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The goal of this clinical trial is to evaluate the efficacy of an Individualized Music Playlist (InMP) composed of preferred music genres sequenced according to the ISO-Principle, for the immediate de-escalation of agitation in dementia, compared with preferred music (PM) and treatment as usual (TAU).
Study design
- Randomized controlled trial
Participants
- Eighty-one older adults living with dementia and demonstrate significant agitation
Setting:
- Residential care home
Intervention
- Individualized music listening intervention played with an iPad and a wireless neckband speaker for 30 minutes when agitation begins in addition to usual care.
Comparison conditions
Outcomes
Focus group interviews with the care staff will be conducted as a process evaluation for identifying the potential facilitators and barriers related to implementation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individualized music playlist | Experimental | Composed of preferred music genres sequenced according to the ISO-Principle in addition to usual care. |
|
| Preferred music | Active Comparator | Preferred music genres played in random sequence in addition to usual care. |
|
| Treatment as usual | Sham Comparator | Usual care for agitation management. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individualized music playlist | Behavioral | Individualized music playlist composed of preferred music genres sequenced according to the ISO-Principle. It will be played at the state of agitation. |
| Measure | Description | Time Frame |
|---|---|---|
| Level of agitation | Positive and Negative Syndrome Scale - Excitatory Component will be used for assessing the level of agitation. It 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. | 6 weeks |
| Intensity of agitation | Pittsburgh Agitation Scale will be used to assess the intensity of agitation. It is a brief measure of agitation that measures the severity of agitation in four general categories: aberrant vocalisation, motor agitation, aggressiveness and resisting care, on a scale from 0 (not present) to 4 (highest level). | 6 weeks |
| Agitation status | Behavioural Activity Rating Scale will be used to assess the agitation status. It contains a single-item question consisting of seven categories: 1=difficult or unable to rouse; 2=asleep, but responds normally to verbal or physical contact; 3=drowsy, appears sedated; 4=quiet and awake (normal level of activity); 5=signs of overt (physical or verbal) activity, calms down with instruction; 6=extremely or continuously active, not requiring restraint; 7=violent, requires restraint. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Agitation occurrence | Cohen-Mansfield Agitation Inventory will be used to assess the agitation occurence. A total CMAI score is obtained by summing all the individual items, giving a range from 29 to 203. A total score of >45 is usually regarded as clinically significant agitation. | 6 weeks |
| Emotional or psychological distress of carer |
| Measure | Description | Time Frame |
|---|---|---|
| Challenges and enablers in the implementation of the intervention | Semi-structured focus group interviews with the carers will be conducted. | 6 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daphne Sze Ki Cheung, PhD | Contact | +852 27664534 | daphne.cheung@polyu.edu.hk | |
| Daphne Sze Ki Cheung, PhD | Contact | +852 27664535 | daphne.s.k.cheung@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Daphne Sze Ki Cheung, PhD | The Hong Kong Polytechnic University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Nursing, The Hong Kong Polytechnic University | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42400199 | Derived | Cheung DSK, Tse JHY, Ho KHM, Macritchie J, Lai CKY, Buckwalter K, Wang S, Lee PH, Bressington D, Chan AHT, Ho GWK. Individualised Music Playlist Based on the Iso-Principle for De-Escalating Agitation in Older People With Dementia: Protocol for a RCT. Nurs Open. 2026 Jul;13(7):e70663. doi: 10.1002/nop2.70663. |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| D011595 | Psychomotor Agitation |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| Preferred music | Behavioral | Preferred music is composed of the genres selected by the participants, and to be played at random sequence. |
|
| Usual care | Behavioral | Usual technique for calming agitated older adults with dementia |
|
Neuropsychiatry Inventory Questionnaire will be used to assess the distress of caregivers. Caregiver distress is rated for each positive neuropsychiatric symptom domain on a scale anchored by scores from 0 to 5 points (0=no distress; 1=minimal distress; 2=mild distress; 3=moderate distress; 4=severe distress; and 5=very severe distress), giving a maximum score of 60. |
| 6 weeks |
| D001523 | Mental Disorders |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D011596 | Psychomotor Disorders |
| D019954 | Neurobehavioral Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |