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Protocolized Receptive Music Intervention to Reduce Care Refusal in Nursing Home Residents With Major Neurocognitive Disorders

RecruitingNAAges 18 Years - anyAllLNA SANTE
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In plain words

What the trial is, and whether it could suit you

The goal of this randomized study is to find out whether using a structured, protocolized music program (MUSIC CARE©) during daily hygiene care can reduce care refusal in older adults with dementia (memory and thinking conditions) who live in nursing homes (EHPADs). What is "care refusal"? Care refusal (also called resistance to care) happens when a person with dementia refuses or becomes distressed during everyday care activities such as bathing, dressing, or taking medications. It is a very common situation in nursing homes that can be stressful for both residents and care staff. The main questions this study aims to answer are: * Can a structured, daily music program reduce care refusal during bathing and hygiene care compared to current practice? * Does using music for 20 minutes during the care session work as well as - or differently from - using it both before and during care (

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
RESIDENT ELIGIBILITY Inclusion Criteria: * Living in a LNA Santé EHPAD (nursing home) as a permanent resident for at least 3 months * Diagnosed Alzheimer's disease or a related disorder, or confirmed cognitive decline shown by a Mini-Mental State Examination (MMSE - a short memory and thinking test) score of 24 or less within the past 12 months (including cases where the MMSE cannot be administered due to severe cognitive impairment) * Showing care refusal behavior, defined as an Agitation/Aggression item score on the NPI-ES scale (frequency × severity) greater than or equal to 4 at the time of inclusion * Resident and/or their legal representative or trusted person has given written consent to participate * Affiliated to a French social security scheme Exclusion Criteria: * Uncompensated hearing loss with sensory isolation (unable to benefit from music therapy) * Documented end-of-life status in the medical record CAREGIVER ELIGIBILITY Inclusion Criteria (Caregivers): * Adult (18 years of age or older) * Working in the care unit of an enrolled resident and performing hygiene/nursing care (bathing) * Able to read and write French * Affiliated to a French social security scheme * Has given written consent to participate Exclusion Criteria (Caregivers): * Employment contract shorter than the resident's 3-month study follow-up period (i.e., unable to complete all 3 caregiver assessments) * Unable to provide informed consent to participate * Under legal protection as defined by Article 1121-8 of the French Public Health Code (under legal guardianship or deprived of liberty) * Not affiliated to a French social security scheme
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What it tests

  • Receptive music therapy
  • Standard Nursing Home Care
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Where

12 sites
Les Jardins d'Henriville
Amiens, France
Villa d'Épidaure Garches
Garches, France
Villa d'Épidaure La Celle St Cloud
La Celle-Saint-Cloud, France
La Meulière de la Marne
La Ferté-sous-Jouarre, France
Résidence La Chézalière
Nantes, France
Parc de Diane
Nantes, France
Résidence Les Nymphéas
Pacé, France
Villa Bourgailh
Pessac, France

…and 4 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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