Structured Receptive Music to Help with Care During Bathing for People with Dementia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized study tests whether a protocolized receptive music intervention (MUSIC CARE©) used during daily hygiene tasks can lower care refusal in older adults with dementia living in nursing homes. Participants are residents who show resistance to care and meet specific cognitive criteria, and their caregivers are involved in care delivery. The trial compares standard nursing home care with a 20-minute music session during care, and a 40-minute session that includes music before and during care, to see which approach best reduces distress and resistance. Outcomes focus on care refusals during bathing and hygiene, with secondary observations on behavioral symptoms. The study addresses non-pharmacological management of behavioral and psychological symptoms of dementia in a real-world nursing home setting.

Why it matters

Who can join: the full rules

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

Where it's running

• Les Jardins d'Henriville
  Amiens, France Recruiting
• Villa d'Épidaure Garches
  Garches, France Recruiting
• Résidence La Chézalière
  Nantes, France Recruiting
• Parc de Diane
  Nantes, France Recruiting
• Résidence Les Nymphéas
  Pacé, France Recruiting
• Villa Bourgailh
  Pessac, France Recruiting

Study contacts

• Principal investigator: Nolwenn DELARUE, DR — Les Nymphéas - LNA Santé
• Study coordinator: Eva BRIAND
• Email: eva.briand@lna-sante.com
• Phone: (0)240160161 ext +33

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.