- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03980782
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
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Scranton, Pennsylvania, United States, 18510
- Geisinger CMC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Music Intervention
Each participant will receive a 30 minute individual music intervention twice daily.
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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.
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No Intervention: Care as usual
Each participant will receive care as usual.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The effect of Music Therapy on the Incidence of Delirium in Older Acute Care Patients.
Time Frame: 2-3 months
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The incidence of delirium will be measured twice a day with the Confusion Assessment Method (CAM).
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2-3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Effect of a Music Intervention on the Severity of Delirium in Older Acute Care Patients
Time Frame: 2-3 months
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The severity of Delirium will be determined using the Confusion Assessment Method- S (CAM-S assessment) twice a day once participants are CAM positive.
The CAM-S, rate each symptom of delirium listed in the short CAM instrument as absent (0), mild (1), marked (2).
Acute onset or fluctuation is rated as absent or present.
Summarize these scores into a composite that ranges from 0-7 (higher scores indicate more severe delirium).
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2-3 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Effect of a Music Intervention on the Duration of Delirium in Older Acute Care Patients
Time Frame: 2-3 months
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Determine the duration of delirium will be determined by the number of days reporting a positive CAM...delirium resolution will be 48 hours without delirium.
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2-3 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Adele Spegman, PhD, Geisinger Clinic
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-0319
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.
Clinical Trials on Delirium
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Efficacy Care R&D LtdHadassah Medical OrganizationUnknownDelirium | Delirium, Cause Unknown | Delirium of Mixed Origin | Delirium Confusional State | Delirium Drug-InducedIsrael
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Imperial College Healthcare NHS TrustRecruitingCardiac Surgery | Intensive Care Unit Delirium | Post Operative DeliriumUnited Kingdom
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Chinese PLA General HospitalBeijing Tiantan HospitalRecruiting
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Mayo ClinicCompletedPost-Operative DeliriumUnited States
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University Hospital, Basel, SwitzerlandInnosuisse - Swiss Innovation AgencyRecruitingPostoperative Delirium (POD)Switzerland
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