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临床试验/NCT01123993
NCT01123993已完成3 期

The Effect of Thai Traditional Music on Cognitive Function, Psychological Health and Quality of Sleep Among Thai Older Individuals With Dementia.

Phramongkutklao College of Medicine and Hospital4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年2月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
60
试验地点
4
主要终点
Depression

研究概览

简要总结

To determine the effect of Thai traditional music on cognitive function, psychological health and quality of sleep among Thai older individuals with dementia.

详细描述

Dementia, regardless of its cause, has been recognized to be one of the most important and common problems among the elderly worldwide. The prevalence of dementia has been increasing gradually throughout the world. It is associated with medical and psychological consequences, especially in the advanced stage of the condition. Medications for dementia, specifically, acetylcholine esterase inhibitors, have proven efficacy but variable individual response. They are very expensive and stress families and insurance payers. Dementia and its neuropsychiatric co-morbidities effects not only individual patients, but also family members and care givers as it stresses interpersonal relationships, increases the need for personal care, nursing home placement, and the use of neuropsychiatric medications. Any new approach to improve cognitive function, behavior, mood and sleep quality among demented individuals therefore could have far reaching benefits for patients, care givers, financially responsive parties, and the country as a whole.

There are several studies focusing on the non-pharmacologic approaches to care of the demented. The objectives were to reduce reliance on prescribed medications with these adjunctive therapies. One of the interesting non-drug trials was about music therapy. It was found that music could improve behavioral and social functions among individual demented patients. However, the methodology of each music study varied considerably. To our knowledge, there has been no music study in dementia performed in Thailand using our unique Thai traditional music. We therefore aim to study this non-pharmacologic approach in Thai demented individuals using Thai traditional music. We hypothesized that regular listening to Thai traditional music will improve cognitive function, activities of daily living, mood, behavior and sleep quality in Thai demented patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Age > 60 years
  • Diagnosed with Alzheimer's disease, vascular dementia or mixed dementia by ICD-10
  • No change in neuropsychiatric drugs for at least 4-week before and 8-week during the study
  • CD player available at home
  • Patient and care giver consent to study

排除标准

  • Severe depression requiring aggressive treatment or hospitalization
  • Dementia with Lewy body, multisystem atrophy
  • Treatable dementia
  • Active medical problems
  • Profound hearing loss

结局指标

主要结局

Depression

时间窗: 4-week after regularly listening to the music for 28 days

Using Thai Geriatric Depression Scale (TGDS)

Activities of Daily Living

时间窗: 4-week after music

using AD Cooperative Study Activities of Daily Living Inventory (ADCS/ADL)

Behavior

时间窗: 4-week after music

Using Behavioral pathology in Alzheimer's Disease Rating Scale (BEHAVE AD)

Sleep quality

时间窗: 4-week after music

Using Pittsburgh Sleep Quality Index (PSQI)

次要结局

  • reduction of the care giver's stress and burden(4-week after intervention)

研究者

发起方
Phramongkutklao College of Medicine and Hospital
申办方类型
Other

研究点 (4)

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