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Completed

NCT Number: NCT02670993

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

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospices civils de Lyon, Lyon, France

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About this study

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".

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Singing sessions.

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.

Painting sessions.

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

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

Acronym: LACME

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 2, 2016
Registry last updated
Sep 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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