NCT03980782

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1 day until next milestone

Study Start

First participant enrolled

June 5, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 10, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

June 2, 2020

Status Verified

December 1, 2019

Enrollment Period

4 months

First QC Date

June 4, 2019

Last Update Submit

May 31, 2020

Conditions

Keywords

Delirium elderly Music therapyElderlyMusic Therapy

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

EXPERIMENTAL

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

Other: Music Therapy

Care as usual

NO INTERVENTION

Each 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.

Music Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

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

Study Sites (1)

Geisinger CMC

Scranton, Pennsylvania, 18510, United States

Location

MeSH Terms

Conditions

Delirium

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Adele Spegman, PhD

    Geisinger Clinic

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
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

Locations