Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02670993
Acronym
LACME
Enrollment
59
Registered
2016-02-02
Start date
2016-01-31
Completion date
2016-06-30
Last updated
2016-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

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.

Interventions

BEHAVIORALSinging 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.

BEHAVIORALPainting 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.

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Score at the EVS = simplified visual scaleMonth 1To 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

MeasureTime frameDescription
Score at the EN (digital scale) scaleMonth 1To 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 BPI (Brief Pain Inventory) scale : Brief pain InventoryMonth 1To 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026