The Effect of Music Therapy on Delirium

Delirium Clinical Trial

Official title:

The Effect of a Music Intervention on the Incidence, Severity and Duration of Delirium in Older Acute Care Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03980782
• Other study ID #: 2019-0319
• Status: Completed
• Phase: N/A
• Start date: June 5, 2019
• Est. completion date: September 30, 2019

Study information

• Verified date: December 2019
• Source: Geisinger Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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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Related Conditions & MeSH terms

• Delirium

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Geisinger CMC	Scranton	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Geisinger Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Effect of a Music Intervention on the Duration of Delirium in Older Acute Care Patients	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.	2-3 months
Primary	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	The Effect of a Music Intervention on the Severity of Delirium in Older Acute Care Patients	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).	2-3 months