Impact of Protocolizing Receptive Music Intervention on Care Refusal During Hygiene Care in Nursing Home Residents With Major Neurocognitive Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 12
- 主要终点
- Daily Degree of Hygiene Care Acceptance or Refusal as Assessed by a 4-Level Ordinal Scale Over 4 Weeks
研究概览
简要总结
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
详细描述
- Background and Rationale
Behavioral and psychological symptoms of dementia (BPSD) are among the most challenging aspects of dementia care, affecting up to 90% of individuals at some point in their disease course. While apathy, anxiety, and depression are the most common BPSD, agitation, aggression, and opposition to care - particularly during direct nursing care activities (bathing, dressing, medication administration) - are frequently reported by both family and professional caregivers.
Care refusal (also termed resistance to care) is defined as any verbal or non-verbal attitude of refusal to accept care, food, hygiene activities, or participation in daily activities. It interferes directly with caregivers' ability to perform activities of daily living assistance, such as bathing, dressing, meal support, and medication administration. It can be misinterpreted as aggression and may lead to inappropriate therapeutic escalation, including physical restraint or psychotropic medication prescription, both of which carry significant adverse effects. In all cases, care refusal should be interpreted as a genuine expression of refusal, even when cognitive autonomy is impaired.
Non-pharmacological interventions (NPIs) are recommended as first-line approaches for BPSD management by French health authorities (HAS) and international expert bodies. Among NPIs, music therapy is one of the best-evidenced techniques, with demonstrated effects on apathy, anxiety, depression, cognitive and emotional competencies, and pain. However, its potential in reducing care refusal specifically has received limited study attention. 2. Rationale for the Intervention
MUSIC CARE© is a validated clinical digital therapy tool (Class 1 Medical Device, CE-marked), developed in France, that uses algorithmically generated personalized music sequences based on the principles of hypnoanalgesia. It follows a standardized "U-sequence" protocol with three phases: an induction phase (stimulating, gradually slowing), a relaxation phase (minimal instrumentation, slow tempo), and a wake phase (gradual return toward initial parameters). Sequences are exclusively composed for MUSIC CARE©, are instrumental, and are free of lyrics to minimize the risk of emotional re-activation through familiar melodies. The tool has a catalogue of 58 sequences across a wide variety of musical styles and can be adapted to individual musical preferences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Daily Degree of Hygiene Care Acceptance or Refusal as Assessed by a 4-Level Ordinal Scale Over 4 Weeks
时间窗: 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
次要结局
- 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))
- Change from Baseline in Caregiver Professional Burnout as Assessed by the Maslach Burnout Inventory (MBI) at Week 4(Baseline (Day 0) and Week 4)
- Change from Baseline in Caregiver Professional Burnout as Assessed by the Maslach Burnout Inventory (MBI) at Week 8(Baseline (Day 0) and Week 8)
- Rate of MUSIC CARE© Protocolization as Measured by Number of Caregivers Using the Intervention and Number of Sessions Completed at Week 4(Week 4)
- Rate of MUSIC CARE© Protocolization as Measured by Number of Caregivers Using the Intervention and Number of Sessions Completed at Week 8(Week 8)
