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
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Dementia
- Sponsor
- The Hong Kong Polytechnic University
- Enrollment
- 81
- Locations
- 1
- Primary Endpoint
- Agitation status
- Status
- Not Yet Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Agitation status
Time Frame: 6 weeks
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.
Level of agitation
Time Frame: 6 weeks
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.
Intensity of agitation
Time Frame: 6 weeks
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).
Secondary Outcomes
- Agitation occurrence(6 weeks)
- Emotional or psychological distress of carer(6 weeks)