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Can calmer prep cut Kids' heart surgery anxiety?

NCT ID NCT07414251

Knowledge-focused Sponsor: Charite University, Berlin, Germany 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at how changes in preoperative care affect anxiety in 100 children with congenital heart disease who need surgery or catheterization. Researchers will measure stress levels using questionnaires and scales, and also get feedback from parents and care teams. The goal is to find ways to make the experience less scary for children and their families.

What this could mean

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

What this could lead to
If successful, this could lead to better ways to prepare children for heart procedures, reducing their fear and stress.
What could go wrong
This is an observational study, not a treatment trial. It will measure anxiety but won't test a new drug or therapy. Results may not apply to other hospitals.

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.

Participants

About 200 people

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

Started

Jan 2025

Expected to finish

Jun 2026

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.

Who is studied

Children undergoing cardiac surgery or cardiac catheterization.

Ages

Up to 18 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 children undergoing cardiac surgery or cardiac catheterization. Exclusion Criteria: * Children who are already intubated or tracheotomized and sedated. * Children and families who, due to insufficient language skills and lack of interpreters, cannot be informed about the study and cannot consent, and/or cannot complete the questionnaires. * Emergency interventions. * Death of the child.

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Conditions

The condition(s) this trial relates to.

anxiety disorder congenital heart disease

As listed by the trial registrant

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

Congenital heart disease in children

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

  • DHZC, Charité Universtiätsmedizin Berlin

    RECRUITING

    Berlin, State of Berlin, 10553, Germany

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