- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04104217
A Study of the Experience of Music Therapy in Cancer Patients With Delirium
Music Therapy With Oncology Patients and Delirium: An Exploratory Study
The purpose of this study is to improve our understanding of the experience of music therapy by cancer patients with delirium, and the experience of music therapists working with these patients. The researchers are focusing on patients with delirium because of the challenging symptoms of this condition.
At MSK, music therapy is routinely used in patients with cancer. Music therapy sessions are done at the patient's bedside, where the music therapist plays live music on a guitar, keyboard, harp, or percussion instrument, sometimes as accompaniment to singing.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- adult patients (ages 18-75) with delirium
- referred for and receive music therapy.
- were identified as having delirium by the Confusion Assessment Method (CAM), Confusion Assessment Method for ICU patients (CAM-ICU) or a documented diagnosis by a clinician from the Department of Psychiatry and Behavioral Sciences in the patient's electronic medical record (EMR).
- Patients that have had music therapy in the past will be eligible for the study
- Only patients that recover from delirium (per CAM, CAM-ICU, or progress note by a clinician from the Department of Psychiatry and Behavioral Sciences) after receiving music therapy will be approached for interview by the researcher.
This study will also include their caregivers, music therapists, primary nurse, and bedside companions who have participated in or observed the participants' response to music therapy.
The music therapist participants are:
- Board-certified senior music therapists with 10 or more years experience in the research site who sign a blanket consent form to participate in study.
- Assigned to eligible patients by Integrative Medicine Service Client Service Representative (CSR).
The caregivers are:
- Family or unrelated adult (>18) caregivers who observed bedside music therapy session(s) with patients meeting inclusion criteria
The staff caregivers are:
- Primary nurse caring for eligible patients who receive their first music therapy session while experiencing delirium.
- Patient care technicians (PCT) assigned as bedside companions for eligible patients who receive music therapy
Exclusion Criteria:
- have a known hearing impairment
- do not speak English.
- are heavily sedated, comatose, or expected to be discharged or expire within 48 hours
- have known comorbidities of delirium tremens, steroid psychosis, or dementia
Caregivers will be excluded from the study if they do not speak English. Music therapists, nurses, or bedside companions will be excluded if they are not assigned to eligible patients.
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
patients
Participate in 30-60 minute interviews after each music therapy session.
|
Music therapy sessions may last 20-60 minutes, with length and frequency to be determined mutually (generally 1-3 times per week).
Music therapy sessions are done at the patient's bedside, where the music therapist plays live music on a guitar, keyboard, harp, or percussion instrument, sometimes as accompaniment to singing.
Each interview will be conducted in person in a private setting (with the exception of caregivers, who have the option to conduct interviews over the phone if it is not feasible to take place in the hospital).
Each interview will follow a semi-structured interview guide and will ask for consent to audio record the interviews .
|
caregivers
Participate in 30-60 minute interviews after each music therapy session (ideally within 3 days).
|
Music therapy sessions may last 20-60 minutes, with length and frequency to be determined mutually (generally 1-3 times per week).
Music therapy sessions are done at the patient's bedside, where the music therapist plays live music on a guitar, keyboard, harp, or percussion instrument, sometimes as accompaniment to singing.
Each interview will be conducted in person in a private setting (with the exception of caregivers, who have the option to conduct interviews over the phone if it is not feasible to take place in the hospital).
Each interview will follow a semi-structured interview guide and will ask for consent to audio record the interviews .
|
nurses
Participate in 10-15 minute interviews after initial music therapy session.
|
Music therapy sessions may last 20-60 minutes, with length and frequency to be determined mutually (generally 1-3 times per week).
Music therapy sessions are done at the patient's bedside, where the music therapist plays live music on a guitar, keyboard, harp, or percussion instrument, sometimes as accompaniment to singing.
Each interview will be conducted in person in a private setting (with the exception of caregivers, who have the option to conduct interviews over the phone if it is not feasible to take place in the hospital).
Each interview will follow a semi-structured interview guide and will ask for consent to audio record the interviews .
|
music therapists
Music therapist will notify the researcher if he/she has provided music therapy for a patient who is identified as having delirium.
Music therapists will also be interviewed about the clinical process after initial and follow up music sessions.
|
Each interview will be conducted in person in a private setting (with the exception of caregivers, who have the option to conduct interviews over the phone if it is not feasible to take place in the hospital).
Each interview will follow a semi-structured interview guide and will ask for consent to audio record the interviews .
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
thematic analysis of data with music therapists
Time Frame: 1 year
|
by interviews
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
thematic analysis of data with caregivers, nurses, and patients
Time Frame: 1 year
|
by interviews
|
1 year
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Holly Mentzer, MA, LCAT, MT-BC, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-270
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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