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

September 26, 2023 updated by: Dr Daphne Cheung, The Hong Kong Polytechnic University

Individualized Music Playlist Based on ISO-Principle for De-escalating Agitation of People Living With Dementia: A Randomized Controlled Feasibility Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. Aims and objectives:

    This study is to evaluate the feasibility of the individualized music playlist based on ISO-Principle for de-escalating agitation of nursing home residents living with dementia.

    Objectives are as below:

    1. To evaluate the feasibility of the intervention in terms of recruitment, retention, and acceptability.
    2. To examine the preliminary effects of the intervention on participants' agitation, stress and emotion as compared to control group.
    3. To evaluate suitability of outcome assessment instruments.

  2. Methods:

    1. Design:

      • A two arms randomized controlled feasibility trial.

    2. Participants and setting:

      • The study participants will be recruited from participating residential care homes for the elderly in Hong Kong.

    3. Intervention group

      • Will receive usual care and a 30-minute personalized playlist with the preferred music sequenced according to ISO-Principle will be provided when the participant become agitated during the 6-week project period.

    4. Control group

      • Will receive usual care and a 30-minute audio recording of book reading wen the participant become agitated during the 6-week project period. They will receive a personalized playlist with the preferred music sequenced according to ISO-Principle when all the data collection is done.

    5. Outcomes:

      • recruitment rate, attrition rate, acceptability (field observation, comments from staffs), practicality (adherence to the intervention protocol), and any adverse reactions.
      • agitation severity (Behavioural Activity Rating Scale, Positive and Negative Syndrome Scale Excited Component), heart rate, emotional states (Mood scales derived from DSM-V), before and after listening to the playlist
      • agitation frequency (Cohen-Mansfield Agitation Inventory) and behavioral and psychological symptoms of dementia frequency (Neuropsychiatric Inventory- Questionnaire), at baseline and after 6 weeks

    6. Sample size:

      • 84 participants

    7. Randomization:

      • Participants will be randomly assigned to either intervention or control group at 1:1 ratio.

    8. Data analysis strategies:

      • Descriptive statistics will be used to report the feasibility indicators.
      • The treatment effect on agitation intensity, stress and mood as compared to control group before and after listening to music or control condition for 30 minutes during agitated state, will be analysed using Generalized Estimating Equation (GEE) method.
      • For evaluating the efficacy of music listening in reducing the occurrence frequency of agitation and other behavioural and psychological symptoms of dementia, the scores at baseline and post-intervention (i.e. after 6 weeks) between two groups will be analysed with Mixed ANOVA.
      • Significance level is set at p<.05 with 95% Confidence Interval.
    9. Ethical consideration:

Ethics approval will be obtained from the University before recruiting the participants. Proxies and participants will be informed about the possible risks and benefits of the participation, and it is voluntary and free to withdraw at any time. Procedural consent will be sought too.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • School of Nursing, The Hong Kong Polytechnic University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Behavioral: Music listening
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.
Placebo Comparator: Wait-list Control
Behavioral: Audio Book Listening
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: At baseline
The percentage of eligible participants who finally agreed to join the project
At baseline
Attrition rate
Time Frame: The 6th week
The percentage of recruited participant dropped out from the project prematurely
The 6th week
Satisfaction rate
Time Frame: At the end of the 6th week
Satisfaction of the intervention rated by staff using self-developed rating scale
At the end of the 6th week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
State of Arousal
Time Frame: During the 6-week study period, before and immediate after listening to the audio when agitated
To be measured with Behavioural Activity Rating Scale (BARS): a single-item question indicating the condition of the participant in 7-point Likert-scale ranging from 1 - difficult or unable to rouse to 7 - violent, requires restraint. The inter-rater reliability was 0.999 and it is found sensitive in capturing the change of agitation after medication.
During the 6-week study period, before and immediate after listening to the audio when agitated
Mood States
Time Frame: During the 6-week study period, before and immediate after listening to the audio when agitated

Mood scales derived from Diagnostic and Statistics Manual - Edition V. It consists of 16 items (8 items for negative mood and positive mood, respectively). with a 0-3 point rating on mood severity.

the total score of subscale (negative and positive mood) will be calculated. Higher score refers to stronger mood observed.
During the 6-week study period, before and immediate after listening to the audio when agitated
Agitation frequency
Time Frame: Screening, Baseline, at the end of the project (i.e. the 6th week)

Cohen-Mansfield Agitation Inventory (CMAI) will be used.

The CMAI is a caregivers' rating questionnaire consisting of 29 agitated behaviors, each rated on a 7-point scale of frequency. Ratings pertain to the two weeks preceding the administration of the CMAI.

total score of sub-scale of three factors (Aggressive behaviour, physical non-agggressive behviour, and verbal agitted behaviours) will be calculated. A higher score means more frequent agitation.
Screening, Baseline, at the end of the project (i.e. the 6th week)
Behavioural and psychological symptoms of dementia frequency
Time Frame: Screening, Baseline, at the end of the project (i.e. the 6th week)

The behavioural and psychological symptoms of dementia frequency will be assessed with Neuropsychiatric Inventory Questionnaire (NPI-Q).

It consists of 12 items covering the following domains: Hallucinations, Delusions, Agitation/aggression, Dysphoria/depression, Anxiety, Irritability, Disinhibition, Euphoria, Apathy, Aberrant motor behavior, Sleep and night-time behavior change, and Appetite and eating change. Each NPI-Q item is rated by the caregiver as 0-3 points according to levels of increasing severity and the score maximums are determined by multiplying the number of items by 3.
Screening, Baseline, at the end of the project (i.e. the 6th week)
Heart rate
Time Frame: Continuously during the 6-week study period
Will be measured with wearable sensor
Continuously during the 6-week study period
Agitation Intensity
Time Frame: During the 6-week study period, before and immediate after listening to the audio when agitated
To be measured with Positive and Negative Syndrome Scale Excited Component (PANSS-EC). The PANSS-EC consists of 5 items: excitement, tension, hostility, uncooperativeness, and poor impulse control. The 5 items from the PANSS-EC are rated from 1 (not present) to 7 (extremely severe); scores range from 5 to 35; mean scores ≥ 20 clinically correspond to severe agitation. This set of items detects differences between drug and placebo when evaluating acute agitation and aggression in psychiatric patients [5,7-10] with different psychiatric pathologies.
During the 6-week study period, before and immediate after listening to the audio when agitated

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Investigators

  • Principal Investigator: Daphne Sze Ki Cheung, PhD, School of Nursing, The Hong Kong Polytechnic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

December 6, 2019

First Submitted That Met QC Criteria

January 17, 2020

First Posted (Actual)

January 22, 2020

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSEARS20190731001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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