Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2026-01-04 @ 3:43 AM
Study NCT ID:
NCT02490995
Status:
COMPLETED
Last Update Posted:
2019-11-21
First Post:
2015-07-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inform and Reduce Pre-surgical Anxiety of the Child and His Parents: Interest of an Explanatory Movie.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009040', 'term': 'Motion Pictures'}], 'ancestors': [{'id': 'D001296', 'term': 'Audiovisual Aids'}, {'id': 'D018961', 'term': 'Educational Technology'}, {'id': 'D013672', 'term': 'Technology'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-19', 'studyFirstSubmitDate': '2015-07-02', 'studyFirstSubmitQcDate': '2015-07-06', 'lastUpdatePostDateStruct': {'date': '2019-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Yale Preoperative Anxiety Scale (m-YPAS)', 'timeFrame': 'the 1 surgery day at the time of the separation parents-children', 'description': 'Pre-surgical anxiety score of the children when separate from his parents, measured with the Yale Preoperative Anxiety Scale (m-YPAS)'}], 'secondaryOutcomes': [{'measure': 'Induction Compliance Checklist (ICC)', 'timeFrame': 'intraoperative', 'description': 'Score of "compliance" in the anesthetic induction measured by the ICC scale (hetero-assessment)'}, {'measure': 'The agitation in recovery room', 'timeFrame': 'First 15 minutes of the arrival in recovery room', 'description': 'The agitation in recovery room measured by the scale of agitation in the awakening of a pediatric anesthesia (EPAD) (hetero-assessment)'}, {'measure': 'psychometric validation of the SAS (self anxiety scale)', 'timeFrame': 'up to postoperative day 30', 'description': 'validation of the self report anxiety scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['children'], 'conditions': ['Anxiety Linked to the Surgery and / or Anesthesia']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to measure the interest of a movie explaining the path of the children in surgery, in order to reduce the anxiety of the children and his parents.\n\nThis study is interventional, method randomized, controled, open-label, comparing two parallel arms: anesthesist explanations versus anesthesist explanations + a movie explanation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient who need a surgery\n* Patient that general condition fit with American Society of Anesthesiologists (ASA) I to III classification.\n* Old patient under age 12\n* Patient whose parents agreed to participate\n\nExclusion Criteria:\n\n* Patient with psychomotor limitations\n* Patient that had already been hospitalised for a surgery'}, 'identificationModule': {'nctId': 'NCT02490995', 'briefTitle': 'Inform and Reduce Pre-surgical Anxiety of the Child and His Parents: Interest of an Explanatory Movie.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Inform and Reduce Pre-surgical Anxiety of the Child and His Parents: Interest of an Explanatory Movie About the Pathway of the Child in Pediatric Surgery.', 'orgStudyIdInfo': {'id': '9392'}, 'secondaryIdInfos': [{'id': '2014-A00416-41', 'type': 'REGISTRY', 'domain': 'ID RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Group A', 'description': 'Information given by the anaesthetist during the consultation'}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Movie + Information given by the anaesthetist during the consultation', 'interventionNames': ['Other: Movie']}], 'interventions': [{'name': 'Movie', 'type': 'OTHER', 'description': 'Besides the anesthesist explanations the children will have a movie explanation.', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Montpellier university hospital', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Sophie SB Bringuier, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montpellier University Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': '12 months after the main publication', 'ipdSharing': 'YES', 'description': 'De-identified data used in the published manuscript will be shared in accordance with the applicable informed consent under which the data was collected\n\nSupporting Information:\n\nTime Frame:\n\n12 months after the main publication\n\nAccess Criteria:\n\nData are provided to qualified investigators free of charge. Required documents to request data include a summary of the research plan, request form, and IRB review. Dataset will be shared after careful examination by the study board of investigators.\n\nIdentified data used in the published manuscript will be shared in accordance with the applicable informed consent under which the data was collected\n\nSupporting Information:', 'accessCriteria': 'Data are provided to qualified investigators free of charge. Required documents to request data include a summary of the research plan, request form, and IRB review. Dataset will be shared after careful examination by the study board of investigators.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}