Assessing the Effects of a Personalized Music Therapy With Headphones on Agitation in Patients With Dementia
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- Changes in agitation
研究概览
简要总结
Symptoms of agitation include abuse or aggressive behaviour toward self or others, appropriate behaviour performed with inappropriate frequency, or behaviours that are inappropriate according to social standards. In the later stages of dementia agitation can contribute significantly to patient distress and caregiver stress, and has been associated with poor quality of life. Previous research studies have shown some evidence that personalized music played in daily care situations reduces agitation. The purpose of this study is to evaluate the effects of personalized music therapy via headphones on agitation during hygiene care (grooming).
This study will involve 60 in-patients of the Geriatric Psychiatry ward of Toronto Rehabilitation Institute. The study would take place over the span of 2 weeks and would involve listening to personalized and either non-personalized or no music during daily hygiene care (grooming). Enrolment is completely voluntary and all personal data obtained will remain confidential.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of dementia with possible or probable cause of Alzheimer's disease, Vascular disease, mixed dementia;
- •moderate stage of dementia, a score of <20 on MMSE;
- •Age 60 to 90 inclusive;
- •Preserved hearing (hearing aids are permissible);
- •Pittsburgh agitation scale score of ≥ 3 on at least on 3 occasions over a period of 5 days.
排除标准
- •auditory deficits requiring correction beyond hearing aids.
- •no substitute decision maker available to indicate music preference and patient unable to answer for themselves.
- •recent acute event eg. MI, fractures, or major infection (not UTI)
- •patients receiving standing orders of medication for personal care
研究组 & 干预措施
Personalized music
干预措施: Personalized music (Other)
结局指标
主要结局
Changes in agitation
时间窗: 2 weeks
Changes in agitation as measured by the Pittsburgh agitation questionnaire and "as needed" psychotropic medications for agitation required during hygiene care will be quantitatively assessed. Statistical analyses will be performed to compare levels of agitation and use of "as needed" psychotropic medications for agitation with personalized music therapy with headphones and non-personalized music intervention or usual care.
次要结局
未报告次要终点
研究者
Carmela Tartaglia
MD, FRCPC
University Health Network, Toronto