Support by Singing Sessions on Physical and Moral Pain : Assessment of Its Effectiveness in Alzheimer's Disease. Multicenter Study LACME
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 4
- 主要终点
- Score at the EVS = simplified visual scale
研究概览
简要总结
Alzheimer Disease (AD), characterized by cognitive and psycho-behavioral troubles, concerns essentially 65 years old and older patients. Antalgic and psychotropic treatments have adverse effects in old people, and have to be used carefully. To improve the pain support and limit the drug consumption, it is possible to perform therapies without drugs. Among them, musical intervention represents an interesting complementary support, to deal with physical and moral pain in AD.
详细描述
Alzheimer Disease (AD), characterized by cognitive and psycho-behavioral troubles, concerns essentially 65 years old and older patients. At this age, comorbidities are frequent and numerous, and often linked to pain. The prevalence is comprised between 40 and 85% according to different studies. Antalgic and psychotropic treatments have adverse effects in old people, and have to be used carefully. To improve the pain support and limit the drug consumption, it is possible to perform therapies without drugs. Among them, musical intervention represents an interesting complementary support, to deal with physical and moral pain in AD.
The primary outcome is to evaluate the singing support on physical pain, by comparison with a control activity : "painting session".
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •Patients 60 years old and older, fulfilling the diagnostic criteria for Alzheimer's disease to a mild dementia stage, or mild cognitive impairment
- •Delay of at least one month between the diagnosis and the early work sessions
- •If use of psychotropic drugs, they must be stabilized for 3 month
- •If analgesics consumption level 2 or 3 they must be stabilized for 1 month
- •With a score greater than or equal to 22 on the simplified visual scale (EVS) pain.
- •Visual capabilities , auditory and oral or written expression in French language sufficient for conducting clinical and neuropsychological evaluations;
- •MMSE > 20
- •Patient affiliated or entitled to a social security scheme
排除标准
- •Patient with a different etiology of cognitive disorder that of Alzheimer's disease
- •Patients with severe disease, progressive or unstable nature which may interfere with the evaluation variables
- •Patient with blindness or deafness could compromise its assessment
- •Patient under guardianship
结局指标
主要结局
Score at the EVS = simplified visual scale
时间窗: Month 1
To evaluate the efficacy of the singing sessions on pain in Alzheimer's Disease patients (beginning stage), by comparison with a control activity (painting), on pain intensity.
次要结局
- Score at the BPI (Brief Pain Inventory) scale : Brief pain Inventory(Month 1)
- Score at the EN (digital scale) scale(Month 1)