Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-01-26 @ 10:20 PM
Study NCT ID:
NCT03930966
Status:
COMPLETED
Last Update Posted:
2022-01-05
First Post:
2019-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association Between a Peri-traumatic Dissociation State and the Occurrence of Post-traumatic Stress Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective Study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-04', 'studyFirstSubmitDate': '2019-02-28', 'studyFirstSubmitQcDate': '2019-04-25', 'lastUpdatePostDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Studying association between the presence of peri-traumatic dissociation state and the achievement of post-traumatic stress disorder between 6 and 12 months in traumatized patients', 'timeFrame': 'study baseline (6 to 12 months after initial hospitalisation)', 'description': 'Association will be measured using PDEQ scale and PCL-5 scale. The peri-traumatic dissociation will be evaluated by the Peri-traumatique Dissociation Experience Questionnary (PDEQ scale). This questionnaire contains ten items to study the presence or not of a peri-traumatic dissociation state. The items are scored on a 5-point Likert scale ranging from 1 (not at all true) to 5 (extremely true). The total score is the sum of all the items. A score from 15 indicates a significant dissociation.\n\nThe presence or not of a Post-Traumatic Stress Disorder (PTSD) will be evaluated by the Post-Traumatic Stress Disorder Checklist Scale-Version DSM 5 (PCL-5). This questionnaire contains twenty items to study the presence or not of a PTSD. A total score for symptom severity (0-80) can be obtained by summing the scores for each of the 20 items. A score over 31 indicates a PTSD.'}], 'secondaryOutcomes': [{'measure': 'Measurement of the frequency of PTSD after severe trauma requiring general anesthesia.', 'timeFrame': 'study baseline (6 to 12 months after initial hospitalisation)'}, {'measure': 'Research of Risk Factors Associated with the Occurrence of PTSD', 'timeFrame': 'study baseline (6 to 12 months after initial hospitalisation)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Severe trauma', 'General anaesthesia', 'Peri-traumatic dissociation state', 'Post-traumatic stress disorder'], 'conditions': ['Severe Trauma', 'General Anaesthesia']}, 'descriptionModule': {'briefSummary': 'Patients will be selected after studying clinical records.Patients who had general anesthesia due to an injury related to severe trauma within 6 to 12 months prior to inclusion will be included.\n\nThree self-survey will be completed by the patient: PDEQ, PCL-5 and a demographic questionnaire. According to the PDEQ and PCL-5 scores, an association between a peri-traumatic dissociation state and a post-traumatic stress disorder can be established.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with general anesthesia for a surgical wound with violent trauma in the road, a fall of more than 6 meters, burn, accident at work, explosion, aggression) in the 6 to 12 months before the inclusion\n* Time between trauma and general anesthesia should not exceed 48 hours\n* Patient agreeing to participate in the study.\n\nExclusion Criteria:\n\n* Minor patients\n* Patients under curatorship, and tutorship\n* Patient deprived of liberty\n* Patients who do not speak French\n* Patients who are not in satisfactory neurological state to answer the questionnaire (pyschotic, demented states)\n* Patients who have been sedated (apart from general anesthesia) when receiving or having a Glasgow score \\<14'}, 'identificationModule': {'nctId': 'NCT03930966', 'acronym': 'DIStress-AG', 'briefTitle': 'Association Between a Peri-traumatic Dissociation State and the Occurrence of Post-traumatic Stress Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Study of the Association Between a Peri-traumatic Dissociation State and the Occurrence of Post-traumatic Stress Syndrome After Severe Trauma Requiring General Anesthesia', 'orgStudyIdInfo': {'id': 'DIStress-AG (29BRC18.0200)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PDEQ, PCL-5 and demographic survey', 'description': 'State of the patient evaluated with questionnaires to make the connection between peri-traumatic dissociation and the occurrence of post-traumatic stress disorder', 'interventionNames': ['Diagnostic Test: PDEQ, PCL-5 and demographic survey']}], 'interventions': [{'name': 'PDEQ, PCL-5 and demographic survey', 'type': 'DIAGNOSTIC_TEST', 'description': 'Questionnaires', 'armGroupLabels': ['PDEQ, PCL-5 and demographic survey']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29200', 'city': 'Brest', 'country': 'France', 'facility': 'CHRU Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}], 'overallOfficials': [{'name': 'Philippe ARIES, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'philippe.aries@chu-brest.fr'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be available after the publication of result and ending fifteen years following the last visit of the last patient', 'ipdSharing': 'YES', 'description': 'All collected data that underlie results in a publication', 'accessCriteria': 'Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}