NCT06104436

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 81 (estimated)
• Sponsor: The Hong Kong Polytechnic University · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dementia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2023-10-27
• Last updated: 2024-02-28

Locations

1 site across 1 country: Hong Kong