Personalized Music Therapy and Agitation in Dementia

NCT02147652 | Unknown

• 1 other identifier: 14-7490-DE
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alzheimer's Disease; Vascular Dementia

Keywords

moderate dementia; severe dementia; Alzheimer's disease; Vascular dementia; agitation; personalized music therapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Personalized music

EXPERIMENTAL

Other: Personalized music

Interventions

Personalized music OTHER

Personalized music

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Related Publications (1)

• van der Steen JT, van der Wouden JC, Methley AM, Smaling HJA, Vink AC, Bruinsma MS. Music-based therapeutic interventions for people with dementia. Cochrane Database Syst Rev. 2025 Mar 7;3(3):CD003477. doi: 10.1002/14651858.CD003477.pub5.

  PMID: 40049590 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Dementia, Vascular; Dementia; Psychomotor Agitation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Dyskinesias; Neurologic Manifestations; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Study Officials

• Carmela Tartaglia, MD, FRCPC

  Assistant Professor, University of Toronto; Toronto Western Hospital, University Health Network; Tanz Centre for Research in Neurodegenerative Disease

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FRCPC

Study Record Dates

• First Submitted: May 21, 2014
• First Posted: May 28, 2014
• Study Start: October 14, 2014
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: September 25, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share