MARI use and/or MDPRO collection (i.e., forgot, technical difficulties, off the floor for a procedure) as well as the participant's self-reported use of MARI in the last 24 hours. From Day 2 (i.e., the day after the live MARI intervention) until the participant is discharged from the hospital, the participant will receive three notifications per day (i.e., morning, afternoon, and evening) on the iOS device to complete MDPRO measures. The participant's use of the MARI recording will be tracked using file utilization measures available within Box.com. No PHI will be entered into the Box.com folder. The RA will also track the participant's use of pain medications (recorded in the EHR or on the PCA). All data will be stored in REDCap.
On the day of the participant's discharge from the hospital, the RA will collect the study iOS device, if applicable. The RA will provide the participant with the MARI recording via email and a Box.com link to allow the participant to access the recording post-discharge. If desired, the RA will also provide the recording via a compact disk. Following discharge, the study coordinator will arrange a time for the participant to complete a semi-structured interview over Zoom. One to two weeks after the participant's discharge from the hospital, researchers will meet with the participant over a HIPAA-compliant commercial tele-health platform to complete a semi-structured interview. If the participant is expected to be discharged over the weekend, the RA will provide the MARI recording resources on the Friday before the weekend in which the participant is to be discharged.
Interview procedures Interviews will take place over a HIPAA-compliant commercial tele-health platform (i.e., Zoom for Healthcare) or over the phone one-to-two weeks after the participant is discharged from the hospital. During that interview, a researcher will ask the participant about their experience in the study and what they thought about the MARI intervention. The researcher conducting the interviews remotely will be in a private room when interviewing the participants and will be certified in human subject protection and GCP, researched credentialed if applicable, and on the study personnel table. The interview will take about 20 minutes and will be recorded and then transcribed by hand.
- Conditions
- Whipple Procedure, Distal Pancreatectomy, Acute Pain
- Being tested
- Music Assisted Relation Intervention (MARI)
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music Assisted Relation Intervention (MARI)Behavioural
A standardized 30-minute MARI intervention, personalized to the participant's music and imagery preferences. During the MARI intervention, the board certified music therapist (MT-BC) will provide live guitar accompaniment personalized to the participant's music preferences and read from a standardized script directing the participant to relax muscles of the body, practice deep breaths, and explore a relaxing place.
| Study group | Role | What they receive |
|---|---|---|
| Music assisted relaxation | Experimental | Participants will receive a tailored music-assisted relaxation and imagery intervention Receives: Behavioral: Music Assisted Relation Intervention (MARI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delivery of a tailored music-assisted relaxation and imagery intervention (MARI)
Percent of participants that complete the MARI intervention
Measured: Day 1 of the patients post pancreatic surgery hospital stay
Patient reported outcome (PRO) data collection
Percent of completed patient reported outcomes surveys
Measured: During the length of patient's hospital stay, up to two weeks
Biological sample collection
Percent of of viable biological samples collected
Measured: Day 1 of patient's post pancreatic surgery hospital stay
Secondary outcomes (3)
Enrollment Rate
enrolled participants as a percentage of those approached
Measured: during the enrollment period of the study, up to two months
Attrition Rate
percent of patients lost to follow up
Measured: While the study is active, up to 8 months
Rate of MARI recording use
MARI recording use as a percentage of expected usage
Measured: during patient's post pancreatic surgery hospital stay, up to two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start1 Feb 2024
- Primary completion3 Dec 2024
- Study completion3 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Whipple ProcedureStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University
- Responsible party
- Principal investigator, Samuel Rodgers-Melnick, University Hospitals Cleveland Medical Center
- Investigators
- Samuel Rodgers-Melnick, MPH, MT-BC, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123013
- Sponsor's protocol ID
- STUDY20221489
- Acronym
- MUSIC PUPS
- Status last verified
- Mar 2025
- First submitted
- 2 Nov 2023
- Last updated
- 27 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Therapy in Patients Undergoing Pancreatic Surgery (MUSIC PUPS): A Mixed Methods Feasibility Study
- ClinicalTrials.gov ID
- NCT06123013
- Acronym / sponsor ID
- MUSIC PUPS / STUDY20221489
- Conditions
- Whipple Procedure, Distal Pancreatectomy, Acute Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Emory University
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 3 Dec 2024 (actual)
- Study completion
- 3 Dec 2024 (actual)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pilot single arm non-randomized trial to determine the feasibility and acceptability of: 1) a tailored music-assisted relaxation and imagery intervention; 2) biological sample collection; and 3) mobile device patient-reported outcome (MDPRO) collection in adults hospitalized for pancreatic surgery experiencing acute pain.
Detailed description
After the participant's pancreatic surgery and during their post-surgery hospitalization, the RA will confirm participant eligibility and continued willingness to participate. About an hour later, the RA will return to the participant's room. Before collecting any data, the RA will ask the participant if their pain will permit them to continue and if they would like to proceed. If the participant responds affirmatively, the RA will document this in REDCap and then will proceed to collect baseline (Time 0) patient-reported outcomes (PROs) (i.e., 0-10 ratings of pain, stress, and anxiety) using a REDCap instrument administered on an iPad. The RA will not view the participant's PRO responses. If the participant is currently utilizing a patient-controlled analgesia (PCA) pump, the RA will collect measures of medication usage from the PCA pump. The RA will also collect a peripheral blood sample using a Spot On Sciences HemaSpot-HF. The research team chose the HemaSpot HF because it is an efficient and less invasive means of collecting capillary blood. Using the HemaSpot HF also poses less risk and discomfort to these patients who recently underwent major surgery. Following baseline measure collection, the RA will leave the participant's room.
Following Time 0, the MT-BC will deliver a standardized 30-minute MARI intervention, personalized to the participant's music and imagery preferences. Prior to the intervention, the MT-BC will verify the participant's music and imagery preferences discussed with the RA earlier in the day. During the MARI intervention, the MT-BC will provide live guitar accompaniment personalized to the participant's music preferences and read from a standardized script directing the participant to relax muscles of the body, practice deep breaths, and explore a relaxing place. This intervention will be recorded live and exported to either a study iOS device (e.g., iPod touch, iPhone) programmed to track MARI recording use or uploaded to a Box folder that will be shared with the participant to listen to on their own device. Following the MARI intervention, the MT-BC will briefly process the participant's experience by asking them how the experience was for them and to describe in their own words how they are feeling after the MARI intervention. (please see the attachment "MUSIC PUPS Post MARI Debriefing" for more details). The RA will export the MARI recording to a Box folder that the participant can access using the iOS device.
Immediately following the MARI intervention and post-intervention processing, the MT-BC will leave the participant's room. The RA will then enter the participant's room again. The RA will confirm that the participant is not in too much pain to continue and would like to continue with study procedures, documenting this in REDCap, before collecting post-intervention PROs and peripheral blood smear measures (Time 1). After collecting these measures, the RA will wait in the participant's room for 15 minutes. At 15-minutes post-intervention (Time 2), the RA will again collect PROs and a final peripheral blood smear measure.
Then, the RA will show the participant how to access the MARI recording and enter MDPRO measurements using either the study iOS device or their own device. The RA will instruct the participant to listen to the MARI intervention 3x/day and complete 3 MDPRO measurements each day until discharge. The iOS device will be locked to the participant's tray table to prevent it from being lost or stolen during the participant's hospitalization.
Following the collection of blood samples and PROs, the RA will conduct a review of the participant's medical record to collect data on the participant's demographics, clinical characteristics, and pain medications administered pre-intervention. The RA will enter this data into REDCap. Following sample collection, blood samples will be temporarily stored within the Connor Whole Health research office. Samples will then be shipped within 12 hours to Manoj Bhasin's lab at Emory University for storage and subsequent analysis.
The RA will meet with each participant every day, Monday through Friday, until discharge to troubleshoot any barriers to MARI use or MDPRO collection. Each day, before any troubleshooting or collecting any data, the RA , like on day one, will (1) check in with the treating physician and/or the clinical nurse; (2) ask the participant if their pain level will permit them to participate; and (3) ask the participant if they still want to participate in study procedures. If the participant responds affirmatively to continuing study procedures, the RA will document this in REDCap and then proceed with troubleshooting and data collection. The RA will record any barriers to MARI use and/or MDPRO collection (i.e., forgot, technical difficulties, off the floor for a procedure) as well as the participant's self-reported use of MARI in the last 24 hours. From Day 2 (i.e., the day after the live MARI intervention) until the participant is discharged from the hospital, the participant will receive three notifications per day (i.e., morning, afternoon, and evening) on the iOS device to complete MDPRO measures. The participant's use of the MARI recording will be tracked using file utilization measures available within Box.com. No PHI will be entered into the Box.com folder. The RA will also track the participant's use of pain medications (recorded in the EHR or on the PCA). All data will be stored in REDCap.
On the day of the participant's discharge from the hospital, the RA will collect the study iOS device, if applicable. The RA will provide the participant with the MARI recording via email and a Box.com link to allow the participant to access the recording post-discharge. If desired, the RA will also provide the recording via a compact disk. Following discharge, the study coordinator will arrange a time for the participant to complete a semi-structured interview over Zoom. One to two weeks after the participant's discharge from the hospital, researchers will meet with the participant over a HIPAA-compliant commercial tele-health platform to complete a semi-structured interview. If the participant is expected to be discharged over the weekend, the RA will provide the MARI recording resources on the Friday before the weekend in which the participant is to be discharged.
Interview procedures Interviews will take place over a HIPAA-compliant commercial tele-health platform (i.e., Zoom for Healthcare) or over the phone one-to-two weeks after the participant is discharged from the hospital. During that interview, a researcher will ask the participant about their experience in the study and what they thought about the MARI intervention. The researcher conducting the interviews remotely will be in a private room when interviewing the participants and will be certified in human subject protection and GCP, researched credentialed if applicable, and on the study personnel table. The interview will take about 20 minutes and will be recorded and then transcribed by hand.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Music assisted relaxation | Experimental | Behavioral: Music Assisted Relation Intervention (MARI)Participants will receive a tailored music-assisted relaxation and imagery intervention |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is able to speak and understand English
- Patient is scheduled to undergo a Whipple procedure or Distal pancreatectomy at UH Cleveland Medical Center with a standardized pain regimen
- Patient reports pain intensity of 4/10 or above on day 1 post-surgery
Key exclusion criteria (3 listed)
- Subject has a significant visual impairment that has not been corrected
- Subject has a significant hearing impairment that has not been corrected
- Subject has a significant cognitive impairment that would prevent subject from participating in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music Assisted Relation Intervention (MARI)A standardized 30-minute MARI intervention, personalized to the participant's music and imagery preferences. During the MARI intervention, the board certified music therapist (MT-BC) will provide live guitar accompaniment personalized to the participant's music preferences and read from a standardized script directing the participant to relax muscles of the body, practice deep breaths, and explore a relaxing place. | Behavioural | Music assisted relaxation |
Primary outcome
Delivery of a tailored music-assisted relaxation and imagery intervention (MARI)
Time frame: Day 1 of the patients post pancreatic surgery hospital stay
Percent of participants that complete the MARI intervention
Patient reported outcome (PRO) data collection
Time frame: During the length of patient's hospital stay, up to two weeks
Percent of completed patient reported outcomes surveys
Biological sample collection
Time frame: Day 1 of patient's post pancreatic surgery hospital stay
Percent of of viable biological samples collected
3 secondary outcomes
Enrollment Rate
Time frame: during the enrollment period of the study, up to two months
Attrition Rate
Time frame: While the study is active, up to 8 months
Rate of MARI recording use
Time frame: during patient's post pancreatic surgery hospital stay, up to two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Rodgers-Melnick, MPH, MT-BC principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Assisted Relation Intervention (MARI) in people with Whipple Procedure and Distal Pancreatectomy, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delivery of a tailored music-assisted relaxation and imagery intervention (MARI) (time frame: Day 1 of the patients post pancreatic surgery hospital stay). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.