Music Therapy and Psycho-behavioral Disorders in the Elderly Population (DEMUse)
Primary Purpose
Behavioral Disorder, Music Therapy
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Music therapy session via tools validated by MUSIC CARE
Sponsored by
About this trial
This is an interventional supportive care trial for Behavioral Disorder
Eligibility Criteria
Inclusion Criteria:
- Patients over the age of 60 present in the reinforced hospital unit during the study period
- Patients over 60 years hospitalized in follow-up care and rehabilitation with behavioral disorders in the context of a neurocognitive disorder
Exclusion Criteria:
- Unpaired deafness
- Refusal to participate
Sites / Locations
- Hôpital Pierre GarraudRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
UHR and SRH
Arm Description
All patients over the age of 60 present in the UHR and hospitalized in SRH with behavioral disorders in the context of a neurocognitive disorder
Outcomes
Primary Outcome Measures
Evolution of the NeuroPsychiatric Inventory (NPI) scale
The improvement in psycho-behavioral symptoms will be assessed by the NPI score provided by the MUSIC CARE application carried out by a caregiver.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04702594
Brief Title
Music Therapy and Psycho-behavioral Disorders in the Elderly Population
Acronym
DEMUse
Official Title
Impact of Music Therapy on Psycho-behavioral Disorders of the Elderly Suffering From Neuro-cognitive Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 18, 2021 (Actual)
Primary Completion Date
August 18, 2021 (Anticipated)
Study Completion Date
August 18, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Since the 1990s, neuroscience, with functional MRI, has made it possible to understand the beneficial neurophysiological effect of music on man and his brain. They have shown that music stimulates brain plasticity and contributes to the reorganization of the affected neural circuits. The concept of cerebral plasticity and cerebral symphony have thus been developed. In March 2008, the HAS (High Authority for Health) proposed in its recommendations good practices concerning the management of neurodegenerative diseases that "Music therapy, aromatherapy, multisensory stimulation ... could improve certain of behavior's aspects ". Music has shown that memory capacity can remain present in people with Alzheimer's disease even in the advanced stages. Music also improves the well-being of patients with Alzheimer's or mixed dementia living in institutions and reduces the suffering of caregivers. It improves communication with others, including those who have lost the usual codes of communication and improves the quality of sleep of elderly people living in institutions.
However, although musical interventions have recently gained popularity as a non-pharmacological treatment for dementia, the scientific evidence warrants further research.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavioral Disorder, Music Therapy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
UHR and SRH
Arm Type
Experimental
Arm Description
All patients over the age of 60 present in the UHR and hospitalized in SRH with behavioral disorders in the context of a neurocognitive disorder
Intervention Type
Behavioral
Intervention Name(s)
Music therapy session via tools validated by MUSIC CARE
Intervention Description
Use of the MUSICARE tool, a digital space allowing access to different validated methods of music therapy. Music listening times are offered to patients with cognitive impairment with psycho-behavioral symptoms. The sessions are individual or group performed by a psychomotor therapist in UHR and volunteer caregivers trained in SRH. The sessions last on average 20-30min.
Primary Outcome Measure Information:
Title
Evolution of the NeuroPsychiatric Inventory (NPI) scale
Description
The improvement in psycho-behavioral symptoms will be assessed by the NPI score provided by the MUSIC CARE application carried out by a caregiver.
Time Frame
Baseline, once a week during study participation and at the end of the patient's participation in the study (1 month after inclusion)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients over the age of 60 present in the reinforced hospital unit during the study period
Patients over 60 years hospitalized in follow-up care and rehabilitation with behavioral disorders in the context of a neurocognitive disorder
Exclusion Criteria:
Unpaired deafness
Refusal to participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne FRELY, MD
Phone
04.72.16.71.41
Email
anne.frely@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Blandine DE-LA-GASTINE, MD
Phone
04.72.16.71.14
Email
blandine.de-la-gastine@chu-lyon.fr
Facility Information:
Facility Name
Hôpital Pierre Garraud
City
Lyon
ZIP/Postal Code
69005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne FRELY,, PH
Phone
04.72.16.71.41
Email
anne.frely@chu-lyon.fr
12. IPD Sharing Statement
Learn more about this trial
Music Therapy and Psycho-behavioral Disorders in the Elderly Population
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