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A short lesson before a tracheostomy may calm families' fears

NCT ID NCT07737353

Symptom relief Sponsor: Giresun University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This trial tests whether a structured education session for family members of ICU patients about to receive a tracheostomy can lower their anxiety, boost their psychological well-being, and increase their satisfaction with care. Half of the participants get the structured program before the procedure; the other half receive only routine information. Researchers measure anxiety, well-being, and satisfaction before the tracheostomy, one day after, and one week later.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A structured education program delivered face-to-face before tracheostomy, covering the procedure, communication, care, and complications.
What this could lead to
If effective, this program could become a standard way to support families, reducing their anxiety and improving their satisfaction with ICU care.
What could go wrong
This is a single-center trial with 84 participants, so results may not apply to all settings. The benefit over routine information may be small.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 84 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

anxiety disorder Critical Illness Psychological Well-Being

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Critical illness Intensive care Tracheostomy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Giresun Training and Research Hospital

    RECRUITING

    Giresun, Giresun, 28200, Turkey (Türkiye)

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