[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649134":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":39,"centralContacts":44,"locations":50,"responsibleParty":233,"collaborators":38,"id":235,"slug":236,"hasResults":237,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":237,"sex":243,"minAge":244,"maxAge":38,"enrollmentInfo":245,"targetDuration":38,"studyType":248,"phases":249,"briefSummary":251,"conditions":252,"keywords":257,"overallStatus":53,"whyStopped":38,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":273},{"fullName":5,"class":6},"LNA SANTE","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Control: Standard Care (Current Practice)","ACTIVE_COMPARATOR","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.",[13],"Other: Standard Nursing Home Care",{"label":15,"type":16,"description":17,"interventionNames":18},"Interventional 1: MUSIC CARE© During Care (20 minutes\u002Fday)","EXPERIMENTAL","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\u002Fheadphones 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).",[19],"Device: Receptive music therapy",{"label":21,"type":16,"description":22,"interventionNames":23},"Interventional 2: MUSIC CARE© Before and During Care (40 minutes\u002Fday)","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).",[19],[25,34],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DEVICE","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\u002Fheadphones. Dosing: 20 min\u002Fday during care (Arm 2) or 20 min before + 20 min during care (Arm 3) for 4 weeks.",[15,21],[31,32,33],"Music Care","Receptive Music Intervention","Digital Music Therapy",{"type":6,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"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.",[9],null,[40],{"name":41,"affiliation":42,"role":43},"Nolwenn DELARUE, DR","Les Nymphéas - LNA Santé","PRINCIPAL_INVESTIGATOR",[45],{"name":46,"role":47,"phone":48,"phoneExt":38,"email":49},"Eva BRIAND","CONTACT","(0)240160161 ext +33","eva.briand@lna-sante.com",[51,70,85,101,116,131,143,157,173,188,203,218],{"facility":52,"status":53,"city":54,"state":38,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Les Jardins d'Henriville","RECRUITING","Amiens","80000","France","FR",{"type":59,"coordinates":60},"Point",[61,62],2.3,49.9,{"lat":62,"lon":61},[65,69],{"name":66,"role":47,"phone":67,"phoneExt":38,"email":68},"Claire MARTEIN, DR","(+33)3 60 24 88 00","medec.jardinshenriville@lna-sante.com",{"name":66,"role":43,"phone":38,"phoneExt":38,"email":38},{"facility":71,"status":53,"city":72,"state":38,"zip":73,"country":56,"countryCode":57,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Villa d'Épidaure Garches","Garches","92380",{"type":59,"coordinates":75},[76,77],2.18232,48.84226,{"lat":77,"lon":76},[80,84],{"name":81,"role":47,"phone":82,"phoneExt":38,"email":83},"Merryl ZERBIB, DR","(+33)1 47 01 30 60","merryl.zerbib@lna-sante.com",{"name":81,"role":43,"phone":38,"phoneExt":38,"email":38},{"facility":86,"status":87,"city":88,"state":38,"zip":89,"country":56,"countryCode":57,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Villa d'Épidaure La Celle St Cloud","NOT_YET_RECRUITING","La Celle-Saint-Cloud","78170",{"type":59,"coordinates":91},[92,93],2.14523,48.85029,{"lat":93,"lon":92},[96,100],{"name":97,"role":47,"phone":98,"phoneExt":38,"email":99},"Anne JURET, DR","(+33)1 30 78 44 00","ajuret.epidaure78@lna-sante.com",{"name":97,"role":43,"phone":38,"phoneExt":38,"email":38},{"facility":102,"status":87,"city":103,"state":38,"zip":104,"country":56,"countryCode":57,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"La Meulière de la Marne","La Ferté-sous-Jouarre","77260",{"type":59,"coordinates":106},[107,108],3.12724,48.9514,{"lat":108,"lon":107},[111,115],{"name":112,"role":47,"phone":113,"phoneExt":38,"email":114},"Sylvie DELALANDE, DR","(+33)1 78 71 12 12","sdelalande.meuliere@lna-sante.com",{"name":112,"role":43,"phone":38,"phoneExt":38,"email":38},{"facility":117,"status":53,"city":118,"state":38,"zip":119,"country":56,"countryCode":57,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Résidence La Chézalière","Nantes","44100",{"type":59,"coordinates":121},[122,123],-1.55336,47.21725,{"lat":123,"lon":122},[126,130],{"name":127,"role":47,"phone":128,"phoneExt":38,"email":129},"Marie-Anne MAITRE, DR","(+33)2 51 84 78 47","medec.chezaliere@lna-sante.com",{"name":127,"role":43,"phone":38,"phoneExt":38,"email":38},{"facility":132,"status":53,"city":118,"state":38,"zip":133,"country":56,"countryCode":57,"cosmosGeoPoint":134,"geoPoint":136,"contacts":137},"Parc de Diane","44200",{"type":59,"coordinates":135},[122,123],{"lat":123,"lon":122},[138,142],{"name":139,"role":47,"phone":140,"phoneExt":38,"email":141},"Christian BLONZ, DR","(+33)2 51 79 52 00","medec.diane@lna-sante.com",{"name":139,"role":43,"phone":38,"phoneExt":38,"email":38},{"facility":144,"status":53,"city":145,"state":38,"zip":146,"country":56,"countryCode":57,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"Résidence Les Nymphéas","Pacé","35740",{"type":59,"coordinates":148},[149,150],-1.77435,48.14854,{"lat":150,"lon":149},[153,156],{"name":41,"role":47,"phone":154,"phoneExt":38,"email":155},"(+33)2 99 29 63 63","medec.nympheas@lna-sante.com",{"name":41,"role":43,"phone":38,"phoneExt":38,"email":38},{"facility":158,"status":53,"city":159,"state":38,"zip":160,"country":56,"countryCode":57,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"Villa Bourgailh","Pessac","33600",{"type":59,"coordinates":162},[163,164],-0.6324,44.80565,{"lat":164,"lon":163},[167,171],{"name":168,"role":47,"phone":169,"phoneExt":38,"email":170},"Béatrice FONTAINE-MARTINEZ, DR","(+33)5 57 01 94 00","medec.villabourgailh@lna-sante.com",{"name":172,"role":43,"phone":38,"phoneExt":38,"email":38},"Béatrice FONTAINE MARTINEZ, DR",{"facility":174,"status":87,"city":175,"state":38,"zip":176,"country":56,"countryCode":57,"cosmosGeoPoint":177,"geoPoint":181,"contacts":182},"Villa Amélie","Saint-Rogatien","17220",{"type":59,"coordinates":178},[179,180],-1.07092,46.15061,{"lat":180,"lon":179},[183,187],{"name":184,"role":47,"phone":185,"phoneExt":38,"email":186},"Marion CHARENTON, DR","(+33)5 17 83 40 40","medec1.amelie@lna-sante.com",{"name":184,"role":43,"phone":38,"phoneExt":38,"email":38},{"facility":189,"status":87,"city":190,"state":38,"zip":191,"country":56,"countryCode":57,"cosmosGeoPoint":192,"geoPoint":196,"contacts":197},"Résidence Verte Prairie","Salon-de-Provence","13300",{"type":59,"coordinates":193},[194,195],5.09478,43.64229,{"lat":195,"lon":194},[198,202],{"name":199,"role":47,"phone":200,"phoneExt":38,"email":201},"Sylvie DE BESOMBES, DR","(+33)4 90 56 38 00","sdebesombes.verteprairie@lna-sante.com",{"name":199,"role":43,"phone":38,"phoneExt":38,"email":38},{"facility":204,"status":87,"city":205,"state":38,"zip":206,"country":56,"countryCode":57,"cosmosGeoPoint":207,"geoPoint":211,"contacts":212},"Villa Tohannic","Vannes","56000",{"type":59,"coordinates":208},[209,210],-2.76205,47.65688,{"lat":210,"lon":209},[213,217],{"name":214,"role":47,"phone":215,"phoneExt":38,"email":216},"Sophie DREVILLON, DR","(+33)2 56 63 01 00","medec.villatohannic@lna-sante.com",{"name":214,"role":43,"phone":38,"phoneExt":38,"email":38},{"facility":219,"status":87,"city":220,"state":38,"zip":221,"country":56,"countryCode":57,"cosmosGeoPoint":222,"geoPoint":226,"contacts":227},"Les Jardins de Leysotte","Villenave-d'Ornon","33140",{"type":59,"coordinates":223},[224,225],-0.56707,44.77935,{"lat":225,"lon":224},[228,232],{"name":229,"role":47,"phone":230,"phoneExt":38,"email":231},"Isabelle MARCET, DR","(+33)5 64 12 08 00","medec.leysotte@lna-sante.com",{"name":229,"role":43,"phone":38,"phoneExt":38,"email":38},{"type":234,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","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":246,"type":247},60,"ESTIMATED","INTERVENTIONAL",[250],"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",[253,254,255,256],"Dementia","Cognitive Dysfunction","Psychomotor Agitation","Burnout, Professional",[253,258,259,32,260,261,262,263],"Music Therapy","Care Refusal","Non-Pharmacological Intervention","Behavioral and Psychological Symptoms of Dementia","Nursing Home","Professional Burnout","2026-07-23",{"date":266,"type":267},"2026-07-28","ACTUAL",{"date":269,"type":267},"2025-10-30",{"date":271,"type":247},"2027-06-30",{"name":5,"class":6},12]