[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651370":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":30,"locations":37,"responsibleParty":56,"collaborators":18,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":18,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":40,"whyStopped":18,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Universidad Autonoma del Estado de Mexico","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","Therapeutic physical contact provided by their primary caregiver",[13],"Other: Standardized therapeutic physical contact",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Care Without Therapeutic Contact","NO_INTERVENTION","Standard intensive care unit care without the standardized therapeutic physical contact intervention provided by the primary caregiver.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Standardized therapeutic physical contact","During the pre-visit phase (30 minutes), caregivers will receive information about the study, patient's condition, infection control procedures, and training on the standardized contact protocol.\n\nDuring the visit phase (20 min), the caregiver will greet the patient in a customary manner (1 min); provide a gentle massage to the dorsal surface of the hand while discussing positive events of the day (6 min); gently touch the patient's forehead with the fingertips while recalling pleasant memories (3 min); gently massage the patient's cheek using the fingertips while providing encouraging and positive messages (3 minutes); massage the palm of the patient's hand using circular movements while discussing goals to be achieved after hospital discharge (4 min); and holding the patient's hand and expressing wishes for recovery and discharge (3 min).\n\nFollowing the visit, caregivers will be given the opportunity to share observations, comments, and feedback regarding the intervention experience.",[9],[25],"Physical contact",[27],{"name":28,"affiliation":5,"role":29},"Isabel Álvarez-Solorza, RN, PhD","PRINCIPAL_INVESTIGATOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Isabel Álvarez-Solorza, Dr.","CONTACT","+52 1 7222231161","8038","ialvarezs@uaemex.mx",[38],{"facility":39,"status":40,"city":41,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Investigación del Instituto Nacional de Enfermedades Respiratorias","RECRUITING","Mexico City","14080","Mexico","MX",{"type":46,"coordinates":47},"Point",[48,49],-99.12766,19.42847,{"lat":49,"lon":48},[52],{"name":53,"role":33,"phone":54,"phoneExt":18,"email":55},"Anely González-Colín, BSN","+52 1 5554871700","angonzalezc002@uaemex.mx",{"type":29,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Liliana Argueta-Figueroa","Professor-Researcher","100651370","physiological-changes-in-adult-intensive-care-patients-following-contact-with-their-primary-caregiver-100651370",false,"NCT07761364","Physiological Changes in Adult Intensive Care Patients Following Contact With Their Primary Caregiver","Physiological Changes in Adult Intensive Care Patients Upon Contact With Their Primary Caregiver (CARE-ICU): A Randomized Clinical Trial","CARE-ICU","Inclusion Criteria\n\nPatient Criteria:\n\n* Adults aged 18 years or older.\n* Admission to the intensive care unit (ICU) for 24 to 48 hours.\n* Richmond Agitation-Sedation Scale (RASS) score between -3 and -1 or between 0 and +3.\n* Glasgow Coma Scale score greater than 13.\n\nPrimary Caregiver Criteria:\n\n* Identified as the patient's primary caregiver.\n* Willing and able to participate in the study.\n* Provides written informed consent prior to study participation.\n\nExclusion Criteria\n\nPatient Criteria:\n\n* Diagnosis of a neurological disorder (e.g., cerebrovascular disease or stroke).\n* Multiple organ dysfunction syndrome (MODS).\n* Unstable or difficult-to-control cardiac arrhythmias.\n* Fever (body temperature ≥ 37.5°C) at the time of assessment.\n* Hypertension (blood pressure ≥ 130\u002F80 mmHg) at the time of assessment.\n\nPrimary Caregiver Criteria:\n\n\\- Unable to be present to perform the intervention according to the study protocol.","ALL","18 Years","59 Years",{"count":71,"type":72},80,"ESTIMATED","INTERVENTIONAL",[75],"NA","Patients admitted to intensive care units are exposed to multiple environmental and clinical factors that may affect their physiological responses. This randomized controlled trial aims to evaluate the effect of physical contact with the primary caregiver on physiological parameters in adult patients hospitalized in an intensive care unit.",[78,79],"Critical Illness","Critically Ill Patients",[81,78,79,82,83,84,85,86,87,88,89,90,91,92,93,94],"Intensive Care Unit","Primary Caregiver","Family Caregive","Therapeutic Touch","Physical Contact","Human Touch","Physiological Parameters","Physiological Response","Heart Rate","Blood Pressure","Respiratory Rate","Oxygen Saturation","Critical Care Nursing","Patient-Centered Care","2026-08-10",{"date":97,"type":98},"2026-08-12","ACTUAL",{"date":100,"type":98},"2026-08-01",{"date":102,"type":72},"2026-08-31",{"name":5,"class":6},1]