Personalized Music Therapy and Agitation in Dementia

Not Applicable

• Conditions: Alzheimer's Disease; Vascular Dementia
• Interventions: Other: Personalized music

• Registration Number: NCT02147652
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-21
• Study First Submitted QC: 2014-05-21
• Study First Posted: 2014-05-28
• Study Start: 2014-10-14
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-25
• Primary Completion: 2020-06
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Personalized music	Personalized music	-

Primary Outcome Measures

Name	Time	Method
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.