Ignite Creation Date:
2025-12-24 @ 7:08 PM
Ignite Modification Date:
2025-12-29 @ 12:49 AM
Study NCT ID:
NCT00535457
Status:
WITHDRAWN
Last Update Posted:
2012-06-08
First Post:
2007-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Pre-operative Magic Tricks Performance on Pre-operative Anxiety in Children
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'lastUpdateSubmitDate': '2012-06-07', 'studyFirstSubmitDate': '2007-09-23', 'studyFirstSubmitQcDate': '2007-09-25', 'lastUpdatePostDateStruct': {'date': '2012-06-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'anxiety scores', 'timeFrame': 'Technical problems with video-taping of the patients still avoid us from recruiting patients. Therefore, the time frame of the study is still unclear tome.'}, {'measure': 'postoperative maladaptive behavior rate'}], 'secondaryOutcomes': [{'measure': 'preoperative anxiety scores and rate of postoperative maladaptive behavior'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['anxiety', 'maladaptive behavior', 'anesthesia', 'Anxiety before anesthesia and maladaptive behavior after anesthesia.'], 'conditions': ['Anxiety']}, 'descriptionModule': {'briefSummary': 'It is not uncommon for children to undergo surgery. Surgery is a threatening event that is composed of various stress-provoking stimuli. Pre-operative anxiety is a common emotional response among operated children and their parents. In the current study we are going to examine if tricks done by the anesthesiologist before anesthetic induction are equally as effective as oral midazolam premedication in the reduction of pre-operative anxiety in children before and after surgery. A successful anxiety reduction may be advantageous over pharmacological premedication by cost reduction, a possibly shorter post anesthesia care stay and by reducing postoperative maladaptive behavior rate.\n\nStudy hypothesis: 1. similar anxiety scores will be observed in children that will watch their anesthesiologist performing tricks and in those who will receive oral midazolam premedication but no tricks.\n\n2\\. Similar rates of postoperative maladaptive behavior will be found in children that that will see tricks and in those that will receive midazolam premedication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 3-12 years\n* minor surgeries / diagnostic procedures such as endoscopy, biopsy\n\nExclusion Criteria:\n\n* children that do not speak Hebrew\n* American Society of Anesthesiologists (ASA) status above II\n* a need for regional anesthesia only\n* a need for an intravenous (IV) cannulation at the induction room or operating room before the induction of anesthesia.'}, 'identificationModule': {'nctId': 'NCT00535457', 'briefTitle': 'The Effects of Pre-operative Magic Tricks Performance on Pre-operative Anxiety in Children', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'The Effects of Pre-operative Magic Tricks Performance on Pre-operative Anxiety in Children', 'orgStudyIdInfo': {'id': 'SHEBA-07-4786-ZS-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Children will watch tricks ("magic") before anesthesia induction', 'interventionNames': ['Other: Preoperative Magic Tricks']}], 'interventions': [{'name': 'Preoperative Magic Tricks', 'type': 'OTHER', 'description': 'Watching "magic"; Study patients will watch the anesthesiologist performing tricks ("magic") before anesthesia induction.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52621', 'city': 'Tel Litwinsky', 'country': 'Israel', 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}], 'overallOfficials': [{'name': "Ze'ev Shenkman, MD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheba Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': "Ze'ev Shenkman, MD", 'oldOrganization': 'Sheba Medical Center, Department of Anesthesia C'}}}}