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Practice stoma bag before surgery? new study tests if it eases fear

NCT ID NCT06737887

Symptom relief Sponsor: Kocaeli 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether having patients practice with a stoma bag one day before surgery can lower their anxiety and help them adjust afterward. About 58 adults scheduled for stoma surgery will either get this simulation or standard care. Researchers will measure anxiety levels and how well patients adapt to the stoma after the operation.

What this could mean

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

Active substance
stoma simulation (a practice session with a stoma bag)
What this could lead to
If it works, this simple practice session could help patients feel less anxious and adjust better to life with a stoma after surgery.
What could go wrong
This is a small, early-stage trial with only 58 participants, so results may not apply to everyone. The simulation is a one-time practice, and its long-term benefits are uncertain.

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 58 people

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

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Jan 2028

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 to 65 years

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: * All patients who are planned for elective stoma surgery, * Are between the ages of 18-65, * Can speak Turkish, * Can read and write, * Are conscious, * Are willing to participate in the study will be included. Exclusion Criteria: * Patients with speech or hearing impairments, * Those who have had urostomy surgery, * Those who have a psychological diagnosis or are taking medication, * Those who need intensive care after surgery, * Those whose stoma was closed during the study, * Those who have complications in the peristomal area, * Patients who have had stoma surgery before will be excluded from the study.

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As listed by the trial registrant

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

Colostomy - stoma Ileostomy - stoma

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

  • Istanbul University Istanbul Medical Faculty Hospital

    RECRUITING

    Istanbul, Turkey (Türkiye)

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