Personalized Music Therapy and Agitation in Dementia

NCT ID: NCT02147652

Last Updated: 2019-09-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-14
• Study Completion Date: 2020-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Personalized music

Group Type: EXPERIMENTAL

Personalized music

Intervention Type: OTHER

Interventions

Personalized music

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Carmela Tartaglia

MD, FRCPC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carmela Tartaglia, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

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

References

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.

Reference Type: DERIVED

PMID: 40049590 (View on PubMed)

Other Identifiers

14-7490-DE

Identifier Type: -

Identifier Source: org_study_id