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临床试验/NCT01744600
NCT01744600已完成不适用

Music Therapy in Methodist Homes: a Cluster Randomised Controlled Trial Including Mixed Methods Analysis Investigating the Efficacy of the Impact of a Music Therapy Programme on Caring for People With Dementia Who Have Behavioural Symptoms.

Methodist Homes for the Aged4 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2013年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
27
试验地点
4
主要终点
Neuropsychiatric Inventory

研究概览

简要总结

The study is a cluster randomised control trial, which aims to investigate the effectiveness of music therapy in minimising Behavioural and Psychological Symptoms of Dementia (BPSD) in older adults with dementia. In particular, the study aims to identify the main components of music therapy that are key in achieving this. The study will also explore carers' perceptions of music therapy, and investigate whether carers become more attentive to patients' needs and more able to manage patients' BPSD as a result of the music therapy programme.

详细描述

While music therapy has been noted to be an effective intervention in decreasing agitation and disruptive behaviour in adults with dementia (Livingston et al, 2005), these effects have only been demonstrated during and immediately after sessions, arguably due to the progressive nature of dementia. To achieve long-lasting therapeutic change, it seems necessary to consider the specific elements that work in music therapy, and extract them for use within other activities. It is hypothesised that the use of such elements within additional activities and care provision, alongside regular music therapy sessions, may result in decreasing residents' BPSD for a longer duration of time.

Little research has been carried out that specifically identifies the key elements of music therapy which contribute to its efficacy within the field of dementia. This study aims to support existing evidence highlighting the significance of using music therapy within dementia care, and, importantly, identify what elements are principally involved in producing changes in behaviour and levels of well-being. The study will also incorporate the collection of dementia residents' physiological data, specifically their Electrodermal Activity (EDA), during therapy sessions. This will be measured by recording participants' levels of skin conductance (microSiemens/cm); this is controlled by the Sympathetic Nervous System and roughly thought of as the Fight or Flight system. Many efforts have been made to explore how skin conductance indicates the levels of emotional arousal, for example, high skin conductance indicates excitement or stress; low skin conductance indicates sadness or calmness. (Poh et. al., 2010; 2012; Van Dooren et. al., 2012). The skin conductance data is proposed to help identify the key elements and observable phenomena of the videoed music therapy sessions showing reduced presentation of BPSD.

If the current study is able to identify such elements, these findings will enable future research to investigate more comprehensively how these can be transplanted into other activities to optimise their effects.

Participants will be recruited from two residential Methodist Homes, and using a cluster randomized control design, will be allocated to either the control group on intervention group. Participants in the control group will receive standard daily care for 22 weeks. Participants in the intervention group will, in addition to daily standard care, receive one session of individualised active music therapy once a week for a period of 22 weeks.

Music therapy sessions will last 30 minutes. During the session the participant will wear a 'Q-sensor' device around their wrist, which will record their skin conductance levels. Each session will be video-recorded.

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
None

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 31 participants are proposed to be recruited in total. This number comprises 16 resident participants, 14 staff participants and 1 music therapist.
  • The music therapist has already been recruited for the study and works within for the organisation's music therapy service in the two homes to be used as the research sites. The inclusion and

排除标准

  • for staff and residents are outlined below.
  • Inclusion Criteria:
  • The proposed inclusion criteria for care home residents are as follows:
  • Participants will be a resident at one of the two residential homes identified as the research sites, in one of the two house units that will be used in the project in each home.
  • Participants will have a diagnosis of dementia
  • Participants will display at least one symptom of BPSD
  • Participants will be at least 40 years of age
  • The proposed inclusion criteria for staff participants are as follows:
  • Staff participants will have at least three months' experience of working with the resident participant(s)
  • Staff participants will have an in-depth knowledge of the resident participant(s) in a 'keyworker' role
  • Exclusion Criteria:
  • The proposed exclusion criterion for care home residents is as follows:
  • Residents will be excluded if their health appears to be at a risk which raises concerns regarding their sustained involvement within the study, apparent from a general health examination with their General Practitioner
  • The proposed exclusion criteria for care staff participants is as follows:
  • Staff who have not worked with the resident participant(s) in a 'keyworker' role for at least three months.
  • Staff who would be unable to regularly work on the specific days they would be required within the home.

结局指标

主要结局

Neuropsychiatric Inventory

时间窗: At baseline in the 2 weeks prior to the music therapy intervention, then at weeks 11-12, weeks 21-22 and as a follow-up at week 27-28.

The NPI assesses the neuropsychiatric symptoms and pathology of patients with Alzheimer's disease and other neurodegenerative disorders. Ten behavioural areas (delusions, hallucinations, agitation/aggressions, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability and aberrant motor behaviour) and two neuro-vegetative areas (sleep and night-time behaviour disorders, and appetite and eating disorders) are assessed. Changes in these areas of behaviour over the two weeks prior to interview will be investigated. This project will employ the version of the NPI which has been developed for use within institutional settings (NPI-NH). The interviews will be conducted with an informed professional caregiver.

次要结局

  • Dementia Care Mapping(At baseline in the 2 weeks prior to the start of the music therapy intervention, then at weeks 11-12, weeks 21-22 and as a follow-up at weeks 27-28.)
  • Grounded theory-based interviews(The two sets of interviews will be carried out during weeks 23 and 25.)
  • Microanalysis of video recordings of sessions(Video recordings of music therapy sessions will be analysed for the duration of the 22 week intervention period, immediately after each weekly music therapy session.)

研究者

发起方
Methodist Homes for the Aged
申办方类型
Other
责任方
Sponsor

研究点 (4)

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