Effect of Structured Education for Family Members of Intensive Care Patients Undergoing Tracheostomy (NCT07737353) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Structured Education for Family Members of Intensive Care Patients Undergoing Tracheostomy
Turkey (Türkiye)84 participantsStarted 2026-05-18
Plain-language summary
Family members of patients undergoing tracheostomy in the intensive care unit frequently experience anxiety, uncertainty, and concerns regarding the patient's care. This randomized controlled trial aims to evaluate the effect of structured education provided to family members of patients undergoing tracheostomy in the intensive care unit on state anxiety, psychological well-being, and satisfaction with care. Participants will be randomly assigned to either the intervention or control group. The intervention group will receive structured education before tracheostomy, whereas the control group will receive routine information. Outcomes will be assessed before tracheostomy, on the first day after tracheostomy, and one week after the procedure.
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:
* Family member or primary caregiver of a patient scheduled to undergo tracheostomy in one of the participating intensive care units.
* Aged 18 years or older.
* Able to read, understand, and communicate in Turkish.
* Willing to participate in the study.
* Provides written informed consent.
* Actively involved in the patient's care and treatment process.
Exclusion Criteria:
* Diagnosed with a severe psychiatric disorder.
* Severe hearing, visual, or cognitive impairment that prevents completion of the study questionnaires.
* Communication problems that prevent participation in the data collection process.
* Declines to participate in the study.
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
1
State-Trait Anxiety Inventory (STAI) Score
Timeframe: Baseline before tracheostomy, 1 day after tracheostomy, and 1 week after tracheostomy
2
Psychological Well-Being Scale Score
Timeframe: Baseline before tracheostomy, 1 day after tracheostomy, and 1 week after tracheostomy
3
Family Satisfaction in the Intensive Care Unit-24 (FS-ICU-24) Score
Timeframe: Baseline before tracheostomy, 1 day after tracheostomy, and 1 week after tracheostomy