Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 12:44 AM
Study NCT ID:
NCT00609960
Status:
COMPLETED
Last Update Posted:
2008-02-07
First Post:
2008-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clowns as Treatment for Preoperative Anxiety in Children: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-02-06', 'studyFirstSubmitDate': '2008-01-24', 'studyFirstSubmitQcDate': '2008-02-06', 'lastUpdatePostDateStruct': {'date': '2008-02-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'anxiety level', 'timeFrame': 'waiting area and enterance to OR -1 hour'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['children anesthesia anxiety clowns'], 'conditions': ['Pre Operative Anxiety']}, 'descriptionModule': {'briefSummary': 'This study wants to test the hypothesis that trained clowns can reduce anxiety in children undergoing general anesthesia. We will compare the effect of the clowns to the commonly used anti-anxiety medication we commonly use', 'detailedDescription': "The perioperative environment, often anxiety-provoking for adults, may be quite frightening for children. The detrimental effects of preoperative anxiety are not confined to the preoperative period. Anxiety during induction of anesthesia is correlated with increased distress early in the postoperative period, (Holms Knud, Kain) and maladaptive behavior will follow for the first 2 weeks following surgery in up to 54% of children.\n\nMany preoperative systems allow parental, pharmacologic, and anticipatory interventions to facilitate a relaxed perioperative environment for children. Unfortunately, scheduling conflicts, side effects, and limited resources conspire to limit their usefulness. For example, only 10% of respondents in a recent survey used parental presence during induction of anesthesia (PPIA) for a majority of their patients. This may be due to the belief by some that parental anxiety may in fact increase children's anxiety. (Bevans) According to the same survey, only 50% of children undergoing surgery receive sedating premedication. (Kain). Distraction techniques, such as the use of toys or video games, may also decrease perioperative anxiety, however their effectiveness during induction of anesthesia is not well characterized. The efficacy of toys and video games is somewhat dependent upon the child reaching certain developmental milestones. Anesthesiologists continue to search for an easy and comprehensive method for anxiety reduction in the pediatric surgical population. We propose that specially trained professional clowns may allay preoperative anxiety and result in a smooth anesthetic induction."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ASA I and II\n* Children aged 2-8 years\n\nExclusion Criteria:\n\n* Previous surgery\n* ASA \\> II\n* Parents' refusal"}, 'identificationModule': {'nctId': 'NCT00609960', 'briefTitle': 'Clowns as Treatment for Preoperative Anxiety in Children: A Randomized Controlled Trial', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Clowns as Treatment for Preoperative Anxietyin Children- a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SHEBA-05-3739-IK-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '1', 'description': 'no medication or clowns present during the preopertaive phase'}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'midazolam a anxiolytic drug was given in the preoperative phase', 'interventionNames': ['Drug: midazolam']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'clowns where present during the preoperative phase', 'interventionNames': ['Behavioral: clowns present']}], 'interventions': [{'name': 'clowns present', 'type': 'BEHAVIORAL', 'description': 'clowns present during the proccess of induction of anesthesia', 'armGroupLabels': ['3']}, {'name': 'midazolam', 'type': 'DRUG', 'description': 'midazolam', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52621', 'city': 'Tel Litwinsky', 'state': 'Ramat Gan', 'country': 'Israel', 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}], 'overallOfficials': [{'name': 'Ilan Keidan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheba Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Ilan Keidan MD, Director pediatric anesthesia', 'oldOrganization': 'Sheba Medical Center'}}}}