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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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 145 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective Study
Masking: None (Open Label)
Primary Purpose: Prevention
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


Arm Intervention/treatment
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
Questionnaires




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Measurement of the frequency of PTSD after severe trauma requiring general anesthesia. [ Time Frame: study baseline (6 to 12 months after initial hospitalisation) ]
  2. Research of Risk Factors Associated with the Occurrence of PTSD [ Time Frame: study baseline (6 to 12 months after initial hospitalisation) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Time between trauma and general anesthesia should not exceed 48 hours
  • Patient agreeing to participate in the study.

Exclusion Criteria:

  • Minor patients
  • Patients under curatorship, and tutorship
  • Patient deprived of liberty
  • Patients who do not speak French
  • Patients who are not in satisfactory neurological state to answer the questionnaire (pyschotic, demented states)
  • Patients who have been sedated (apart from general anesthesia) when receiving or having a Glasgow score <14

Information from the National Library of Medicine

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


Contacts
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Contact: Philippe ARIES, Dr 0033298347961 philippe.aries@chu-brest.fr

Locations
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France
CHRU Brest Recruiting
Brest, France, 29200
Contact: Philippe ARIES, Dr    0033298347961    philippe.aries@chu-brest.fr   
Sponsors and Collaborators
University Hospital, Brest
Investigators
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Principal Investigator: Philippe ARIES, Dr philippe.aries@chu-brest.fr
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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03930966    
Other Study ID Numbers: DIStress-AG (29BRC18.0200)
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected data that underlie results in a publication
Supporting Materials: Study Protocol
Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
Access Criteria: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Brest:
Severe trauma
General anaesthesia
Peri-traumatic dissociation state
Post-traumatic stress disorder
Additional relevant MeSH terms:
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Dissociative Disorders
Stress Disorders, Post-Traumatic
Wounds and Injuries
Mental Disorders
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders