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.
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
Patients with Richmond Agitation-Sedation Scale (RASS) scores of +4 or -5
Patients with cognitive disorders
Patients with neurological disorders
Patients with anxiety disorders
Parallel
SYNC-NIV
Other interventionThe 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.
NIV Usage
Adherence data, including daily NIV usage, will be retrieved from the NIV machine. Adherence will be defined as more than 4 hours of nighttime use for more than 70% of days until study completion or a mean daily use of more than 5 hours.
Anxiety and Depression
Levels of anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS), a 14-item self-report instrument divided into two subscales: anxiety (HADS-A) and depression (HADS-D), each comprising seven items. Participants will rate each item on a 4-point scale (0-3), yielding subscale scores ranging from 0 to 21. Scores for both subscales will be interpreted as follows: 0-7 indicating no symptoms, 8-10 mild, 11-14 moderate, and 15-21 severe. The internal consistency of the anxiety subscale (HADS-A) and depression subscale (HADS-D) will have been demonstrated with Cronbach's alpha coefficients of 0.820 and 0.807, respectively. The Persian version of the HADS will have shown good reliability and validity in clinical populations. Montazeri et al. (2003) will have found it acceptable by 99% of patients, with Cronbach's alpha of 0.78 for anxiety and 0.86 for depression subscales.
Respiratory Symptoms, Sleep Quality, and NIV-Associated Adverse Events
Respiratory Symptoms, Sleep Quality, and NIV-Associated Adverse Events The S3-NIV Questionnaire will be a self-administered tool that includes 11 questions, all scored by patients on a 5-point Likert scale that ranges from 0 to 4 (0 = always true; 1 = mostly true; 2 = sometimes true; 3 = mostly untrue; 4 = completely untrue), based on their experiences over the previous four weeks. To calculate the overall score, the average of all completed items will be multiplied by 2.5. A score of zero will reflect the highest degree of disease impact, whereas a score of ten will reflect the lowest. Two subscale scores may also be derived: the "Respiratory Symptoms" sub score will be computed by averaging responses to items 1, 4, 5, 6, and 7 and multiplying by 2.5, while the "Sleep \& Side Effects" sub score will be based on the average of items 2, 3, 8, 9, 10, and 11, also multiplied by 2.5.
Comfort
To evaluate participants' comfort levels, the Visual Analog Scale (VAS) will be employed. The VAS will be a widely used, reliable, and sensitive instrument for assessing subjective experiences such as comfort (6). It typically will consist of a 10-centimeter horizontal line anchored by two extremes, for example, "no discomfort" on the left end (score 0) and "worst possible discomfort" on the right end (score 10). Participants will mark a point along the line that best represents their perceived level of comfort. The simplicity, sensitivity, and ease of administration of the VAS will make it a preferred tool in both clinical and research settings for quantifying subjective states.
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