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

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ClinicalTrials.gov Identifier: NCT02670993
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : September 20, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Behavioral: Singing sessions. Behavioral: Painting sessions. Not Applicable

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".

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Support by Singing Sessions on Physical and Moral Pain : Assessment of Its Effectiveness in Alzheimer's Disease. Multicenter Study LACME
Study Start Date : January 2016
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Control group : Singing sessions.
Patients will participate to singing working sessions. They will continue to take their usual treatments during the study period.
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.

Active Comparator: Control group : Painting sessions.
Patients will continue to participate to painting work sessions, and to take their usual treatments during the study.
Behavioral: 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.




Primary Outcome Measures :
  1. Score at the EVS = simplified visual scale [ Time Frame: 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 :
  1. Score at the EN (digital scale) scale [ Time Frame: 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.

  2. Score at the BPI (Brief Pain Inventory) scale : Brief pain Inventory [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02670993


Locations
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France
Hospices civils de Lyon
Lyon, France, 69000
Chu Saint Etienne
Saint Etienne, France, 42100
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: ROUCH Isabelle, MD CHU SAINT ETIENNE
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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02670993    
Other Study ID Numbers: 1508071
2015-A01404-45 ( Other Identifier: ANSM )
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders