DHZC, Charité Universtiätsmedizin Berlin
Berlin, State of Berlin, 10553, Germany
Location status: Recruiting
NCT Number: NCT07414251
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.
Interested in participating?
Request InfoUp to 18 year
All sexes
Observational
Berlin, State of Berlin, 10553, Germany
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: At handover from ward to anaesthesia-/ cathlab-team
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
UMSS, 5 point score from awake (0) to unarousable (4)
Time frame: at handover from ward to anaesthesia or cathlab-team
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-/ cathlab-team
Faces scale (pictures of different faces) for children to express how they feel
Time frame: At handover of child from ward to anaesthesia-/ cathlab team
Visual analog scale for children to assess how anxious they feel (0-10), higher scores represent more anxiety
Time frame: At handover from ward to anaesthesia-/ cathlab team
heart rate
Time frame: Between admission to the ward and handover to anaesthesia/ cathlab-team
experience on the ward
Time frame: From admission to the ward until sedation/ anaesthesia
Assessment by the team of the ward and the anaesthesia-/ cathlab-team
Time frame: 2 weeks after surgery / cathlab procedure
Assessment of the preoperative/ preinterventional phase by the child and/ or caregiver via telephone interview 2 weeks after surgery/ cathlab procedure
Contact information is provided by the study sponsor or research team.
Charite University, Berlin, Germany
Other
Evaluation of the Preoperative Preparation for Pediatric Cardiac Surgery and Pediatric Cardiac Catheterization Procedures
Acronym: GETREADY
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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