Individualized Music Playlist Based on ISO-Principle for De-escalating Agitation of People Living With Dementia
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|ClinicalTrials.gov Identifier: NCT04236557|
Recruitment Status : Not yet recruiting
First Posted : January 22, 2020
Last Update Posted : January 22, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Dementia||Behavioral: Music listening Behavioral: Audio Book Listening||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Individualized Music Playlist Based on ISO-Principle for De-escalating Agitation of People Living With Dementia: A Randomized Controlled Feasibility Study|
|Estimated Study Start Date :||February 2020|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||December 2021|
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.
- Recruitment rate [ Time Frame: At baseline ]The percentage of eligible participants who finally agreed to join the project
- Attrition rate [ Time Frame: The 6th week ]The percentage of recruited participant dropped out from the project prematurely
- Satisfaction rate [ Time Frame: At the end of the 6th week ]Satisfaction of the intervention rated by staff using self-developed rating scale
- 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.
- 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.
- 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.
- 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.
- Heart rate [ Time Frame: Continuously during the 6-week study period ]Will be measured with wearable sensor
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04236557
|Contact: Daphne Sze Ki Cheung, PhD||(852)email@example.com|
|School of Nursing, The Hong Kong Polytechnic University|
|Hong Kong, Hong Kong|
|Contact: Daphne Cheung, PhD (852)27664534 firstname.lastname@example.org|
|Principal Investigator: Xu Bai, PhD|
|Sub-Investigator: Wing Leung Daniel Lai, PhD|
|Sub-Investigator: Hong Paul Lee, PhD|
|Sub-Investigator: Kam Yuk Claudia Lai, PhD|
|Sub-Investigator: Hok Man Ken Ho, PhD|
|Principal Investigator:||Daphne Sze Ki Cheung, PhD||School of Nursing, The Hong Kong Polytechnic University|