Clinical trial NCT03980782: The Effect of Music Therapy on Delirium
Official title: The Effect of a Music Intervention on the Incidence, Severity and Duration of Delirium in Older Acute Care Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delirium
Keywords: Delirium elderly Music therapy
Elderly
Music Therapy
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2019-06-10
Enrollment: 44
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized control pilot study will be used to test the effect of a music therapist-developed, music listening intervention on delirium. Acutely ill patients will be randomized into a usual care control group or an experimental group receiving the music intervention twice daily for 30 minutes.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: Delirium is a complex, preventable, neuropsychiatric syndrome that is associated with higher mortality rates post discharge, increased hospital stays, increased mortality and an increased risk for developing dementia. Early, nonpharmacological treatment of delirium is preferable and supported by the literature to preserve patient safety. Music therapy is an evidence based, goal directed treatment process in which the music therapist and the patient maintain a state of well-being to achieve individualized patient goals. Music interventions are therapist developed and nurse initiated, in accordance to individual patient needs to maintain well-being, and show promise for improving attention and engagement. Understanding the effect of an individualized music intervention on the incidence, duration and severity of delirium has the potential to facilitate the use of cost-effective methods to modify individual environments to deliver appropriate care for acutely ill older adults. Purpose: The purpose of this study is to test the effect of an interdisciplinary music intervention on the incidence, severity and duration of delirium in older acutely ill adults. Methods: A randomized control pilot study will be used to test the effect of a music therapist-developed, music listening intervention on delirium. Acutely ill patients will be randomized into a usual care control group or an experimental group receiving the music intervention twice daily for 30 minutes. Data analysis: Descriptive statistics will be used to describe the sample. Independent t-tests will be used to examine group differences in delirium severity and duration. Chi-square analysis will be used to assess group differences in delirium incidence. Implications: For patients exposed to the stress of hospitalization, a music intervention may enhance delirium care and promote care that is safe and efficient.

Eligibility criteria: 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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Primary outcomes:
measure: The effect of Music Therapy on the Incidence of Delirium in Older Acute Care Patients.
timeFrame: 2-3 months
Secondary outcomes:
measure: The Effect of a Music Intervention on the Severity of Delirium in Older Acute Care Patients
timeFrame: 2-3 months
Other outcomes:
measure: The Effect of a Music Intervention on the Duration of Delirium in Older Acute Care Patients
timeFrame: 2-3 months
Locations:
city: Scranton
country: United States
facility: Geisinger CMC
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Adele Spegman, PhD
role: STUDY_DIRECTOR
References: