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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Noninvasive Ventilation; Intensive Care (ICU); Ventilator Associated Events; Asynchrony, Patient-Ventilator
• Intervention / Treatment: Other: SYNC-NIV

• Study Type: Interventional
• Enrollment (Estimated): 92
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SYNC-NIV; 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.	Other: SYNC-NIV; 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.
No Intervention: Control Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, the day after SYNC-NIV program completion, and 1 week after program completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, the day after SYNC-NIV program completion, and 1 week after program completion
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.	Baseline, the day after SYNC-NIV program completion, and 1 week after program completion
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.	Baseline, the day after SYNC-NIV program completion, and 1 week after program completion

Collaborators and Investigators

• Sponsor: Shahid Beheshti University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): December 19, 2025
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): January 10, 2026

Study Registration Dates

• First Submitted: December 5, 2025
• First Submitted That Met QC Criteria: December 5, 2025
• First Posted (Estimated): December 18, 2025

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Randomized Clinical Trial; Non-Invasive Ventilation; Intensive Care Unit (ICU); Patient Comfort; Anxiety and Depression; Patient-Ventilator Synchrony
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Patient-Ventilator Asynchrony; Anxiety Disorders; Depression
• Other Study ID Numbers: IR.SBMU.RETECH.REC.1404.593

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No