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Not yet recruiting NCT06104436

Individualized Music Playlist Based on ISO Principle for De-escalation of Agitation in Dementia

No phase Interventional Dementia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Individualized music playlist, Preferred music, Usual care.
Who it may be relevant to
Registry conditions: Dementia. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effects of an Individualized Music Playlist Based on the ISOPrinciple for the Immediate De-escalation of Agitation in People With Dementia: a Randomized Controlled Trial

Overview

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).

Detailed description

1. Study design

\- Randomized controlled trial 2. Participants

\- Eighty-one older adults living with dementia and demonstrate significant agitation 3. Setting:

\- Residential care home 4. 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. 5. Comparison conditions

* Preferred music listening group: Preferred music listening played with an iPad and a wireless neckband speaker for 30 minutes when agitation begins in addition to usual care. * Usual care group: usual care 6. Outcomes

* Level of agitation measured with the Pittsburgh Agitation Scale * Intensity of agitation measured with the Positive and Negative Syndrome Scale - Excited Component * Agitation occurrence frequency measured with Cohen-Mansfield Agitation Inventory * Distress of formal caregivers related to agitation measured with Neuropsychiatric Inventory 7. Focus group interviews with the care staff will be conducted as a process evaluation for identifying the potential facilitators and barriers related to implementation.

Interventions

  • Behavioral Individualized music playlist
    Individualized music playlist composed of preferred music genres sequenced according to the ISO-Principle. It will be played at the state of agitation.
  • Behavioral Preferred music
    Preferred music is composed of the genres selected by the participants, and to be played at random sequence.
  • Behavioral Usual care
    Usual technique for calming agitated older adults with dementia

Primary outcome measures

  • Level of agitation [Time frame: 6 weeks]
  • Intensity of agitation [Time frame: 6 weeks]
  • Agitation status [Time frame: 6 weeks]
Secondary outcome measures (2)
  • Agitation occurrence [Time frame: 6 weeks]
  • Emotional or psychological distress of carer [Time frame: 6 weeks]

Eligibility criteria

Inclusion criteria

  • residents in long-term care facilities
  • diagnosed with any type of dementia
  • presented with significant agitation

Exclusion criteria

  • had been admitted to the facility for less than three months
  • are participating in other studies or experimental therapies
  • have a comorbid psychiatric illness
  • have physical illness that prevents them from listening to music

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Supportive care

Study locations

Hong Kong · 1 center
  • School of Nursing, The Hong Kong Polytechnic University — Hong Kong

Publications

  • 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. PMID 42400199

Identifiers

NCT: NCT06104436 · A0047147

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗