Protocolized Receptive Music Intervention to Reduce Care Refusal in Nursing Home Residents With Major Neurocognitive Disorders
OPPOZIC'
Impact of Protocolizing Receptive Music Intervention on Care Refusal During Hygiene Care in Nursing Home Residents With Major Neurocognitive Disorders
1 other identifier
interventional
60
1 country
12
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2025
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 30, 2025
CompletedFirst Submitted
Initial submission to the registry
July 23, 2026
CompletedFirst Posted
Study publicly available on registry
July 28, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
July 28, 2026
July 1, 2026
1.7 years
July 23, 2026
July 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Daily Degree of Hygiene Care Acceptance or Refusal as Assessed by a 4-Level Ordinal Scale Over 4 Weeks
A 4-category ordinal scale recorded daily by caregivers: 1 = No refusal (complete care without negotiation); 2 = Complete care with negotiation; 3 = Partial care with negotiation; 4 = Complete refusal/failure (including paradoxical anxiety or emotional re-activation triggered by music). Score range: 1 to 4; lower score = better care acceptance. Category 4 is defined as refusal/failure in all analyses
Daily from Day 1 to Day 28 (Weeks 1-4)
Secondary Outcomes (9)
Daily Duration of Hygiene Care Session Over 4 Weeks (Minutes)
Daily from Day 1 to Day 28 (Weeks 1-4)
Change from Baseline in Neuropsychiatric Symptoms as Assessed by the Neuropsychiatric Inventory - Nursing Staff Version (NPI-ES) at Week 4
Baseline (Day 0) and Week 4
Change from Baseline in Neuropsychiatric Symptoms as Assessed by the Neuropsychiatric Inventory - Nursing Staff Version (NPI-ES) at Week 8
Baseline (Day 0) and Week 8
Change from Baseline in Monthly Psychotropic Medication Use at Week 4
4 weeks prior to Baseline (Day 0) and Weeks 1-4 (J0 to S4)
Change from Baseline in Monthly Psychotropic Medication Use at Week 8
Weeks 5-8 (S4 to S8)
- +4 more secondary outcomes
Study Arms (3)
Control: Standard Care (Current Practice)
ACTIVE COMPARATORNo 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.
Interventional 1: MUSIC CARE© During Care (20 minutes/day)
EXPERIMENTALMUSIC 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).
Interventional 2: MUSIC CARE© Before and During Care (40 minutes/day)
EXPERIMENTALIdentical 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).
Interventions
MUSIC CARE© is a CE-marked Class 1 Medical Device delivering personalized digital receptive music therapy. Algorithmically composed music sequences follow a standardized "U-sequence" protocol (induction → relaxation → wake phases). Sequences (58 available, 15-90 min) are exclusively instrumental, without lyrics. Personalized to each resident's musical preferences. Delivered via tablet and speaker/headphones. Dosing: 20 min/day during care (Arm 2) or 20 min before + 20 min during care (Arm 3) for 4 weeks.
Standard geriatric nursing care as practiced in LNA Santé EHPAD facilities, including medical monitoring, nursing care, hygiene assistance, nutrition support, social activities, and non-pharmacological approaches as clinically indicated. In the control arm, MUSIC CARE© may be used at caregiver discretion (current standard practice) but is not protocolized.
Eligibility Criteria
You may qualify if:
- 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)
- Resident and/or their legal representative or trusted person has given written consent to participate
- Affiliated to a French social security scheme
You may not qualify if:
- Uncompensated hearing loss with sensory isolation (unable to benefit from music therapy)
- Documented end-of-life status in the medical record
- CAREGIVER ELIGIBILITY
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LNA SANTElead
Study Sites (12)
Les Jardins d'Henriville
Amiens, 80000, France
Villa d'Épidaure Garches
Garches, 92380, France
Villa d'Épidaure La Celle St Cloud
La Celle-Saint-Cloud, 78170, France
La Meulière de la Marne
La Ferté-sous-Jouarre, 77260, France
Résidence La Chézalière
Nantes, 44100, France
Parc de Diane
Nantes, 44200, France
Résidence Les Nymphéas
Pacé, 35740, France
Villa Bourgailh
Pessac, 33600, France
Villa Amélie
Saint-Rogatien, 17220, France
Résidence Verte Prairie
Salon-de-Provence, 13300, France
Villa Tohannic
Vannes, 56000, France
Les Jardins de Leysotte
Villenave-d'Ornon, 33140, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nolwenn DELARUE, DR
Les Nymphéas - LNA Santé
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2026
First Posted
July 28, 2026
Study Start
October 30, 2025
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
July 28, 2026
Record last verified: 2026-07