Evaluating the Effects of Music Interventions on Hospitalised People With Dementia
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Mini Mental State Examination: baseline cf. post intervention scores.
研究概览
简要总结
Dementing syndromes are, for the most part, incurable. People with dementia become highly dependent and frequently have to move from their homes into residential aged care facilities.
Medications aimed at reducing the severity of a number of symptoms associated with the different types of dementia have had only modest success.
Increasingly, people with dementia, their families and carers are turning to supplementary or alternative approaches to the management of their symptoms. There are many published reports describing the successful use of music therapy in reducing the severity of many symptoms of dementia. These include reports of improved memory, improved language skills, reduced anxiety and depression, reductions in agitation and disruptive behaviours and better social relationships with family, peers and carers. However, the quality of evidence they provide for the most part fails meet the standards of evidence required by health care providers. This clinical trial will examine the effects of a music therapy intervention.
The study will recruit 180 patients in sub-acute hospital wards. Participants will be randomly placed in groups that receive either occupational therapy or music therapy. Before the therapy programs begin, we will use questionnaires to measure memory function, language ability, orientation and mood. We will also record brain activity from the surface of the scalp, blood pressure and pulse to examine physiological responses. The same measures will be repeated after the 3 weeks of therapy to determine whether there has been any improvement in the symptoms of the participants and whether the group that had music therapy showed greater improvement than the group that had occupational therapy. We will make a video recording during one therapy session to allow us to observe levels of engagement and to assess changes in facial expressions. This will provide information about the immediate effects of music on mood and social interaction. The information we collect about brain activity and blood pressure will help us to understand how music therapy might bring about changes in the symptoms of dementia. This understanding will be useful in developing better applications of music therapy. It will also add to our current knowledge about how the various diseases cause the problems they do.
In summary, the primary aim of the project is to determine whether the reported effects of music therapy are supported by objective evidence.
详细描述
RATIONALE: Dementia presents a significant health problem throughout the world. We will compare the effects of a music therapy intervention and an occupational therapy intervention in a randomised controlled trial conducted with hospitalised older people with dementia.
The study will employ physiological, psychometric and observer-rated measures to monitor change over time in a range of parameters including cognitive and behavioural responses, mood and agitation, CNS function, facial expression and blood pressure. The battery of psychometric instruments consists of well-validated and reliable measures. Cognitive status will be measured using The Mini-Mental State Exam (Folstein et al, 1975) and the Hierarchic Dementia Scale (Cole and Dastoor, 1996) Mood will be assessed using the Geriatric Depression Scale (Yesavage et al., 1983). A wide range of behaviours will be assessed with the Cohen-Mansfield Agitation Inventory (CMAI) (Cohen-Mansfield, J., 1986). To monitor changes related to the music and non-music interventions, we will employ the EEG methods that will detect changes in dementia-related generalised, global slowing of the EEG as well as more localised changes at sites in anterior and posterior regions of both cerebral hemispheres. EEG-coherence methods will be used to assess intrahemispheric and interhemispheric functional interactions. We will also record auditory evoked potentials to evaluate changes in the attentional status of participants. This will provide data that will detect change over time in response to the interventions. The Facial Activation Coding System (Ekman & Friesen, 1978) allows systematic analysis of facial expressions from video-taped recordings. It has been used with people with dementia to provide valid and reliable quantitative estimates of pain states (Hadjistavropoulos et al., 2000). It will be employed here to quantitatively evaluate changes in facial expression that occur during the intervention sessions. This will allow us to observe within group changes and between group differences in the range of expressive responses. Changes in blood pressure will provide a means of evaluating physiological responses to the interventions.
AIMS: The primary aim of the present study is to determine whether the symptomatic improvements attributed to music therapy are supported by empirical evidence derived from a battery of psychometric and observational measures. A second aim is to determine whether neurophysiological measures (EEG frequency, EEG-coherence, EP) and vascular activity (blood pressure) reflect central nervous system and autonomic changes that directly correlate with reductions in dementia-related symptoms.
Specifically, the study will investigate the following hypotheses -
- Music employed as a therapeutic medium will reduce symptomatic cognitive, behavioural, emotional and functional deficits associated with dementia.
- Symptomatic changes will correlate with physiological changes. METHODOLOGY: This study will take advantage of an established collaborative network between the Department of Psychiatry, The University of Melbourne, The National Ageing Research Institute, The Cognitive, Dementia and Memory Service (CDAMS) at The Royal Melbourne Hospital and the CDAMS at the St George's Hospital campus of St Vincent's Health. The research team covers several disciplines including aged psychiatry, neuropsychiatry, geriatric medicine, neuropsychology, behavioural neuroscience, electrophysiology, music and music therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of dementia
排除标准
- •acute medical conditions (eg pneumonia, cardiac failure)
- •primary psychiatric conditions (eg schizophrenia)
- •severe hearing impairment
结局指标
主要结局
Mini Mental State Examination: baseline cf. post intervention scores.
Hierarchic Dementia Scale: baseline cf. post intervention scores.
Geriatric Depression Scale: baseline cf. post intervention scores.
Note: post intervention measures taken within 24 hours of final therapeutic intervention session
次要结局
- EEG fast/slow ratio: baseline cf. post intervention scores.
- EEG Coherence: baseline cf. post intervention scores.
- EEG evoked potentials:baseline cf. post intervention scores.
- Note: post intervention measures taken within 24 hours of final therapeutic intervention session