Synchrony-Optimized Non-Invasive Ventilation Education Program and ICU Patients

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. Researchers want to answer these main questions: Can a structured two-session NIV education program help patients use their ventilator more regularly and for longer periods? Does this type of training reduce anxiety, depression, and respiratory symptoms? Can synchrony training improve patients' comfort and reduce NIV-related problems such as mask leaks or sleep disturbances? Is this program more effective than the routine ICU education normally provided? What Will Happen in the Study Adults (18+) who are receiving NIV in the ICU will participate in this study. Participants will be randomly assigned to one of two groups: Intervention Group: Will receive the SYNC-NIV education program, consisting of: One hands-on session (20-40 minutes) teaching patients how to synchronize their breathing with the ventilator One supplementary session (45-60 minutes) covering mask management, preventing complications, reducing leaks, breathing exercises, equipment care, and alarm handling An educational booklet for continued support Control Group: Will receive the standard ICU education normally provided about the ICU environment, general care, communication, and monitoring. All participants will be evaluated at three times: before the intervention, the day after the program ends, and one week later.

NCT Number	NCT07291622
Lead Sponsor	Shahid Beheshti University of Medical Sciences
Conditions	Ventilator Associated Events, Asynchrony, Patient-Ventilator, Intensive Care (ICU), Noninvasive Ventilation
Enrollment	92 participants
Start Date	2025-12-19
Primary Completion	2025-12-30 (estimated)
Study Completion	2026-01-10 (estimated)
Updated on ClinicalTrials.gov	2025-12-24