RecruitingNCT07414251

Evaluation of Preoperative Preparation in Children Undergoing Cardiac Surgery or Catheterization

Evaluation of the Preoperative Preparation for Pediatric Cardiac Surgery and Pediatric Cardiac Catheterization Procedures


Sponsor

Charite University, Berlin, Germany

Enrollment

200 participants

Start Date

Jan 9, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Max Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates how children are prepared emotionally and psychologically before heart surgery or a heart catheterization procedure (a thin tube inserted into the heart to diagnose or treat conditions). The goal is to understand what preparation methods work best to reduce stress for children and their families. **You may be eligible if...** - Your child is scheduled for cardiac surgery or cardiac catheterization **You may NOT be eligible if...** - Your child is already on a breathing machine (intubated or tracheotomized) and sedated - Your family does not speak the local language and no interpreter is available Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

DHZC, Charité Universtiätsmedizin Berlin

Berlin, State of Berlin, Germany

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NCT07414251


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