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| ID | Type | Description | Link |
|---|---|---|---|
| DRKS00035813 | Registry Identifier | German Clinical Trials Register (DRKS) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baseline | 100 children assessed in 2025 | ||
| Follow up | 100 children to be assessed in 2026 |
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| Measure | Description | Time Frame |
|---|---|---|
| Parental Separation Anxiety Scale | PSAS; Preoperative anxiety level; scale from 1 (not anxious) to 4 (crying, fighting) plus necessity to administer propofol for separation | At handover from ward to anaesthesia-/ cathlab-team |
| Measure | Description | Time Frame |
|---|---|---|
| University of Michigan Sedation Score | UMSS, 5 point score from awake (0) to unarousable (4) | At handover from ward to anaesthesia-/ cathlab-team |
| Modified Yale Preoperative Anxiety Scale - Short Form |
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Inclusion Criteria:
Exclusion Criteria:
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Children undergoing cardiac surgery or cardiac catheterization.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maren Kleine-Brueggeney, Prof. Dr. | Contact | +493045932618 | maren.kleine-brueggeney@dhzc-charite.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DHZC, Charité Universtiätsmedizin Berlin | Recruiting | Berlin | State of Berlin | 10553 | Germany |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
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mYPAS-SF; Score across 4 categories, 100 is maximum, 22.9 is minimum, higher scores represent worse measures
| at handover from ward to anaesthesia or cathlab-team |
| Faces scale | Faces scale (pictures of different faces) for children to express how they feel | At handover from ward to anaesthesia-/ cathlab-team |
| VAS anxiety scale | Visual analog scale for children to assess how anxious they feel (0-10), higher scores represent more anxiety | At handover of child from ward to anaesthesia-/ cathlab team |
| heart rate | heart rate | At handover from ward to anaesthesia-/ cathlab team |
| Patient and parent reported outcome and experience measure | experience on the ward | Between admission to the ward and handover to anaesthesia/ cathlab-team |
| Assessment of preoperative phase and anxiety/ wellbeing of the child by clinicians | Assessment by the team of the ward and the anaesthesia-/ cathlab-team | From admission to the ward until sedation/ anaesthesia |
| Follow up | Assessment of the preoperative/ preinterventional phase by the child and/ or caregiver via telephone interview 2 weeks after surgery/ cathlab procedure | 2 weeks after surgery / cathlab procedure |
| D000013 |
| Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |