[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615362":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":18,"locations":18,"responsibleParty":23,"collaborators":18,"id":27,"slug":28,"hasResults":29,"nctId":30,"briefTitle":31,"officialTitle":32,"acronym":18,"eligibilityCriteria":33,"healthyVolunteers":29,"sex":34,"minAge":35,"maxAge":18,"enrollmentInfo":36,"targetDuration":18,"studyType":39,"phases":40,"briefSummary":42,"conditions":43,"keywords":48,"overallStatus":55,"whyStopped":18,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":18},{"fullName":5,"class":6},"Shahid Beheshti University of Medical Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SYNC-NIV","EXPERIMENTAL","The intervention will consist of a structured two-session synchrony-optimized NIV education program designed to improve patient-ventilator interaction and reduce NIV-related complications. In the first 20-40-minute session, patients will be taught the ventilator's inspiratory and expiratory cycles and will practice synchronizing their breathing with the device through guided diaphragmatic exercises and real-time feedback until they demonstrate stable synchrony. The second 45-60-minute session, delivered 18-24 hours later, will provide supplementary training on proper mask selection and fixation, prevention of common NIV complications, leak reduction techniques, equipment maintenance, advanced breathing exercises, and basic ventilator monitoring and alarm management. An educational booklet summarizing all essential topics will be provided to support ongoing adherence and self-management.",[13],"Other: SYNC-NIV",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","NO_INTERVENTION","Standard care will include regular education on the ICU environment, basic intensive care processes, the use of monitoring devices, ICU rules, effective communication with critically ill patients, and basic principles of patient care.",null,[20],{"type":6,"name":9,"description":21,"armGroupLabels":22,"otherNames":18},"The intervention will include two educational sessions to improve patient-ventilator synchrony and NIV management. The first session will teach patients about the ventilator's breathing cycles and train them to coordinate their breathing using visual aids and hands-on practice with real-time feedback. Competency will be assessed by their ability to maintain synchrony with minimal mask leak. The second session, held 18-24 hours later, will cover mask fitting, prevention of common complications, leak reduction, equipment care, advanced breathing exercises, and basic ventilator alarm management. Communication and relaxation techniques will also be taught, and patients will receive a booklet summarizing the key information.",[9],{"type":24,"investigatorFullName":25,"investigatorTitle":26,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Sogand Sarmadi","Principal Investigator","100615362","synchrony-optimized-non-invasive-ventilation-education-program-and-icu-patients-100615362",false,"NCT07291622","Synchrony-Optimized Non-Invasive Ventilation Education Program and ICU Patients","Effect of a Synchrony-Optimized Non-Invasive Ventilation Education Program on Intensive Care Unit Patients' Outcomes: A Randomized Clinical Trial Protocol","Inclusion Criteria:\n\n* Adult patients over 18 years of age\n* Admitted to the ICU for at least 24 hours\n* Anticipated to be hospitalized for more than one week\n* Receiving NIV treatment for any underlying condition\n* Capable of learning\n* Proficient in the Persian language\n\nExclusion Criteria:\n\n* Patients with Richmond Agitation-Sedation Scale (RASS) scores of +4 or -5\n* Patients with cognitive disorders\n* Patients with neurological disorders\n* Patients with anxiety disorders\n* Patients whose condition deteriorates, making continued cooperation impossible\n* Patients unable to participate in educational sessions","ALL","18 Years",{"count":37,"type":38},92,"ESTIMATED","INTERVENTIONAL",[41],"NA","The aim of this clinical trial is to find out whether a synchrony-optimized education program for non-invasive ventilation (NIV) can help ICU patients use their ventilator more effectively and improve their comfort, symptoms, and psychological well-being.\n\nResearchers want to answer these main questions:\n\nCan a structured two-session NIV education program help patients use their ventilator more regularly and for longer periods?\n\nDoes this type of training reduce anxiety, depression, and respiratory symptoms?\n\nCan synchrony training improve patients' comfort and reduce NIV-related problems such as mask leaks or sleep disturbances?\n\nIs this program more effective than the routine ICU education normally provided?\n\nWhat Will Happen in the Study\n\nAdults (18+) who are receiving NIV in the ICU will participate in this study.\n\nParticipants will be randomly assigned to one of two groups:\n\nIntervention Group: Will receive the SYNC-NIV education program, consisting of:\n\nOne hands-on session (20-40 minutes) teaching patients how to synchronize their breathing with the ventilator\n\nOne supplementary session (45-60 minutes) covering mask management, preventing complications, reducing leaks, breathing exercises, equipment care, and alarm handling\n\nAn educational booklet for continued support\n\nControl Group: Will receive the standard ICU education normally provided about the ICU environment, general care, communication, and monitoring.\n\nAll participants will be evaluated at three times:\n\nbefore the intervention, the day after the program ends, and one week later.",[44,45,46,47],"Ventilator Associated Events","Asynchrony, Patient-Ventilator","Intensive Care (ICU)","Noninvasive Ventilation",[49,50,51,52,53,54],"Non-Invasive Ventilation","Patient-Ventilator Synchrony","Intensive Care Unit (ICU)","Anxiety and Depression","Randomized Clinical Trial","Patient Comfort","NOT_YET_RECRUITING","2025-12-17",{"date":58,"type":59},"2025-12-24","ACTUAL",{"date":61,"type":38},"2025-12-19",{"date":63,"type":38},"2026-01-10",{"name":5,"class":6}]