The Effect of Music Therapy on Delirium

NCT ID: NCT03980782

Last Updated: 2020-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-05
• Study Completion Date: 2019-09-30

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.

Conditions

Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Music Intervention

Each participant will receive a 30 minute individual music intervention twice daily.

Group Type: EXPERIMENTAL

Music Therapy

Intervention Type: OTHER

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.

Care as usual

Each participant will receive care as usual.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Music Therapy

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.

Intervention Type: OTHER

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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• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Geisinger Clinic

OTHER

Sponsor Role: lead

Responsible Party

Mary Kovaleski

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adele Spegman, PhD

Role: STUDY_DIRECTOR

Geisinger Clinic

Locations

Geisinger CMC

Scranton, Pennsylvania, United States

Countries

United States

Other Identifiers

2019-0319

Identifier Type: -

Identifier Source: org_study_id