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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Agitation status
研究概览
简要总结
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).
详细描述
- Study design
- Randomized controlled trial
- Participants
- Eighty-one older adults living with dementia and demonstrate significant agitation
- Setting:
- Residential care home
- 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.
- Comparison conditions
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •residents in long-term care facilities
- •diagnosed with any type of dementia
- •presented with significant agitation
排除标准
- •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
研究组 & 干预措施
Individualized music playlist
Composed of preferred music genres sequenced according to the ISO-Principle in addition to usual care.
干预措施: Usual care (Behavioral)
Preferred music
Preferred music genres played in random sequence in addition to usual care.
干预措施: Preferred music (Behavioral)
Treatment as usual
Usual care for agitation management.
干预措施: Usual care (Behavioral)
Individualized music playlist
Composed of preferred music genres sequenced according to the ISO-Principle in addition to usual care.
干预措施: Individualized music playlist (Behavioral)
Preferred music
Preferred music genres played in random sequence in addition to usual care.
干预措施: Usual care (Behavioral)
结局指标
主要结局
Agitation status
时间窗: 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
时间窗: 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
时间窗: 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).
次要结局
- Agitation occurrence(6 weeks)
- Emotional or psychological distress of carer(6 weeks)