Individualized Music Playlist Based on ISO-Principle for De-escalating Agitation of People Living With Dementia

NCT04236557 | Completed

• 1 other identifier: HSEARS20190731001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Abstract: Agitation is exhibited by almost every dementia patient during the course of illness, and that leads to detrimental consequences on both patients and caregivers. Listening to preferred music is found useful in reducing the agitation frequency of people with dementia. However, the music intervention is usually provided regularly and the music psychotherapy ISO-Principle is ignored in published studies. The ISO-Principle that commonly adopted in music therapy using live-music, suggests that characteristics of music being played (e.g. tempo, melody and lyrics) should match with the current state (e.g. manic/depressive) of the client, and gradually modify these characteristics to the desired state. This randomized feasibility trial aims to evaluate the feasibility of using individualized music playlist with the music genres sequenced according to the ISO-Principle, for de-escalating agitation of people with dementia, and provide preliminary evidence on efficacy. Eighty-four nursing home residents with agitation will be randomly allocated into music listening or control groups. Acceptability, implementation and practicality, as well as efficacy (in terms of agitation intensity, stress and mood states before and after the de-escalating music intervention or control condition; and occurrence of agitation and other behavioural and psychological symptoms of dementia before and after the 6-week observation period). Feasibility indicators will be reported descriptively. The efficacy of (1) music listening in de-escalating symptoms and (2) reducing occurrence frequency of symptoms after 6 weeks, will be analysed with Generalized Estimating Equation. If the findings are positive, the intervention have a great potential to be adopted as the gold standard of care in the nursing homes to solve a common yet detrimental clinical problem.

Conditions

Dementia

Keywords

Music; Agitation; Dementia; De-escalation

Outcome Measures

Primary Outcomes (3)

• Recruitment rate

  The percentage of eligible participants who finally agreed to join the project

  At baseline

• Attrition rate

  The percentage of recruited participant dropped out from the project prematurely

  The 6th week

• Satisfaction rate

  Satisfaction of the intervention rated by staff using self-developed rating scale

  At the end of the 6th week

Secondary Outcomes (6)

• State of Arousal

  During the 6-week study period, before and immediate after listening to the audio when agitated

• Mood States

  During the 6-week study period, before and immediate after listening to the audio when agitated

• Agitation frequency

  Screening, Baseline, at the end of the project (i.e. the 6th week)

• Behavioural and psychological symptoms of dementia frequency

  Screening, Baseline, at the end of the project (i.e. the 6th week)

• Heart rate

  Continuously during the 6-week study period

Study Arms (2)

Intervention

EXPERIMENTAL

Behavioral: Music listening

Wait-list Control

PLACEBO COMPARATOR

Behavioral: Audio Book Listening

Interventions

Music listening BEHAVIORAL

Other than usual care, subjects will listen to a 30-min individualized playlists with preferred music genres sequenced by a registered music therapist according to the ISO-Principle when agitated.

Intervention

Audio Book Listening BEHAVIORAL

Other than usual care, subjects will listen to to a 30-min audio-script of book reading in Cantonese (a common dialect in Hong Kong being spoken by most people) when agitated.

Wait-list Control

Eligibility Criteria

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

You may qualify if:

• Nursing home residents with medical diagnosed of any type of dementia; presented with significant agitation in the past two weeks before recruitment;
• expected to be present in the facility every Monday to Friday during the study period; and
• Aged 60 or above;

You may not qualify if:

• Nursing home residents who were admitted to the nursing home for less than 3 months;
• participating in other studies or experimental therapies, or blinded treatments;
• those with comorbid psychiatric illness such as depression, schizophrenia;
• or those with uncorrectable hearing impairment.
• Notes:
• Concurrent psychotropic medications over the study period is allowed but any change in the prescriptions will be monitore

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

School of Nursing, The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

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MeSH Terms

Conditions

Dementia; Psychomotor Agitation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; 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

• Daphne Sze Ki Cheung, PhD

  School of Nursing, The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: January 22, 2020
• Study Start: November 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)