Support by Singing Sessions on Physical and Moral Pain : Assessment of Its Effectiveness in Alzheimer's Disease

Alzheimer's Disease Clinical Trial

— LACME  

Official title:

Support by Singing Sessions on Physical and Moral Pain : Assessment of Its Effectiveness in Alzheimer's Disease. Multicenter Study LACME

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02670993
• Other study ID #: 1508071
• Secondary ID: 2015-A01404-45
• Status: Completed
• Phase: N/A
• First received: January 25, 2016
• Last updated: September 19, 2016
• Start date: January 2016
• Est. completion date: June 2016

Study information

• Verified date: September 2016
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Behavioral:
• Singing sessions.
Patients will be in singing work groups, and will participate to these sessions during 12 weeks, with one session per week of 2 hours.
• Painting sessions.
Patients will be in painting groups, they will participate to this work session during 12 weeks, with one session of 2 hours per week.

Locations

Country	Name	City	State
France	Hospices civils de Lyon	Lyon
France	Chu Saint Etienne	Saint Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score at the EVS = simplified visual scale	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.	Month 1	No
Secondary	Score at the EN (digital scale) scale	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.	Month 1	No
Secondary	Score at the BPI (Brief Pain Inventory) scale : Brief pain Inventory	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.	Month 1	No