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

The Hong Kong Polytechnic University

Status: Not yet enrolling

Conditions: Dementia

Treatments: Behavioral: Individualized music playlist; Behavioral: Usual care; Behavioral: Preferred music

Study type: Interventional

Funder types: Other

Identifiers

NCT06104436

A0047147

Details and patient eligibility

About

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).

Full 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.

Enrollment: 81 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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81 participants in 3 patient groups

Individualized music playlist

Experimental group

Description:

Composed of preferred music genres sequenced according to the ISO-Principle in addition to usual care.

Treatment:

Behavioral: Individualized music playlist

Behavioral: Usual care

Preferred music

Active Comparator group

Description:

Preferred music genres played in random sequence in addition to usual care.

Treatment:

Behavioral: Usual care

Behavioral: Preferred music

Treatment as usual

Sham Comparator group

Description:

Usual care for agitation management.

Treatment:

Behavioral: Usual care