Cancer Patients With Delirium Clinical Trial
Official title:
Music Therapy With Oncology Patients and Delirium: An Exploratory Study
| NCT number | NCT04104217 |
| Other study ID # | 19-270 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | September 23, 2019 |
| Est. completion date | August 18, 2023 |
| Verified date | August 2023 |
| Source | Memorial Sloan Kettering Cancer Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 17 |
| Est. completion date | August 18, 2023 |
| Est. primary completion date | August 18, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Memorial Sloan Kettering Cancer Center | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Memorial Sloan Kettering Cancer Center | New York University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | thematic analysis of data with music therapists | by interviews | 1 year | |
| Secondary | thematic analysis of data with caregivers, nurses, and patients | by interviews | 1 year |