[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"psychomotor-agitation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:psychomotor-agitation":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,52],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100649134","protocolized-receptive-music-intervention-to-reduce-care-refusal-in-nursing-home-residents-with-major-neurocognitive-disorders-100649134",false,"NCT07730957","Protocolized Receptive Music Intervention to Reduce Care Refusal in Nursing Home Residents With Major Neurocognitive Disorders","Impact of Protocolizing Receptive Music Intervention on Care Refusal During Hygiene Care in Nursing Home Residents With Major Neurocognitive Disorders","OPPOZIC'","RESIDENT ELIGIBILITY\n\nInclusion Criteria:\n\n* Living in a LNA Santé EHPAD (nursing home) as a permanent resident for at least 3 months\n* 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)\n* Showing care refusal behavior, defined as an Agitation\u002FAggression item score on the NPI-ES scale (frequency × severity) greater than or equal to 4 at the time of inclusion\n* Resident and\u002For their legal representative or trusted person has given written consent to participate\n* Affiliated to a French social security scheme\n\nExclusion Criteria:\n\n* Uncompensated hearing loss with sensory isolation (unable to benefit from music therapy)\n* Documented end-of-life status in the medical record\n\nCAREGIVER ELIGIBILITY\n\nInclusion Criteria (Caregivers):\n\n* Adult (18 years of age or older)\n* Working in the care unit of an enrolled resident and performing hygiene\u002Fnursing care (bathing)\n* Able to read and write French\n* Affiliated to a French social security scheme\n* Has given written consent to participate\n\nExclusion Criteria (Caregivers):\n\n* Employment contract shorter than the resident's 3-month study follow-up period (i.e., unable to complete all 3 caregiver assessments)\n* Unable to provide informed consent to participate\n* Under legal protection as defined by Article 1121-8 of the French Public Health Code (under legal guardianship or deprived of liberty)\n* Not affiliated to a French social security scheme","ALL","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"NA","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).\n\nWhat 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.\n\nThe main questions this study aims to answer are:\n\n* Can a structured, daily music program reduce care refusal during bathing and hygiene care compared to current practice?\n* 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)?\n* Does the music program also reduce distressing behavioral symptoms in residents?\n* Does it reduce the need for sedative or psychiatric medications?\n* Does it reduce professional burnout in caregivers who perform hygiene care?\n\nResearchers will compare three groups:\n\n* Group 1 (Control): Current practice - care staff may use MUSIC CARE© at their own discretion, as they already do\n* Group 2 (Music During Care): Structured use of MUSIC CARE© for 20 minutes during every hygiene care session, daily for 4 weeks\n* 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\n\nNursing homes (not individual residents) are randomly assigned to a group.\n\nResidents and their caregivers will:\n\n* Have their level of care refusal recorded daily for 4 weeks\n* Have neuropsychiatric symptoms and medication use assessed at the start, Week 4, and Week 8\n* Caregivers will also complete a confidential and anonymous professional burnout questionnaire at 3 time points",[27,28,29,30],"Dementia","Cognitive Dysfunction","Psychomotor Agitation","Burnout, Professional",[27,32,33,34,35,36,37,38],"Music Therapy","Care Refusal","Receptive Music Intervention","Non-Pharmacological Intervention","Behavioral and Psychological Symptoms of Dementia","Nursing Home","Professional Burnout","RECRUITING","2026-07-23",{"date":42,"type":43},"2026-07-28","ACTUAL",{"date":45,"type":43},"2025-10-30",{"date":47,"type":21},"2027-06-30",{"name":49,"class":50},"LNA SANTE","OTHER",12,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100558818","clinical-trial-of-peer-support-in-the-ed-pcori-100558818","NCT06556069","Clinical Trial of Peer Support in the ED (PCORI)","Peer Support Enhanced Behavioral Crisis Response Teams in the Emergency Department","Inclusion Criteria:\n\n* 18 years of age or older\n* English-speaking\n* Arrives to one of the Yale-New Haven Health emergency departments (Yale-New Haven \\[York Street \\& St. Raphael's\\], Greenwich, Bridgeport, Lawrence \\& Memorial, and Westerly campuses)\n* Presents with a behavioral-related chief complaint (inclusive of neurocognitive, substance use\u002Fintoxication, mental health and other behavioral related presentations) as well as additional individuals at risk of developing agitation defined via a score of \\>2 on the Brøset Violence Checklist\n\nExclusion Criteria:\n\n* Pregnant women, minors (\\\u003C18 years old), prisoners, and institutionalized individuals",true,{"count":61,"type":21},57870,[24],"The purpose of this study is to conduct a clinical trial that tests the acceptability, fidelity, and feasibility of a peer support modified intervention for agitation management within the emergency department.",[29,65],"Behavioral Disorder",[67,68],"Agitation","Peer Support","NOT_YET_RECRUITING","2026-05-15",{"date":72,"type":43},"2026-05-18",{"date":74,"type":21},"2026-07-01",{"date":76,"type":21},"2029-05-01",{"name":78,"class":50},"Yale University",1]