Association Between a Peri-traumatic Dissociation State and the Occurrence of Post-traumatic Stress Syndrome (DIStress-AG)
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|ClinicalTrials.gov Identifier: NCT03930966|
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : December 13, 2019
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.
Three 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.
|Condition or disease||Intervention/treatment||Phase|
|Severe Trauma General Anaesthesia||Diagnostic Test: PDEQ, PCL-5 and demographic survey||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||145 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective Study|
|Masking:||None (Open Label)|
|Official Title:||Study of the Association Between a Peri-traumatic Dissociation State and the Occurrence of Post-traumatic Stress Syndrome After Severe Trauma Requiring General Anesthesia|
|Actual Study Start Date :||April 9, 2019|
|Estimated Primary Completion Date :||April 9, 2020|
|Estimated Study Completion Date :||April 9, 2020|
Experimental: PDEQ, PCL-5 and demographic survey
State of the patient evaluated with questionnaires to make the connection between peri-traumatic dissociation and the occurrence of post-traumatic stress disorder
Diagnostic Test: PDEQ, PCL-5 and demographic survey
- 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 [ Time Frame: study baseline (6 to 12 months after initial hospitalisation) ]
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.
The 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.
- Measurement of the frequency of PTSD after severe trauma requiring general anesthesia. [ Time Frame: study baseline (6 to 12 months after initial hospitalisation) ]
- Research of Risk Factors Associated with the Occurrence of PTSD [ Time Frame: study baseline (6 to 12 months after initial hospitalisation) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03930966
|Contact: Philippe ARIES, Drfirstname.lastname@example.org|
|Brest, France, 29200|
|Contact: Philippe ARIES, Dr 0033298347961 email@example.com|
|Principal Investigator:||Philippe ARIES, Drfirstname.lastname@example.org|