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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 : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Tracking Information
First Submitted Date  ICMJE February 28, 2019
First Posted Date  ICMJE April 29, 2019
Last Update Posted Date July 30, 2020
Actual Study Start Date  ICMJE April 9, 2019
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2019)
  • 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) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Association Between a Peri-traumatic Dissociation State and the Occurrence of Post-traumatic Stress Syndrome
Official Title  ICMJE Study of the Association Between a Peri-traumatic Dissociation State and the Occurrence of Post-traumatic Stress Syndrome After Severe Trauma Requiring General Anesthesia
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Prospective Study
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Severe Trauma
  • General Anaesthesia
Intervention  ICMJE Diagnostic Test: PDEQ, PCL-5 and demographic survey
Questionnaires
Study Arms  ICMJE 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
Intervention: Diagnostic Test: PDEQ, PCL-5 and demographic survey
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 25, 2019)
145
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2020
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Philippe ARIES, Dr 0033298347961 philippe.aries@chu-brest.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03930966
Other Study ID Numbers  ICMJE DIStress-AG (29BRC18.0200)
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party University Hospital, Brest
Study Sponsor  ICMJE University Hospital, Brest
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Philippe ARIES, Dr philippe.aries@chu-brest.fr
PRS Account University Hospital, Brest
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP