[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649592":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":31,"responsibleParty":50,"collaborators":26,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":26,"enrollmentInfo":64,"targetDuration":26,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":75,"overallStatus":34,"whyStopped":26,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Giresun University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Structured Education Group","EXPERIMENTAL","Participants in this group will receive a structured face-to-face educational program developed by the researchers before the patient undergoes tracheostomy. The education will include information about the purpose of tracheostomy, the procedure, post-tracheostomy care, communication with the patient, potential problems, and the role of family members in the care process.",[13],"Behavioral: Structured Education Program",{"label":15,"type":16,"description":17,"interventionNames":18},"Routine Information Group","ACTIVE_COMPARATOR","Participants in this group will receive routine verbal information provided by healthcare professionals as part of the standard clinical practices of the intensive care unit. The structured educational program developed by the researchers will not be provided to this group.",[19],"Other: Routine Information",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Structured Education Program","The structured education will be delivered face-to-face to the family member before the patient undergoes tracheostomy. The program will cover the purpose and necessity of tracheostomy, the procedure, changes that may occur after tracheostomy, communication methods, basic care principles, potential complications, and the involvement of family members in the care process. Participants' questions will be addressed during the educational session.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Routine Information","Participants will receive routine verbal information provided by healthcare professionals according to the standard clinical practice of the intensive care unit. No structured educational program will be provided.",[15],[32],{"facility":33,"status":34,"city":35,"state":35,"zip":36,"country":37,"countryCode":26,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Giresun Training and Research Hospital","RECRUITING","Giresun","28200","Turkey (Türkiye)",{"type":39,"coordinates":40},"Point",[41,42],38.38741,40.91698,{"lat":42,"lon":41},[45],{"name":46,"role":47,"phone":48,"phoneExt":26,"email":49},"ALKAY KARA, PhD","CONTACT","+90 539 441 64 97","alkay@outlook.com.tr",{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Alkay Kara","Assistant Professor, PhD","100649592","effect-of-structured-education-for-family-members-of-intensive-care-patients-undergoing-tracheostomy-100649592",false,"NCT07737353","Effect of Structured Education for Family Members of Intensive Care Patients Undergoing Tracheostomy","The Effect of Structured Education Provided to Family Members of Patients Undergoing Tracheostomy in the Intensive Care Unit on Anxiety, Psychological Well-Being, and Satisfaction With Care: A Randomized Controlled Trial","TRACH-FAMILY","Inclusion Criteria:\n\n* Family member or primary caregiver of a patient scheduled to undergo tracheostomy in one of the participating intensive care units.\n* Aged 18 years or older.\n* Able to read, understand, and communicate in Turkish.\n* Willing to participate in the study.\n* Provides written informed consent.\n* Actively involved in the patient's care and treatment process.\n\nExclusion Criteria:\n\n* Diagnosed with a severe psychiatric disorder.\n* Severe hearing, visual, or cognitive impairment that prevents completion of the study questionnaires.\n* Communication problems that prevent participation in the data collection process.\n* Declines to participate in the study.","ALL","18 Years",{"count":65,"type":66},84,"ESTIMATED","INTERVENTIONAL",[69],"NA","Family members of patients undergoing tracheostomy in the intensive care unit frequently experience anxiety, uncertainty, and concerns regarding the patient's care. This randomized controlled trial aims to evaluate the effect of structured education provided to family members of patients undergoing tracheostomy in the intensive care unit on state anxiety, psychological well-being, and satisfaction with care. Participants will be randomly assigned to either the intervention or control group. The intervention group will receive structured education before tracheostomy, whereas the control group will receive routine information. Outcomes will be assessed before tracheostomy, on the first day after tracheostomy, and one week after the procedure.",[72,73,74],"Tracheostomy","Critical Illness","Intensive Care",[76,77,78,72,79,80,81,82,83],"Structured Education","Family Members","Intensive Care Unit","Anxiety","Psychological Well-Being","Satisfaction With Care","Family-Centered Care","Randomized Controlled Trial","2026-07-27",{"date":86,"type":87},"2026-07-30","ACTUAL",{"date":89,"type":87},"2026-05-18",{"date":91,"type":66},"2027-05-18",{"name":5,"class":6},1]