The Effect of Music Therapy on Delirium
The Effect of a Music Intervention on the Incidence, Severity and Duration of Delirium in Older Acute Care Patients
1 other identifier
interventional
44
1 country
1
Brief Summary
The purpose of this study is to test the effect of a twice daily, 30-minute, interdisciplinary, music therapist developed, nurse initiated, music listening intervention on acutely ill older patients as compared to patients who receive care as usual. Half of the participants will receive music therapy and the other half will receive care as usual.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2019
CompletedStudy Start
First participant enrolled
June 5, 2019
CompletedFirst Posted
Study publicly available on registry
June 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2019
CompletedJune 2, 2020
December 1, 2019
4 months
June 4, 2019
May 31, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The effect of Music Therapy on the Incidence of Delirium in Older Acute Care Patients.
The incidence of delirium will be measured twice a day with the Confusion Assessment Method (CAM).
2-3 months
Secondary Outcomes (1)
The Effect of a Music Intervention on the Severity of Delirium in Older Acute Care Patients
2-3 months
Other Outcomes (1)
The Effect of a Music Intervention on the Duration of Delirium in Older Acute Care Patients
2-3 months
Study Arms (2)
Music Intervention
EXPERIMENTALEach participant will receive a 30 minute individual music intervention twice daily.
Care as usual
NO INTERVENTIONEach participant will receive care as usual.
Interventions
Individualized music therapy developed playlist(s) that will be used based upon the latest Confusion Assessment Method result (hypoactive, hyperactive or no delirium) delivered twice daily.
Eligibility Criteria
You may qualify if:
- Age 65 or older Admitted to the Progressive Care Unit (PCU), must be able to speak English Must be able to hear music through headphones. Must not have a documented history of dementia Must not have a documented history of permanent cognitive impairment, Must not be delirious at the beginning of the study (CAM negative) Must be able to sign a consent form.
You may not qualify if:
- Age less than 65, Not admitted to the Progressive Care Unit, Positive for delirium (CAM positive) Does not speak English, Has a hearing impairment, Documented history of dementia Documented history of permanent cognitive decline Expected death within 24 hours of enrollment, Transferred off the floor Unable to sign consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Geisinger Cliniclead
Study Sites (1)
Geisinger CMC
Scranton, Pennsylvania, 18510, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Adele Spegman, PhD
Geisinger Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 4, 2019
First Posted
June 10, 2019
Study Start
June 5, 2019
Primary Completion
September 30, 2019
Study Completion
September 30, 2019
Last Updated
June 2, 2020
Record last verified: 2019-12