Ignite Creation Date:
2025-12-24 @ 6:30 PM
Ignite Modification Date:
2026-01-01 @ 8:32 PM
Study NCT ID:
NCT04608968
Status:
RECRUITING
Last Update Posted:
2024-11-27
First Post:
2020-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pediatric Perioperative Satisfaction Questionnaire
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010549', 'term': 'Personal Satisfaction'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-25', 'studyFirstSubmitDate': '2020-09-24', 'studyFirstSubmitQcDate': '2020-10-24', 'lastUpdatePostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Children satisfaction after surgery', 'timeFrame': 'at discharge of hospital ( from the day of surgery up 14 days)', 'description': 'to develop a questionnaire (score 0 to 100) to assess the satisfaction of children after surgery (from the day of surgery to 2 weeks)'}], 'secondaryOutcomes': [{'measure': 'postoperative pain intensity', 'timeFrame': 'at discharge of hospital ( from the day of surgery up 14 days)', 'description': 'to assess the level of children postoperative pain intensity (from the day of surgery to 2 weeks). Pain was assessed using the Face Pain Scale revised tool (0-10).'}, {'measure': 'perioperative anxiety level', 'timeFrame': 'at discharge of hospital ( from the day of surgery up 14 days)', 'description': 'to assess perioperative anxiety level using the Visual Analog Scale (0-10) of children after surgery (from the day of surgery to 2 weeks)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Validity', 'Questionnaire', 'Children', 'health quality of life', 'Self report'], 'conditions': ['Perioperative', 'Children', 'Satisfaction']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to develop and validate a self-report questionnaire to evalutate the satisfaction of the children after surgery.', 'detailedDescription': 'Step 1 : development of the questiontionnaire Face to face interview to report the satisfaction of the children after surgery and to identify recurrent themes to generate questions.\n\nStep 2 : validation of the questionnaire Evaluation of the psychometric validity of the final questionnaire'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '7 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'children 7 years and older after surgery', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* children 7 years and older\n* elective surgery\n* general anesthesia\n* abiliy to understand and read questions\n\nExclusion criteria:\n\n* emergency\n* cognitive trouble\n* intellectual disability'}, 'identificationModule': {'nctId': 'NCT04608968', 'briefTitle': 'Pediatric Perioperative Satisfaction Questionnaire', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Development and Validation of a Perioperative Satisfaction Questionnaire in Children Population', 'orgStudyIdInfo': {'id': 'RECHMPL20_0346'}}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'state': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sophie BRINGUIER', 'role': 'CONTACT', 'email': 'fs-bringuierbranchereau@chu-montpellier.fr', 'phone': '+33 4 67 33 86 61'}], 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Karine, NOUETTE', 'role': 'CONTACT', 'email': 'karine.nouette-gaulain@u-bordeaux.fr'}], 'facility': 'UH Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Grenoble', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Noël EVAIN, MD', 'role': 'CONTACT', 'email': 'jnevain@chu-grenoble.fr'}], 'facility': 'UH Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Nîmes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe CUVILLON', 'role': 'CONTACT', 'email': 'philippe.cuvillon@chu-nimes.fr'}], 'facility': 'UH Nîmes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'city': 'Reims', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Daphné MICHELET, MD', 'role': 'CONTACT', 'email': 'dmichelet@chu-reims.fr'}], 'facility': 'UH Reims', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Delphine KERN, MD', 'role': 'CONTACT', 'email': 'kern.d@chu-toulouse.fr'}], 'facility': 'UH Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'sophie Bringuier', 'role': 'CONTACT', 'email': 's-bringuierbranchereau@chu-montpellier.fr', 'phone': '04 67 33 86 61', 'phoneExt': '33'}], 'overallOfficials': [{'name': 'Christophe DADURE, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}