Evaluation of Preoperative Preparation in Children Undergoing Cardiac Surgery or Catheterization
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Congenital Heart Disease in Children. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Preoperative Preparation for Pediatric Cardiac Surgery and Pediatric Cardiac Catheterization Procedures
Overview
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.
Primary outcome measures
- Parental Separation Anxiety Scale [Time frame: At handover from ward to anaesthesia-/ cathlab-team]
Secondary outcome measures (8)
- University of Michigan Sedation Score [Time frame: At handover from ward to anaesthesia-/ cathlab-team]
- Modified Yale Preoperative Anxiety Scale - Short Form [Time frame: at handover from ward to anaesthesia or cathlab-team]
- Faces scale [Time frame: At handover from ward to anaesthesia-/ cathlab-team]
- VAS anxiety scale [Time frame: At handover of child from ward to anaesthesia-/ cathlab team]
- heart rate [Time frame: At handover from ward to anaesthesia-/ cathlab team]
- Patient and parent reported outcome and experience measure [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 [Time frame: From admission to the ward until sedation/ anaesthesia]
- Follow up [Time frame: 2 weeks after surgery / cathlab procedure]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- DHZC, Charité Universtiätsmedizin Berlin — Berlin
Identifiers
NCT: NCT07414251 · EA2/209/24 · DRKS00035813