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

September 19, 2016 updated by: Centre Hospitalier Universitaire de Saint Etienne

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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".

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69000
        • Hospices Civils de Lyon
      • Saint Etienne, France, 42100
        • CHU Saint Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Month 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Month 1
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.
Month 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: ROUCH Isabelle, MD, CHU Saint Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

January 25, 2016

First Submitted That Met QC Criteria

January 28, 2016

First Posted (Estimate)

February 2, 2016

Study Record Updates

Last Update Posted (Estimate)

September 20, 2016

Last Update Submitted That Met QC Criteria

September 19, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1508071
  • 2015-A01404-45 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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