Preoperative preparation for children undergoing heart surgery or catheter procedures
Evaluation of the Preoperative Preparation for Pediatric Cardiac Surgery and Pediatric Cardiac Catheterization Procedures
Charite University, Berlin, Germany · NCT07414251
See if recent changes to how children and families are prepared before cardiac surgery or catheterization at Charité reduce preoperative anxiety and improve patient-reported experiences.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany (other) |
| Locations | 1 site (Berlin, State of Berlin) |
| Trial ID | NCT07414251 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational re-evaluation of the preoperative and preinterventional process for children undergoing cardiac surgery or catheterization at the Deutsches Herzzentrum der Charité. Children and families will complete validated patient-reported outcome and experience measures (PROMs and PREMs) and standardized anxiety screenings before procedures, while staff workflow and preparatory steps are documented. The team implemented targeted practice changes after an initial assessment of 100 patients and will compare current patient-reported outcomes and process measures to those earlier findings. No experimental medical treatments are given; the focus is on measuring real-world effects of the updated preparation pathway on children and families.
Who should consider this trial
Good fit: Children scheduled for elective cardiac surgery or cardiac catheterization at the Deutsches Herzzentrum der Charité who are not intubated or sedated and whose families can provide consent and complete questionnaires are ideal candidates.
Not a fit: Children requiring emergency interventions, those already intubated or sedated, or families unable to participate because of language barriers are unlikely to benefit from this re-evaluation.
Why it matters
Potential benefit: If successful, these process changes could lower children’s preoperative anxiety and make the care experience easier and more supportive for families.
How similar studies have performed: A prior observational assessment at this center found clinically relevant preoperative anxiety in many patients, and similar pediatric preoperative preparation programs elsewhere have sometimes reduced anxiety and improved patient experience.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All children undergoing cardiac surgery or cardiac catheterization. Exclusion Criteria: * 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.
Where this trial is running
Berlin, State of Berlin
- DHZC, Charité Universtiätsmedizin Berlin — Berlin, State of Berlin, Germany (RECRUITING)
Study contacts
- Study coordinator: Maren Kleine-Brueggeney, Prof. Dr.
- Email: maren.kleine-brueggeney@dhzc-charite.de
- Phone: +493045932618
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Congenital Heart Disease in Children, anxiety, congenital heart disease, PROMS, PREMS