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Impact of Protocolizing Receptive Music Intervention on Care Refusal During Hygiene Care in Nursing Home Residents With Major Neurocognitive Disorders

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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 (40 minutes total)? * Does the music program also reduce distressing behavioral symptoms in residents? * Does it reduce the need for sedative or psychiatric medications? * Does it reduce professional burnout in caregivers who perform hygiene care? Researchers will compare three groups: * Group 1 (Control): Current practice - care staff may use MUSIC CARE© at their own discretion, as they already do * Group 2 (Music During Care): Structured use of MUSIC CARE© for 20 minutes during every hygiene care session, daily for 4 weeks * Group 3 (Music Before + During Care): Structured use of MUSIC CARE© for 20 minutes before and 20 minutes during every hygiene care session (40 minutes total), daily for 4 weeks Nursing homes (not individual residents) are randomly assigned to a group. Residents and their caregivers will: * Have their level of care refusal recorded daily for 4 weeks * Have neuropsychiatric symptoms and medication use assessed at the start, Week 4, and Week 8 * Caregivers will also complete a confidential and anonymous professional burnout questionnaire at 3 time points

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• 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

Locations
Other Locations
France
Les Jardins d'Henriville
RECRUITING
Amiens
Villa d'Épidaure Garches
RECRUITING
Garches
Villa d'Épidaure La Celle St Cloud
NOT_YET_RECRUITING
La Celle-saint-cloud
La Meulière de la Marne
NOT_YET_RECRUITING
La Ferté-sous-jouarre
Parc de Diane
RECRUITING
Nantes
Résidence La Chézalière
RECRUITING
Nantes
Résidence Les Nymphéas
RECRUITING
Pacé
Villa Bourgailh
RECRUITING
Pessac
Villa Amélie
NOT_YET_RECRUITING
Saint-rogatien
Résidence Verte Prairie
NOT_YET_RECRUITING
Salon-de-provence
Villa Tohannic
NOT_YET_RECRUITING
Vannes
Les Jardins de Leysotte
NOT_YET_RECRUITING
Villenave-d'ornon
Contact Information
Primary
Eva BRIAND
eva.briand@lna-sante.com
(0)240160161 ext +33
Time Frame
Start Date: 2025-10-30
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 60
Treatments
Active_comparator: Control: Standard Care (Current Practice)
No change to current facility care practices. MUSIC CARE©, a validated digital therapeutic tool, is available to care staff and may be used at their own discretion as per current standard practice. When a care refusal situation is identified, the resident's medical record is reviewed for potential inclusion. This arm reflects real-world standard of care in LNA Santé EHPAD facilities and serves as the comparator for protocolized intervention arms.
Experimental: Interventional 1: MUSIC CARE© During Care (20 minutes/day)
MUSIC CARE© is protocolized and prescribed in the resident's personalized care plan. A caregiver enters the resident's room with the MUSIC CARE© tablet and speaker/headphones at the time of hygiene care and programs a 20-minute personalized U-sequence throughout the care session (preparation, hygiene, installation). Music is personalized to the resident's musical preferences. Delivered daily for 4 weeks (maximum 28 sessions).
Experimental: Interventional 2: MUSIC CARE© Before and During Care (40 minutes/day)
Identical approach to Arm 2, with an additional 20-minute MUSIC CARE© session immediately before hygiene care. Caregiver visits the resident 20 minutes before care to start the first U-sequence, then programs a second U-sequence during the care session. Total: 40 minutes of protocolized music therapy per day. Delivered daily for 4 weeks (maximum 56 music sessions).
Related Therapeutic Areas
Sponsors
Leads: LNA SANTE

This content was sourced from clinicaltrials.gov