[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628034":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":37,"responsibleParty":52,"collaborators":25,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":25,"enrollmentInfo":64,"targetDuration":25,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":82,"whyStopped":25,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"CHU de Reims","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard care","ACTIVE_COMPARATOR","Participants receive standard critical care. Patient stimulation is performed according to usual practice by the healthcare team (e.g., during routine morning nursing care). Relatives are welcomed according to standard visiting policies; no structured family-delivered neurosensory stimulation protocol is implemented.",[13],"Behavioral: Standardized family-delivered neurosensory stimulation protocol",{"label":15,"type":16,"description":17,"interventionNames":18},"Family-delivered neurosensory stimulation","EXPERIMENTAL","Relatives deliver a standardized neurosensory (multisensory) stimulation protocol to the brain-injured patient during the early awakening phase after sedation cessation, under supervision of the healthcare team. The intervention includes an interview to identify reference relative(s) and patient habits, structured training on stimulation of the five senses, and traceability of stimulation activities performed at each visit.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Standardized family-delivered neurosensory stimulation protocol","A structured multisensory stimulation program delivered by trained relatives (reference family member\\[s\\]) during visits, targeting sight, hearing, touch, smell and (when appropriate) taste. Components: (1) baseline interview to tailor stimulation to patient preferences\u002Fhabits; (2) training in standardized techniques and safety guidance; (3) supervised implementation with staff support; (4) documentation\u002Ftraceability of each session.",[15,9],null,[27,33],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Sylvain BRICHET","CONTACT","03 10 73 69 97","0033","sbrichet@chu-reims.fr",{"name":34,"role":29,"phone":35,"phoneExt":31,"email":36},"Emmanuelle RACLOT","03 26 78 90 59","eraclot@chu-reims.fr",[38],{"facility":39,"status":25,"city":40,"state":25,"zip":25,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Marie MULLER","Reims","France","FR",{"type":44,"coordinates":45},"Point",[46,47],4.02853,49.26526,{"lat":47,"lon":46},[50,51],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},{"name":34,"role":29,"phone":35,"phoneExt":31,"email":36},{"type":53,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100628034","sensory-stimulation-program-delivered-by-family-members-of-brain-injured-patients-in-critical-care-effect-on-relatives-post-traumatic-stress-100628034",false,"NCT07456384","Sensory Stimulation Program Delivered by Family Members of Brain-injured Patients in Critical Care: Effect on Relatives' Post-traumatic Stress","Evaluation of the Impact of a Standardized Neurosensory Stimulation Protocol Delivered by Relatives of Brain-injured Patients Hospitalized in Critical Care on Post-traumatic Stress in Those Relatives","StimulSensRea","inclusion criteria :\n\n* Age ≥ 18 years\n* Relative (family member or close person) of an eligible brain-injured patient hospitalized in critical care\n* Able and willing to provide informed consent to participate.\n* Available to attend at least three visits during the patient's critical care hospitalization.\n* French-speaking (sufficient proficiency to understand study information and complete questionnaires).\n\nexclusion criteria :\n\n* Non-French-speaking or insufficient French proficiency to complete study procedures\u002Fquestionnaires.\n* Insufficient understanding\u002Fcomprehension of the study procedures, as assessed during the initial interview after explanations by the study nurse.","ALL","18 Years",{"count":65,"type":66},200,"ESTIMATED","INTERVENTIONAL",[69],"NA","Severe traumatic brain injuries are common and can lead to major long-term disability. Patients with severe brain injury often require admission to critical care. For relatives, this period is highly distressing: during and after an ICU stay, family members frequently experience anxiety, depression, and post-traumatic stress symptoms.\n\nIn recent years, family involvement in critical care has been associated with better communication with the healthcare team and fewer psychological difficulties among relatives. In parallel, findings from neuroscience suggest that early multisensory stimulation (engaging the five senses) may help support brain recovery by promoting neuronal connections during the awakening phase.\n\nThis study evaluates whether a standardized neurosensory stimulation program, delivered by trained relatives of brain-injured patients hospitalized in critical care, can reduce post-traumatic stress symptoms in those relatives. We hypothesize that involving relatives in a structured, supervised multisensory stimulation protocol during the patient's awakening phase (before transfer to rehabilitation) will decrease relatives' post-traumatic stress symptoms at 3 months after critical care discharge (or after the patient's death). We also expect potential secondary benefits on patients' awakening and recovery trajectory.",[72,73],"Stress Disorder","Post-traumatic",[75,76,77,78,79,80,81],"craniocerebral trauma","stress disorders","post-traumatic","anxiety","critical care","sensory stimulation","caregivers","NOT_YET_RECRUITING","2026-03-04",{"date":85,"type":86},"2026-03-06","ACTUAL",{"date":88,"type":66},"2026-05",{"date":90,"type":66},"2029-05",{"name":5,"class":6},1]