NCT07414251

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Congenital Heart Disease in Children

Timeline

• Start date: 2025-01-09
• Primary completion: 2026-06-01
• Completion: 2026-06-15
• First posted: 2026-02-17
• Last updated: 2026-02-17

Locations

1 site across 1 country: Germany