Association Between a Peri-traumatic Dissociation State and the Occurrence of Post-traumatic Stress Syndrome (DIStress-AG)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03930966|
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : July 30, 2020
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 :||November 30, 2020|
|Estimated Study Completion Date :||November 30, 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) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03930966
|Contact: Philippe ARIES, Dremail@example.com|
|Brest, France, 29200|
|Contact: Philippe ARIES, Dr 0033298347961 firstname.lastname@example.org|
|Principal Investigator:||Philippe ARIES, Dremail@example.com|