Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Structured education for families of patients with tracheostomy in the ICU

Official title: The Effect of Structured Education Provided to Family Members of Patients Undergoing Tracheostomy in the Intensive Care Unit on Anxiety, Psychological Well-Being, and Satisfaction With Care: A Randomized Controlled Trial

Run by Giresun University · NCT07737353 · Data updated 2026-11-12

This trial tests whether giving a structured education session to family members of ICU patients with tracheostomies can reduce their state anxiety and improve well-being and satisfaction with care.

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Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment84 (estimated)
SponsorGiresun University
Academic / other
Locations1 site (Giresun, Giresun)
StatusRecruiting
StartedMay 18, 2026
Main results expectedMay 18, 2027
Study endsMay 18, 2027
Registry record updatedJuly 30, 2026
Trial IDNCT07737353 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Family members or primary caregivers of a patient scheduled for tracheostomy in the ICU, aged 18 or older, literate in Turkish, and willing to participate.

Probably not a fit

Family members who do not experience anxiety or who cannot benefit from the education approach may not see a benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, parallel-group study conducted in an ICU setting to see if a structured face-to-face education program for family members of patients undergoing tracheostomy improves their state anxiety, psychological well-being, and satisfaction with care compared with routine information. Participants are randomized 1:1 to receive either the structured education before the procedure or standard information. Outcomes are measured at baseline (before tracheostomy), the first day after tracheostomy, and one week after the procedure. The study is being conducted at Giresun Training and Research Hospital and aims to enroll 84 family members.

Why it matters

Potential benefit: If effective, structured education could reduce family anxiety and improve satisfaction with care during a patient’s tracheostomy in the ICU.

How similar studies have gone: Prior studies in ICU settings suggest education for families can impact anxiety and satisfaction, but this specific structured program for tracheostomy care is novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Giresun Training and Research Hospital
    Giresun, Giresun, Turkey (Türkiye)
    Recruiting

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.