Support by Singing Sessions on Physical and Moral Pain : Assessment of Its Effectiveness in Alzheimer's Disease
- Conditions
- Alzheimer's Disease
- Interventions
- Behavioral: Singing sessions.Behavioral: Painting sessions.
- Registration Number
- NCT02670993
- Brief Summary
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.
- Detailed Description
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".
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 59
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group : Singing sessions. Singing sessions. Patients will participate to singing working sessions. They will continue to take their usual treatments during the study period. Control group : Painting sessions. Painting sessions. Patients will continue to participate to painting work sessions, and to take their usual treatments during the study.
- Primary Outcome Measures
Name Time Method Score at the EVS = simplified visual scale 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.
- Secondary Outcome Measures
Name Time Method Score at the BPI (Brief Pain Inventory) scale : Brief pain Inventory 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.
Score at the EN (digital scale) scale 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.
Trial Locations
- Locations (2)
Chu Saint Etienne
🇫🇷Saint Etienne, France
Hospices civils de Lyon
🇫🇷Lyon, France