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Clinical Trials/NCT03930966
NCT03930966
Completed
Not Applicable

Study of the Association Between a Peri-traumatic Dissociation State and the Occurrence of Post-traumatic Stress Syndrome After Severe Trauma Requiring General Anesthesia

University Hospital, Brest1 site in 1 country148 target enrollmentApril 9, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Severe Trauma
Sponsor
University Hospital, Brest
Enrollment
148
Locations
1
Primary Endpoint
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
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 9, 2019
End Date
December 15, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • Measurement of the frequency of PTSD after severe trauma requiring general anesthesia.(study baseline (6 to 12 months after initial hospitalisation))
  • Research of Risk Factors Associated with the Occurrence of PTSD(study baseline (6 to 12 months after initial hospitalisation))

Study Sites (1)

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