Personalized Music Therapy and Agitation in Dementia

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02147652
• Other study ID #: 14-7490-DE
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 14, 2014
• Est. completion date: June 2020

Study information

• Verified date: September 2019
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Dementia
• Dementia, Vascular
• Psychomotor Agitation
• Vascular Dementia

Intervention

Other:
• Personalized music

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in agitation	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.	2 weeks