Protocolized Receptive Music Intervention to Reduce Care Refusal in Nursing Home Residents With Major Neurocognitive Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLNA SANTE
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Uncompensated hearing loss with sensory isolation (unable to benefit from music therapy)
Documented end-of-life status in the medical record
Adult (18 years of age or older)
Working in the care unit of an enrolled resident and performing hygiene/nursing care (bathing)
Trial design
Design model
Parallel
Treatments tested in this trial
Receptive music therapy
DeviceMUSIC 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 Nursing Home Care
Other interventionStandard 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.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Control: Standard Care (Current Practice)Active comparator 1 intervention
Group B: Interventional 1: MUSIC CARE© During Care (20 minutes/day)Experimental treatment 1 intervention
Group C: Interventional 2: MUSIC CARE© Before and During Care (40 minutes/day)Experimental treatment 1 intervention
Trial outcomes
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
Time frame
Daily from Day 1 to Day 28 (Weeks 1-4)Secondary outcomes
1
Daily Duration of Hygiene Care Session Over 4 Weeks (Minutes)
Total duration of each hygiene care session recorded daily by caregivers, including negotiation time and care time (preparation, hygiene, installation). Assessed in minutes per session. Lower duration may indicate improved care cooperation or efficiency.
Time frame
Daily from Day 1 to Day 28 (Weeks 1-4)2
Change from Baseline in Neuropsychiatric Symptoms as Assessed by the Neuropsychiatric Inventory - Nursing Staff Version (NPI-ES) at Week 4
The NPI-ES assesses 12 behavioral and neurovegetative domains in dementia patients. Each domain score = Frequency (1-4, or 0 if absent) × Severity (1-3, or 0 if absent). Total behavioral score (10 domains): 0 to 120; higher score = more severe neuropsychiatric symptoms. A professional burden subscale (0-5 per domain) is assessed separately.
Time frame
Baseline (Day 0) and Week 43
Change from Baseline in Neuropsychiatric Symptoms as Assessed by the Neuropsychiatric Inventory - Nursing Staff Version (NPI-ES) at Week 8
The NPI-ES assesses 12 behavioral and neurovegetative domains. Total behavioral score (10 domains): 0 to 120; higher score = more severe neuropsychiatric symptoms. Week 8 assessment measures persistence of effect 4 weeks after the end of the protocolized intervention period.
Time frame
Baseline (Day 0) and Week 84
Change from Baseline in Monthly Psychotropic Medication Use at Week 4
Monthly consumption of psychotropic medications (recorded by category: benzodiazepines, antidepressants, neuroleptics, hypnotics) from resident's medical records, both as standing prescriptions and as-needed use. Assessed at Week 4 for the interval J0-S4. Lower use reflects potential reduction in pharmacological management of BPSD.
Time frame
4 weeks prior to Baseline (Day 0) and Weeks 1-4 (J0 to S4) Source ClinicalTrials.gov