Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-29 @ 10:19 PM
Study NCT ID:
NCT04236557
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2019-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Individualized Music Playlist Based on ISO-Principle for De-escalating Agitation of People Living With Dementia
Sponsor:
The Hong Kong Polytechnic University
Organization:
Study Overview
Official Title:
Individualized Music Playlist Based on ISO-Principle for De-escalating Agitation of People Living With Dementia: A Randomized Controlled Feasibility Study
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: