Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2026-03-18 @ 3:07 AM
Study NCT ID:
NCT02675504
Status:
COMPLETED
Last Update Posted:
2019-01-11
First Post:
2016-02-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of a Scale of Self-assessment of Fear Faces in Children 4 to 12 Years
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 544}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-10', 'studyFirstSubmitDate': '2016-02-03', 'studyFirstSubmitQcDate': '2016-02-03', 'lastUpdatePostDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of children who validate the 6 faces expressing fear.', 'timeFrame': '5 minutes', 'description': 'Percentage of children who validate the 6 faces expressing fear. The test will be validated if we get a result at least 60%.'}], 'secondaryOutcomes': [{'measure': 'Percentage of children who properly fit the faces expressing fear in ascending and descending order.', 'timeFrame': '5 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['scary scale'], 'conditions': ['Fear']}, 'referencesModule': {'references': [{'pmid': '35300885', 'type': 'DERIVED', 'citation': 'Thurillet S, Bahans C, Wood C, Bougnard S, Labrunie A, Messager V, Toniolo J, Beloni P, Fourcade L. Psychometric properties of a self-assessment fear scale in children aged 4 to 12 years. Scary Scale. J Pediatr Nurs. 2022 Jul-Aug;65:108-115. doi: 10.1016/j.pedn.2022.02.020. Epub 2022 Mar 14.'}]}, 'descriptionModule': {'briefSummary': 'Since the 2000s, the experiences of children and especially their fear during a consultation, a treatment or examination is food for thought in our establishment. There is no tool validated self-assessment of fear to 6 faces. It therefore appeared necessary to us to create this tool. The scale self-assessment of the fear that we have developed consists of six faces representing a gradual level of fear: the child can easily describe their level of fear, which allows for appropriate care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '4 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participating in the study of children aged 4 to 12 years. In this study, participation of school children and hospitalized children', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 4 to 12 years.\n* Enrolled in one of the participating institutions in the study (steps 1-5) or consultant pediatric emergencies at the Children of Limoges (step 6).\n* Authorization of at least one person having parental authority for the child to participate in the study.\n* Children affiliates or benefiting from a social security\n\nExclusion Criteria:\n\n* Children with psychomotor disorders that prevent the use of the scale studied and understanding instructions.\n* Children in vital emergency'}, 'identificationModule': {'nctId': 'NCT02675504', 'acronym': 'TROUILLOMETRE', 'briefTitle': 'Validation of a Scale of Self-assessment of Fear Faces in Children 4 to 12 Years', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Limoges'}, 'officialTitle': 'Validation of a Scale of Self-assessment of Fear Faces in Children 4 to 12 Years: Scary Scale', 'orgStudyIdInfo': {'id': 'I14006'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Placing a scale self-assessment of fear', 'type': 'OTHER', 'description': 'Children spend a self-assessment scale of fear'}]}, 'contactsLocationsModule': {'locations': [{'zip': '87 042', 'city': 'Limoges', 'country': 'France', 'facility': 'Limoges hospital', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Limoges', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}