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

NCT ID: NCT02670993

Last Updated: 2016-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-06-30

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".

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Control group : Singing sessions.

Patients will participate to singing working sessions. They will continue to take their usual treatments during the study period.

Group Type: EXPERIMENTAL

Singing sessions.

Intervention Type: BEHAVIORAL

Patients will be in singing work groups, and will participate to these sessions during 12 weeks, with one session per week of 2 hours.

Control group : Painting sessions.

Patients will continue to participate to painting work sessions, and to take their usual treatments during the study.

Group Type: ACTIVE_COMPARATOR

Painting sessions.

Intervention Type: BEHAVIORAL

Patients will be in painting groups, they will participate to this work session during 12 weeks, with one session of 2 hours per week.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ROUCH Isabelle, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

Hospices civils de Lyon

Lyon, , France

Chu Saint Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

2015-A01404-45

Identifier Type: OTHER

Identifier Source: secondary_id

1508071

Identifier Type: -

Identifier Source: org_study_id