An observational study in Congenital Heart Disease in Children, sponsored by Charite University, Berlin, Germany. Recruiting at 1 site in Germany. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by Charite University, Berlin, Germany · Observational
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's planned enrollment of 200 is above the median of 150 across 606 observational studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children undergoing cardiac surgery or cardiac catheterization.
Exclusion Criteria:
100 children assessed in 2025
100 children to be assessed in 2026
Parental Separation Anxiety Scale
PSAS; Preoperative anxiety level; scale from 1 (not anxious) to 4 (crying, fighting) plus necessity to administer propofol for separation
Time frame: At handover from ward to anaesthesia-/ cathlab-team
University of Michigan Sedation Score
UMSS, 5 point score from awake (0) to unarousable (4)
Time frame: At handover from ward to anaesthesia-/ cathlab-team
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
Time frame: at handover from ward to anaesthesia or cathlab-team
Faces scale
Faces scale (pictures of different faces) for children to express how they feel
Time frame: At handover from ward to anaesthesia-/ cathlab-team
VAS anxiety scale
Visual analog scale for children to assess how anxious they feel (0-10), higher scores represent more anxiety
Time frame: At handover of child from ward to anaesthesia-/ cathlab team
heart rate
heart rate
Time frame: At handover from ward to anaesthesia-/ cathlab team
Patient and parent reported outcome and experience measure
experience on the ward
Time frame: Between admission to the ward and handover to anaesthesia/ cathlab-team
Assessment of preoperative phase and anxiety/ wellbeing of the child by clinicians
Assessment by the team of the ward and the anaesthesia-/ cathlab-team
Time frame: From admission to the ward until sedation/ anaesthesia
Follow up
Assessment of the preoperative/ preinterventional phase by the child and/ or caregiver via telephone interview 2 weeks after surgery/ cathlab procedure
Time frame: 2 weeks after surgery / cathlab procedure
Plan to share: Undecided
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Charite University, Berlin, Germany