NCT07414251 Evaluation of Preoperative Preparation in Children Undergoing Cardiac Surgery or Catheterization
| NCT ID | NCT07414251 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Charite University, Berlin, Germany |
| Condition | Congenital Heart Disease in Children |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-01-09 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2025-01-09 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07414251 clinical trial?
This trial is open to participants of all sexes, up to 18 Years, studying Congenital Heart Disease in Children. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07414251 currently recruiting?
Yes, NCT07414251 is actively recruiting participants. Contact the research team at maren.kleine-brueggeney@dhzc-charite.de for enrollment information.
Where is the NCT07414251 trial being conducted?
This trial is being conducted at Berlin, Germany.
Who is sponsoring the NCT07414251 clinical trial?
NCT07414251 is sponsored by Charite University, Berlin, Germany. The trial plans to enroll 200 participants.