Clinical trial NCT06104436: Individualized Music Playlist Based on ISO Principle for De-escalation of Agitation in Dementia
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dementia
Keywords: Dementia
Agitation
Music
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2023-10-27
Enrollment: 81
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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

Primary outcomes:
measure: Level of agitation
timeFrame: 6 weeks
measure: Intensity of agitation
timeFrame: 6 weeks
measure: Agitation status
timeFrame: 6 weeks
Secondary outcomes:
measure: Agitation occurrence
timeFrame: 6 weeks
measure: Emotional or psychological distress of carer
timeFrame: 6 weeks
Other outcomes:
measure: Challenges and enablers in the implementation of the intervention
timeFrame: 6 weeks
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Nursing, The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Daphne Sze Ki Cheung, PhD
role: PRINCIPAL_INVESTIGATOR
References: