Actively Recruiting

Age: 0 - 18Years
All Genders
NCT07414251

Evaluation of Preoperative Preparation in Children Undergoing Cardiac Surgery or Catheterization

Led by Charite University, Berlin, Germany · Updated on 2026-02-17

200

Participants Needed

1

Research Sites

74 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Children undergoing cardiac surgery or cardiac catheterization often experience significant stress and anxiety during the preoperative period. A prospective, observational assessment of the preoperative/ preinterventional phase in 100 children undergoing cardiac surgery or cardiac catheterization at the Deutsches Herzzentrum der Charité demonstrated a considerable proportion of pediatric patients present with clinically relevant levels of anxiety before these procedures. Several aspects of the preoperative workflow were identified as potentially modifiable to improve the preparation of children and their families. Based on these findings, changes in clinical practice were implemented. These measures aim to create a more supportive environment for children undergoing cardiac interventions or surgery. The investigators now aim to re-evaluate the current preoperative preparation process for children undergoing cardiac surgery or cardiac catheterization at the Deutsches Herzzentrum der Charité and to assess its impact on preoperative stress and anxiety levels. Another 100 children will be enrolled for this follow-up assessment (100 children assessed at baseline in 2025, 100 children to be assessed in 2026, starting end of January 2026). Anxiety and stress and other patient reported outcome and experience measures as well as procedural and clinical data are assessed using validated questionnaires and CRFs prior to the procedure. The perspectives of parents or legal guardians and members of the clinical care team will also be considered to provide a comprehensive view of the preoperative experience.

CONDITIONS

Official Title

Evaluation of Preoperative Preparation in Children Undergoing Cardiac Surgery or Catheterization

Who Can Participate

Age: 0 - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children undergoing cardiac surgery or cardiac catheterization
Not Eligible

You will not qualify if you...

  • Children who are already intubated, tracheotomized, or sedated
  • Families unable to understand the study or complete questionnaires due to language barriers without interpreter access
  • Emergency interventions
  • Death of the child

AI-Screening

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Trial Site Locations

Total: 1 location

1

DHZC, Charité Universtiätsmedizin Berlin

Berlin, State of Berlin, Germany, 10553

Actively Recruiting

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Research Team

M

Maren Kleine-Brueggeney, Prof. Dr.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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