About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
All children undergoing cardiac surgery or cardiac catheterization.
Disqualifiers
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.
Trial population
Children undergoing cardiac surgery or cardiac catheterization.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Parental Separation Anxiety Scale
PSAS; Preoperative anxiety level; scale from 1 (not anxious) to 4 (crying, fighting) plus necessity to administer propofol for separation
Secondary outcomes
University of Michigan Sedation Score
UMSS, 5 point score from awake (0) to unarousable (4)
Modified Yale Preoperative Anxiety Scale - Short Form
mYPAS-SF; Score across 4 categories, 100 is maximum, 22.9 is minimum, higher scores represent worse measures
Faces scale
Faces scale (pictures of different faces) for children to express how they feel
VAS anxiety scale
Visual analog scale for children to assess how anxious they feel (0-10), higher scores represent more anxiety
Sponsors and contacts
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