Individualized Music Playlist Based on ISO-Principle for De-escalating Agitation of People Living With Dementia
NCT ID: NCT04236557
Last Updated: 2023-09-28
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
24 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-11-01
Study Completion Date
2023-06-30
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Dementia
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
Study Groups
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Intervention
Group Type
EXPERIMENTAL
Music listening
Intervention Type
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.
Wait-list Control
Group Type
PLACEBO_COMPARATOR
Audio Book Listening
Intervention Type
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.
Interventions
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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.
Intervention Type
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.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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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;
* 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
* 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
Minimum Eligible Age
60 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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The Hong Kong Polytechnic University
OTHER
Sponsor Role
lead
Responsible Party
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Dr Daphne Cheung
Assistant Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Daphne Sze Ki Cheung, PhD
Role: PRINCIPAL_INVESTIGATOR
School of Nursing, The Hong Kong Polytechnic University
Locations
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School of Nursing, The Hong Kong Polytechnic University
Hong Kong, , Hong Kong
Site Status
Countries
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Hong Kong
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Other Identifiers
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HSEARS20190731001
Identifier Type: -
Identifier Source: org_study_id
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