Clinical trial NCT02670993: Support by Singing Sessions on Physical and Moral Pain : Assessment of Its Effectiveness in Alzheimer's Disease
Official title: Support by Singing Sessions on Physical and Moral Pain : Assessment of Its Effectiveness in Alzheimer's Disease. Multicenter Study LACME
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2016-02-02
Enrollment: 59
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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".

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Score at the EVS = simplified visual scale
timeFrame: Month 1
Secondary outcomes:
measure: Score at the EN (digital scale) scale
timeFrame: Month 1
measure: Score at the BPI (Brief Pain Inventory) scale : Brief pain Inventory
timeFrame: Month 1
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices civils de Lyon
city: Saint Etienne
country: France
facility: Chu Saint Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: ROUCH Isabelle, MD
role: PRINCIPAL_INVESTIGATOR
References: