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

Condition(s) studied

Investigational drug(s) / intervention(s)

Receptive music therapy: 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 Nursing Home Care: 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.

Study 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

Primary outcome measure(s)

• Daily Degree of Hygiene Care Acceptance or Refusal as Assessed by a 4-Level Ordinal Scale Over 4 Weeks — Daily from Day 1 to Day 28 (Weeks 1-4)
  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

Trial sites (12)

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