Actively Recruiting
Evaluation of the Preoperative Preparation for Pediatric Cardiac Surgery and Pediatric Cardiac Catheterization Procedures
Led by Charite University, Berlin, Germany · Updated on 2026-02-17
200
Participants Needed
1
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Children undergoing cardiac surgery or cardiac catheterization often face significant stress and anxiety before their procedures. Researchers observed that many pediatric patients show clinically relevant anxiety levels during the preoperative phase. Based on initial findings, clinical practices were adjusted to better support children and their families during this time. This study aims to reassess the updated preoperative preparation process and its impact on reducing stress and anxiety in children undergoing these cardiac interventions. The study will enroll 100 children in 2025 and another 100 in 2026 to evaluate the current preoperative process. Data will be collected before the cardiac surgery or catheterization procedure using validated questionnaires and clinical report forms (CRFs). The assessments will include patient- and parent-reported outcomes, as well as perspectives from clinical care teams to provide a comprehensive understanding of the preoperative experience. Participants will be evaluated using multiple anxiety and stress measurement tools, such as the Parental Separation Anxiety Scale, University of Michigan Sedation Score, Modified Yale Preoperative Anxiety Scale, and others at the handover from the ward to anesthesia or catheterization team. Heart rate and wellbeing assessments will also be recorded from admission until sedation or anesthesia. Follow-up evaluations will occur two weeks after the procedure to monitor outcomes and experiences.
CONDITIONS
Brief Title
Evaluation of Preoperative Preparation in Children Undergoing Cardiac Surgery or Catheterization
Who Can Participate
Eligibility Criteria
You may qualify if you...
- All children undergoing cardiac surgery or cardiac catheterization.
You will not qualify if you...
- 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.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From admission to the ward until sedation or anesthesia
Participants undergo preoperative assessments to evaluate anxiety and wellbeing before cardiac surgery or catheterization.
1 visit (in-person)
Duration - 2 weeks after surgery or catheterization procedure
Participants and parents are followed up to assess outcomes and experiences after the cardiac procedure.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
DHZC, Charité Universtiätsmedizin Berlin
Berlin, State of Berlin, Germany, 10553
Actively Recruiting
Research Team
M
Maren Kleine-Brueggeney, Prof. Dr.
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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