Not Yet RecruitingNot Applicable

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

92 participantsStarted 2025-12-19

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patients over 18 years of age * Admitted to the ICU for at least 24 hours * Anticipated to be hospitalized for more than one week * Receiving NIV treatment for any underlying condition * Capable of learning * Proficient in the Persian language Exclusion Criteria: * Patients with Richmond Agitation-Sedation Scale (RASS) scores of +4 or -5 * Patients with cognitive disorders * Patients with neurological disorders * Patients with anxiety disorders * Patients whose condition deteriorates, making continued cooperation impossible * Patients unable to participate in educational sessions

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

NIV Usage

Timeframe: Baseline, the day after SYNC-NIV program completion, and 1 week after program completion

Trial details

NCT IDNCT07291622

SponsorShahid Beheshti University of Medical Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-30

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