Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 2:37 PM
Study NCT ID:
NCT07414251
Status:
RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Preoperative Preparation in Children Undergoing Cardiac Surgery or Catheterization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-10', 'studyFirstSubmitDate': '2026-01-21', 'studyFirstSubmitQcDate': '2026-02-10', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Parental Separation Anxiety Scale', 'timeFrame': 'At handover from ward to anaesthesia-/ cathlab-team', 'description': 'PSAS; Preoperative anxiety level; scale from 1 (not anxious) to 4 (crying, fighting) plus necessity to administer propofol for separation'}], 'secondaryOutcomes': [{'measure': 'University of Michigan Sedation Score', 'timeFrame': 'At handover from ward to anaesthesia-/ cathlab-team', 'description': 'UMSS, 5 point score from awake (0) to unarousable (4)'}, {'measure': 'Modified Yale Preoperative Anxiety Scale - Short Form', 'timeFrame': 'at handover from ward to anaesthesia or cathlab-team', 'description': 'mYPAS-SF; Score across 4 categories, 100 is maximum, 22.9 is minimum, higher scores represent worse measures'}, {'measure': 'Faces scale', 'timeFrame': 'At handover from ward to anaesthesia-/ cathlab-team', 'description': 'Faces scale (pictures of different faces) for children to express how they feel'}, {'measure': 'VAS anxiety scale', 'timeFrame': 'At handover of child from ward to anaesthesia-/ cathlab team', 'description': 'Visual analog scale for children to assess how anxious they feel (0-10), higher scores represent more anxiety'}, {'measure': 'heart rate', 'timeFrame': 'At handover from ward to anaesthesia-/ cathlab team', 'description': 'heart rate'}, {'measure': 'Patient and parent reported outcome and experience measure', 'timeFrame': 'Between admission to the ward and handover to anaesthesia/ cathlab-team', 'description': 'experience on the ward'}, {'measure': 'Assessment of preoperative phase and anxiety/ wellbeing of the child by clinicians', 'timeFrame': 'From admission to the ward until sedation/ anaesthesia', 'description': 'Assessment by the team of the ward and the anaesthesia-/ cathlab-team'}, {'measure': 'Follow up', 'timeFrame': '2 weeks after surgery / cathlab procedure', 'description': 'Assessment of the preoperative/ preinterventional phase by the child and/ or caregiver via telephone interview 2 weeks after surgery/ cathlab procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anxiety', 'congenital heart disease', 'PROMS', 'PREMS'], 'conditions': ['Congenital Heart Disease in Children']}, 'descriptionModule': {'briefSummary': '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.\n\nBased 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children undergoing cardiac surgery or cardiac catheterization.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All children undergoing cardiac surgery or cardiac catheterization.\n\nExclusion Criteria:\n\n* Children who are already intubated or tracheotomized and sedated.\n* 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.\n* Emergency interventions.\n* Death of the child.'}, 'identificationModule': {'nctId': 'NCT07414251', 'acronym': 'GETREADY', 'briefTitle': 'Evaluation of Preoperative Preparation in Children Undergoing Cardiac Surgery or Catheterization', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Evaluation of the Preoperative Preparation for Pediatric Cardiac Surgery and Pediatric Cardiac Catheterization Procedures', 'orgStudyIdInfo': {'id': 'EA2/209/24'}, 'secondaryIdInfos': [{'id': 'DRKS00035813', 'type': 'REGISTRY', 'domain': 'German Clinical Trials Register (DRKS)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Baseline', 'description': '100 children assessed in 2025'}, {'label': 'Follow up', 'description': '100 children to be assessed in 2026'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10553', 'city': 'Berlin', 'state': 'State of Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'DHZC, Charité Universtiätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'centralContacts': [{'name': 'Maren Kleine-Brueggeney, Prof. Dr.', 'role': 'CONTACT', 'email': 'maren.kleine-brueggeney@dhzc-charite.de', 'phone': '+493045932618'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesiology', 'investigatorFullName': 'Prof. Dr. med. Maren Kleine-Brüggeney', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}