Ignite Creation Date:
2025-12-24 @ 12:53 PM
Ignite Modification Date:
2026-01-06 @ 5:18 PM
Study NCT ID:
NCT00261261
Status:
COMPLETED
Last Update Posted:
2005-12-02
First Post:
2005-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Family-Centered Behavioral Preparation for Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-11', 'completionDateStruct': {'date': '2004-12'}, 'lastUpdateSubmitDate': '2005-11-30', 'studyFirstSubmitDate': '2005-11-30', 'studyFirstSubmitQcDate': '2005-11-30', 'lastUpdatePostDateStruct': {'date': '2005-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anxiety in children: modified Yale Preoperative anxiety scale'}, {'measure': 'Anxiety in parents: STAI'}], 'secondaryOutcomes': [{'measure': 'Emergence delirium'}, {'measure': 'Analgesic consumption'}, {'measure': 'Time to discharge from recovery room'}]}, 'conditionsModule': {'keywords': ['children', 'anxiety', 'behavioral preparation', 'family', 'surgery', 'parents'], 'conditions': ['Anxiety']}, 'descriptionModule': {'briefSummary': 'Children experience significant anxiety and distress during the preoperative period. Currently available interventions are ineffective and/or associated with significant disadvantages. These interventions exclusively target the child and do not attempt to reduce parental anxiety. Based on an integration of the literature in both the anesthesia and psychological milieus, we developed ADVANCE, a behaviorally oriented anxiety reduction program for children undergoing surgery that targets the family as a whole.', 'detailedDescription': 'Children and their parents (n=408) were randomly assigned to one of four groups: 1) Control: received standard of care, 2) PPIA: received standard parental presence during induction of anesthesia, 3) ADVANCE: received family-centered behavioral preparation, and 4) oral Midazolam. We assessed the effect of group assignment on anxiety levels and postoperative outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children 2-10 years old who were in good health (American Society of Anesthesiology physical status I-II) and who were undergoing general anesthesia and elective, outpatient surgery, and their parents.\n\nExclusion Criteria:\n\n* Children with a history of chronic illness, prematurity (fewer than 36 weeks gestation) or reported developmental delay'}, 'identificationModule': {'nctId': 'NCT00261261', 'briefTitle': 'Family-Centered Behavioral Preparation for Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Study of the ADVANCE Behavioral Preparation Program for Children and Their Parents', 'orgStudyIdInfo': {'id': 'ADVANCE'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ADVANCE', 'type': 'BEHAVIORAL'}, {'name': 'Midazolam', 'type': 'DRUG'}, {'name': 'Parental presence', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Zeev N Kain, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Research Resources (NCRR)', 'class': 'NIH'}]}}}