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

23 luglio 2026 aggiornato da: LNA SANTE

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

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

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

  1. 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.

    MUSIC CARE© has been deployed across LNA Santé establishments since 2021. Clinical observation suggested that while the tool is available, its use in care refusal situations remains inconsistent and practitioner-dependent. Based on scientific literature indicating that psychosocial interventions require structured, protocolized implementation (at least twice weekly, minimum 12 sessions) to demonstrate measurable effects on BPSD, this study was designed to evaluate the impact of formalizing MUSIC CARE© use as a care prescription during hygiene situations.

  3. Study Design

    OPPOZIC' is a prospective, multicenter, cluster-randomized, open-label study conducted across 15 EHPAD (nursing homes) within the LNA Santé group in France.

    Cluster randomization is performed at the EHPAD level: all residents from a given EHPAD are assigned to the same arm (Control, Interventional 1, or Interventional 2). This approach was chosen to ensure feasibility of uniform staff practice within each facility and to enable assessment of protocolization effects at the facility level. Randomization is centralized by LNA Santé before the first resident is enrolled in each facility.

    The study involves two populations:

    - Residents: elderly residents with major neurocognitive disorders presenting care refusal during hygiene care (primary population; n=60)

    - Caregivers (soignants): nursing and care staff performing hygiene care for enrolled residents (secondary population; approximately 10-30 per EHPAD, for a total estimated n=150-450) The study is open-label: blinding is not feasible for a behavioral/digital therapeutic intervention.

  4. Intervention Description by Arm

    Arm A - Control: Standard Care (Current Practice) No change to current facility care practices is required. MUSIC CARE© is available to care staff and may be used at their own clinical judgment and discretion, as is currently practiced in LNA Santé facilities. When a care refusal situation is identified, the resident's medical file is reviewed for potential inclusion. This arm reflects real-world current standard of care and serves as the comparator for the protocolized intervention arms.

    Arm B - Interventional 1: Protocolized MUSIC CARE© During Hygiene Care (20 minutes) MUSIC CARE© is protocolized and formally integrated into the resident's personalized care plan (equivalent to a medication prescription). When a care refusal situation is identified, the care team implements a structured MUSIC CARE© intervention during hygiene care. A caregiver enters the resident's room with the MUSIC CARE© tablet and speaker/headphones at the time of care. A 20-minute U-sequence, personalized to the resident's musical preferences, is programmed and played throughout the care session (preparation, hygiene care, installation). This protocol is applied daily for 4 weeks.

    Arm C - Interventional 2: Protocolized MUSIC CARE© Before and During Hygiene Care (40 minutes total) The approach is identical to Arm B, with the addition of a 20-minute music session delivered before the hygiene care. The caregiver visits the resident 20 minutes before the care session to start the first U-sequence, then programs a second U-sequence during the care itself. Total daily music intervention: 40 minutes. This protocol is applied daily for 4 weeks.

  5. Standard Care Program

    All arms continue to receive standard geriatric nursing care within the EHPAD (medical monitoring, nutritional support, social activities, other non-pharmacological approaches as clinically indicated). MUSIC CARE© use in control arm facilities is not prohibited; it is simply not protocolized.

  6. Visit Schedule and Procedures

    Resident pathway:

    • Pre-selection (Day -7) Eligibility check; information letters provided to resident and/or representative; 7-day reflection period
    • Inclusion / Baseline (Day 0) Written informed consent; demographics; MMSE; NPI-ES (multidisciplinary team); psychotropic medications (last 4 weeks); start of care refusal and duration tracking
    • Weeks 1-4 (S1-S4) - daily Degree of care acceptance/refusal (4-level scale); duration of hygiene care session; adverse event monitoring
    • Follow-up assessment (Week 4 ± 3 days) NPI-ES; psychotropic medications (J0→S4); protocolization data (sessions completed, staff involved)
    • End-of-study assessment (Week 8) NPI-ES; psychotropic medications (S4→S8); adverse events

    Caregiver pathway:

    - Pre-selection (Day -7) Information letter provided; 7-day reflection period Inclusion (Day 0) Written informed consent; Maslach Burnout Inventory (MBI) - anonymous

    • Week 4 (S4) Maslach Burnout Inventory (anonymous)
    • Week 8 (S8) Maslach Burnout Inventory (anonymous)
  7. Assessment Tools

4-Level Ordinal Care Acceptance/Refusal Scale - Primary Outcome Measure

A structured 4-category observational scale recorded daily by caregivers during hygiene care:

  • Category 1: No refusal - complete care performed without negotiation
  • Category 2: Complete care performed with negotiation
  • Category 3: Partial care performed with negotiation
  • Category 4: Complete refusal or failure (including paradoxical anxiety activation or emotional re-activation triggered by music) Score range: 1 (best) to 4 (worst). Category 4 is treated as complete refusal/failure in all statistical analyses (per CPP recommendation). Lower score = better care acceptance. Assessed daily, Days 1-28.

NPI-ES (Neuropsychiatric Inventory - Nursing Staff version) The NPI-ES is a validated caregiver-report instrument assessing 12 behavioral and neurovegetative domains in patients with dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, euphoria, apathy/indifference, disinhibition, irritability/emotional lability, aberrant motor behavior, sleep, and appetite/eating disorders. 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 caregiver professional burden subscale (0-5 per domain) is assessed separately and is not included in the total score.

Maslach Burnout Inventory (MBI) - Caregiver Outcome

The MBI is a 22-item self-report questionnaire assessing professional burnout, completed anonymously by caregivers. Each item rated on a frequency scale (0 = never to 6 = daily). Three subscales:

- Emotional Exhaustion (9 items, total 0-54): score <17 = low burnout; 18-29 = -moderate; ≥30 = high. Higher = greater burnout.

  • Depersonalization (5 items, total 0-30): score <5 = low burnout; 6-11 = moderate; ≥12 = high. Higher = greater burnout.

  • Personal Accomplishment (8 items, total 0-48): score ≥40 = low burnout; 34-39 = moderate; ≤33 = high. Higher = LESS burnout (reversed direction for this subscale).

    (8) Statistical Analysis Plan Statistical analyses will be performed using R software (v4.3.2 or later) by the LNA Santé Research Support Unit. All tests are two-sided at a global alpha of 5%. p < 0.05 is considered statistically significant. 95% confidence intervals are reported throughout.

  • Descriptive statistics: Continuous variables described as mean ± SD (with normality assessment) and median [Q1-Q3, min-max]. Categorical/discrete variables as n (%).
  • Primary outcome - care acceptance/refusal scale (ordinal, 4 categories):

The primary outcome (score 1-4) may be analyzed as a discrete variable using Pearson's Chi-square or Fisher's exact test. A Poisson regression (or logistic regression focusing on score 4 = refusal/failure) will estimate odds ratios between the three randomization groups. Category 4 (paradoxical reaction/anxiety) is treated as complete refusal/failure in all analyses (per CPP requirement).

- Between-group comparisons (3 arms): ANOVA or Kruskal-Wallis for continuous variables; Chi-square or Fisher's exact test for categorical variables. Pairwise comparisons: t-test or Mann-Whitney U, Chi-square; no p-value correction given exploratory nature.

- Temporal evolution (repeated measures at J0, S4, S8): Mixed-effects models with patient/resident as random effect, using the most appropriate regression (linear, logistic, or Poisson). NPI-ES total and subscale scores, Maslach subscale scores, and psychotropic medication use will be analyzed at each time point.

- Exploratory analyses: Subgroup analyses if sample sizes allow. Multivariate models if confounders are identified.

- Sample size: 60 residents (4/center × 15 centers) over 18 months. Defined based on inclusion potential, given the exploratory nature of the study. Caregiver participation: estimated 10-30 per EHPAD (total ~150-450).

(9) Benefit/Risk Analysis

Expected benefits for residents: Reduction in care refusal and distress during hygiene care; possible reduction in psychotropic medication use; improved quality of care interactions.

Expected benefits for caregivers: Facilitated hygiene care; improved caregiver-resident relationship; reduced professional burnout; enhanced sense of professional accomplishment.

Expected benefits for LNA Santé: Evidence-based protocol for MUSIC CARE© as a non-pharmacological care prescription; standardized clinical practice.

Identified risks (minimal):

- Paradoxical anxiety activation or emotional re-activation (triggered by music associated with a past trauma): managed by study exit as per principal investigator decision; treated as complete refusal (score 4) in statistical analyses per CPP requirement.

This study is classified under Loi Jardé, Category 2 (minimal risk and constraints). No ANSM authorization is required.

Tipo di studio

Interventistico

Iscrizione (Stimato)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Francia
      • Amiens, Francia, 80000
        • Reclutamento
        • Les Jardins d'Henriville
        • Contatto:
        • Investigatore principale:
          • Claire MARTEIN, DR
      • Garches, Francia, 92380
        • Reclutamento
        • Villa d'Épidaure Garches
        • Contatto:
        • Investigatore principale:
          • Merryl ZERBIB, DR
      • La Celle-Saint-Cloud, Francia, 78170
        • Non ancora reclutamento
        • Villa d'Épidaure La Celle St Cloud
        • Contatto:
        • Investigatore principale:
          • Anne JURET, DR
      • La Ferté-sous-Jouarre, Francia, 77260
        • Non ancora reclutamento
        • La Meulière de la Marne
        • Contatto:
        • Investigatore principale:
          • Sylvie DELALANDE, DR
      • Nantes, Francia, 44100
        • Reclutamento
        • Résidence La Chézalière
        • Contatto:
        • Investigatore principale:
          • Marie-Anne MAITRE, DR
      • Nantes, Francia, 44200
        • Reclutamento
        • Parc de Diane
        • Contatto:
        • Investigatore principale:
          • Christian BLONZ, DR
      • Pacé, Francia, 35740
        • Reclutamento
        • Résidence Les Nymphéas
        • Contatto:
        • Investigatore principale:
          • Nolwenn DELARUE, DR
      • Pessac, Francia, 33600
        • Reclutamento
        • Villa Bourgailh
        • Contatto:
        • Investigatore principale:
          • Béatrice FONTAINE MARTINEZ, DR
      • Saint-Rogatien, Francia, 17220
        • Non ancora reclutamento
        • Villa Amélie
        • Contatto:
        • Investigatore principale:
          • Marion CHARENTON, DR
      • Salon-de-Provence, Francia, 13300
        • Non ancora reclutamento
        • Résidence Verte Prairie
        • Contatto:
        • Investigatore principale:
          • Sylvie DE BESOMBES, DR
      • Vannes, Francia, 56000
        • Non ancora reclutamento
        • Villa Tohannic
        • Contatto:
        • Investigatore principale:
          • Sophie DREVILLON, DR
      • Villenave-d'Ornon, Francia, 33140
        • Non ancora reclutamento
        • Les Jardins de Leysotte
        • Contatto:
        • Investigatore principale:
          • Isabelle MARCET, DR

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Exclusion Criteria:

  • 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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Altro: 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.
Sperimentale: 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).
Dispositivo: 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.
Altri nomi:
  • Music Care
  • Receptive Music Intervention
  • Digital Music Therapy
Sperimentale: 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).
Dispositivo: 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.
Altri nomi:
  • Music Care
  • Receptive Music Intervention
  • Digital Music Therapy

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Daily Degree of Hygiene Care Acceptance or Refusal as Assessed by a 4-Level Ordinal Scale Over 4 Weeks
Lasso di tempo: 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
Daily from Day 1 to Day 28 (Weeks 1-4)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Daily Duration of Hygiene Care Session Over 4 Weeks (Minutes)
Lasso di tempo: Daily from Day 1 to Day 28 (Weeks 1-4)
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.
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
Lasso di tempo: Baseline (Day 0) and 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.
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
Lasso di tempo: Baseline (Day 0) and 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.
Baseline (Day 0) and Week 8
Change from Baseline in Monthly Psychotropic Medication Use at Week 4
Lasso di tempo: 4 weeks prior to Baseline (Day 0) and Weeks 1-4 (J0 to S4)
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.
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
Lasso di tempo: Weeks 5-8 (S4 to S8)
Monthly psychotropic medication consumption (benzodiazepines, antidepressants, neuroleptics, hypnotics) from resident's medical records, assessed for the period S4 to S8. Evaluates sustained reduction in pharmacological BPSD management after the intervention period.
Weeks 5-8 (S4 to S8)
Change from Baseline in Caregiver Professional Burnout as Assessed by the Maslach Burnout Inventory (MBI) at Week 4
Lasso di tempo: Baseline (Day 0) and Week 4
The MBI is a 22-item self-report scale, completed anonymously by caregivers. Items rated 0 (never) to 6 (every day). Three subscales: (1) Emotional Exhaustion (9 items): range 0-54; higher = greater burnout; cut-offs: <17 low, 18-29 moderate, ≥30 high; (2) Depersonalization (5 items): range 0-30; higher = greater burnout; cut-offs: <5 low, 6-11 moderate, ≥12 high; (3) Personal Accomplishment (8 items): range 0-48; higher = LESS burnout; cut-offs: ≥40 low, 34-39 moderate, ≤33 high.
Baseline (Day 0) and Week 4
Change from Baseline in Caregiver Professional Burnout as Assessed by the Maslach Burnout Inventory (MBI) at Week 8
Lasso di tempo: Baseline (Day 0) and Week 8
Same MBI instrument as Outcome 7. Week 8 assessment evaluates whether any improvement in caregiver burnout is sustained after the 4-week intervention period. MBI subscale ranges and directions: Emotional Exhaustion 0-54 (higher = worse), Depersonalization 0-30 (higher = worse), Personal Accomplishment 0-48 (higher = better).
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
Lasso di tempo: Week 4
Two measures of protocolization compliance: (1) Number of caregivers (soignants) in the unit who performed MUSIC CARE© sessions during Weeks 1-4; (2) Total number of MUSIC CARE© sessions completed in the unit during Weeks 1-4. Higher rates indicate greater uptake and adoption of the protocolized intervention at the team level.
Week 4
Rate of MUSIC CARE© Protocolization as Measured by Number of Caregivers Using the Intervention and Number of Sessions Completed at Week 8
Lasso di tempo: Week 8
Same measures as Outcome 9, assessed at Week 8 (4 weeks after the end of the formal protocolized intervention period). Evaluates whether protocolized music use has been maintained spontaneously in the 4 weeks following the formal study period.
Week 8

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

LNA SANTE

Investigatori

  • Investigatore principale: Nolwenn DELARUE, DR, Les Nymphéas - LNA Santé

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

30 ottobre 2025

Completamento primario (Stimato)

30 giugno 2027

Completamento dello studio (Stimato)

30 giugno 2027

Date di iscrizione allo studio

Primo inviato

23 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

23 luglio 2026

Primo Inserito (Effettivo)

28 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

28 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

23 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2024-A00522-45

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

Individual participant data (IPD) sharing has not yet been determined. This is a pilot multicenter study (n=60 residents). Data are processed under French GDPR reference methodology MR-001. Caregiver data are fully anonymized. Results will be reported in an internal LNA Santé report and may be submitted for publication in a specialty medical journal. A decision on IPD sharing will be made prior to study completion.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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