Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT01622218
Status:
COMPLETED
Last Update Posted:
2020-11-12
First Post:
2012-05-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of Medical Clowning on Pain and Stress Level in Pediatric Patients Undergoing Hernia Repair Surgery LAUGH Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006554', 'term': 'Hernia, Umbilical'}, {'id': 'D006552', 'term': 'Hernia, Inguinal'}], 'ancestors': [{'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006555', 'term': 'Hernia, Ventral'}, {'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-09', 'studyFirstSubmitDate': '2012-05-30', 'studyFirstSubmitQcDate': '2012-06-14', 'lastUpdatePostDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Children: WBS (Wong Baker Faces Pain Rating Scale)', 'timeFrame': '24 hours', 'description': 'measure at 4 time points (repeated measures) - at admission, discharge, 12 and 24 hours.'}], 'secondaryOutcomes': [{'measure': 'Use of analgesics', 'timeFrame': 'During the 24 hours following the surgery', 'description': 'Total dose of analgesics over 24 periods per kg.'}, {'measure': 'Cytokines levels', 'timeFrame': 'End of precedure, before waking up', 'description': 'Cytokined levels at the end of the surgery (end of precedure, before waking up)(IL-1b, IL-2,IL-6, IL-8, IL-10,TNF-α and VEGF)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Medical clown'], 'conditions': ['Umbilical Hernia', 'Inguinal Hernia']}, 'descriptionModule': {'briefSummary': 'The purpose of our study to quantitatively examine the stress levels prior to surgery and the use of analgesics post surgery in both children and their parents following a preoperative intervention with a medical clown compared to children that were not exposed to this intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ages 4-10 years old\n* undergoing elective umbilical or inguinal hernia repair surgery\n* ASA Physical Status = 1\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01622218', 'briefTitle': 'The Impact of Medical Clowning on Pain and Stress Level in Pediatric Patients Undergoing Hernia Repair Surgery LAUGH Study.', 'organization': {'class': 'OTHER', 'fullName': 'Soroka University Medical Center'}, 'officialTitle': 'The Impact of Medical Clowning on Pain and Stress Level in Pediatric Patients Undergoing Hernia Repair Surgery LAUGH Study', 'orgStudyIdInfo': {'id': 'sor007112clit'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Medical Clown', 'description': "Presence of clowns on child's postoperative pain levels, anxiety levels of the child and the accompanying parent and the effect of the intervention on the total consumption of analgesics and on the post- surgery inflammatory markers.", 'interventionNames': ['Behavioral: Medical Clown']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': "Assessment of child's postoperative pain levels, anxiety levels of the child and the accompanying parent and the effect on the total consumption of analgesics and on the post- surgery inflammatory markers."}], 'interventions': [{'name': 'Medical Clown', 'type': 'BEHAVIORAL', 'description': "Presence of clowns on child's postoperative pain levels, anxiety levels of the child and the accompanying parent and the effect of the intervention on the total consumption of analgesics and on the post- surgery inflammatory markers", 'armGroupLabels': ['Medical Clown']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84101', 'city': 'Beersheba', 'country': 'Israel', 'facility': 'Soroka University Medical Center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'city': 'Beersheba', 'country': 'Israel', 'facility': 'Assuta Medical Center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soroka University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Nitza Heiman Newman, MD', 'investigatorAffiliation': 'Soroka University Medical Center'}}}}