Personalized Music Therapy and Agitation in Dementia

Sponsor

University Health Network, Toronto (Other)

Overall Status

Unknown status

CT.gov ID

NCT02147652

Collaborator

(none)

Enrollment

Arm

67.6

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Symptoms of agitation include abuse or aggressive behaviour toward self or others, appropriate behaviour performed with inappropriate frequency, or behaviours that are inappropriate according to social standards. In the later stages of dementia agitation can contribute significantly to patient distress and caregiver stress, and has been associated with poor quality of life. Previous research studies have shown some evidence that personalized music played in daily care situations reduces agitation. The purpose of this study is to evaluate the effects of personalized music therapy via headphones on agitation during hygiene care (grooming).

This study will involve 60 in-patients of the Geriatric Psychiatry ward of Toronto Rehabilitation Institute. The study would take place over the span of 2 weeks and would involve listening to personalized and either non-personalized or no music during daily hygiene care (grooming). Enrolment is completely voluntary and all personal data obtained will remain confidential.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer's Disease Vascular Dementia	Other: Personalized music	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Assessing the Effects of a Personalized Music Therapy With Headphones on Agitation in Patients With Dementia

Actual Study Start Date :

Oct 14, 2014

Anticipated Primary Completion Date :

Jun 1, 2020

Anticipated Study Completion Date :

Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Personalized music	Other: Personalized music

Arm

Intervention/Treatment

Experimental: Personalized music

Other: Personalized music

Outcome Measures

Primary Outcome Measures

Changes in agitation [2 weeks]
Changes in agitation as measured by the Pittsburgh agitation questionnaire and "as needed" psychotropic medications for agitation required during hygiene care will be quantitatively assessed. Statistical analyses will be performed to compare levels of agitation and use of "as needed" psychotropic medications for agitation with personalized music therapy with headphones and non-personalized music intervention or usual care.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of dementia with possible or probable cause of Alzheimer's disease, Vascular disease, mixed dementia;
moderate stage of dementia, a score of <20 on MMSE;
Age 60 to 90 inclusive;
Preserved hearing (hearing aids are permissible);
Pittsburgh agitation scale score of ≥ 3 on at least on 3 occasions over a period of 5 days.

Exclusion Criteria:

auditory deficits requiring correction beyond hearing aids.
no substitute decision maker available to indicate music preference and patient unable to answer for themselves.
recent acute event eg. MI, fractures, or major infection (not UTI)
patients receiving standing orders of medication for personal care

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Health Network, Toronto

Investigators

Principal Investigator: Carmela Tartaglia, MD, FRCPC, Assistant Professor, University of Toronto; Toronto Western Hospital, University Health Network; Tanz Centre for Research in Neurodegenerative Disease