Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2025-12-28 @ 6:27 PM
Study NCT ID:
NCT07088692
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-28
First Post:
2025-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Observation and Risk Factor Analysis of the Incidence of Postoperative PTSD in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-05-21', 'size': 205959, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-07-20T11:50', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-05-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-20', 'studyFirstSubmitDate': '2025-07-20', 'studyFirstSubmitQcDate': '2025-07-20', 'lastUpdatePostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall incidence of PTSD at different time points', 'timeFrame': '6 months', 'description': 'Morbidity of enrolled children during follow-up assessed by CPSS questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PTSD', 'PMTS'], 'conditions': ['PTSD']}, 'descriptionModule': {'briefSummary': 'Preoperative anxiety, pain, and repeated exposure to general anesthesia may increase the risk of post-traumatic stress disorder (PTSD) in children. This study aims to establish a clinical database by collecting the incidence and risk factors of PTSD in children aged 6 to 12 undergoing elective surgery under general anesthesia, with a primary focus on evaluating the overall postoperative PTSD incidence, its incidence at different time points, and identifying potential risk factors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study will enroll children aged 6 to 12 years scheduled for elective surgery under general anesthesia. Exclusion criteria include: a history of psychiatric disorders or significant cognitive impairment, recent upper respiratory tract infection or severe pulmonary disease (within the past two weeks), undergoing emergency surgery or trauma-related surgery under general anesthesia, or preoperative chronic pain.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 6-12 years scheduled for elective surgery under general anesthesia.\n* Parent or legal guardian provides informed consent and agrees to complete a 1-year follow-up.\n\nExclusion Criteria:\n\n* History of psychiatric disorders (e.g., PTSD, anxiety disorders), substance abuse, long-term use of steroids or hormonal medications.\n* Significant cognitive impairment that hinders understanding of study procedures.\n* Emergency surgery or trauma-related procedures requiring urgent general anesthesia.\n* Recent (within two weeks) upper respiratory tract infection or severe pulmonary disease.'}, 'identificationModule': {'nctId': 'NCT07088692', 'briefTitle': 'Clinical Observation and Risk Factor Analysis of the Incidence of Postoperative PTSD in Children', 'organization': {'class': 'OTHER', 'fullName': 'The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College'}, 'officialTitle': 'Clinical Observation and Risk Factor Analysis of the Incidence of Postoperative PTSD in Children', 'orgStudyIdInfo': {'id': 'YS2024CG022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Those who developed PTSD during the follow-up period after enrollment were categorized in the exposu', 'description': 'Those who did not develop PTSD during the follow-up period after enrollment were categorized as control group'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'contacts': [{'name': 'LingXin Wei', 'role': 'CONTACT', 'email': 'weilx3934@sina.com', 'phone': '+8613621159500'}], 'facility': 'The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'LingXin Wei', 'role': 'CONTACT', 'email': 'weilx3934@sina.com', 'phone': '+8613621159500'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'JianHao Zhang', 'class': 'OTHER'}, 'collaborators': [{'name': "Beijing Children's Hospital", 'class': 'OTHER'}, {'name': 'Capital Institute of Pediatrics, China', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'postgraduate student', 'investigatorFullName': 'JianHao Zhang', 'investigatorAffiliation': 'The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College'}}}}