Association Between a Peri-traumatic Dissociation State and the Occurrence of Post-traumatic Stress Syndrome (DIStress-AG)

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

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.

Study Overview

• Status: Completed
• Conditions: General Anaesthesia; Severe Trauma
• Intervention / Treatment: Diagnostic test: PDEQ, PCL-5 and demographic survey

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Brest, France, 29200
    • CHRU Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	study baseline (6 to 12 months after initial hospitalisation)

Secondary Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Investigators: Principal Investigator: Philippe ARIES, Dr, philippe.aries@chu-brest.fr

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2019
• Primary Completion (Actual): December 15, 2021
• Study Completion (Actual): December 15, 2021

Study Registration Dates

• First Submitted: February 28, 2019
• First Submitted That Met QC Criteria: April 25, 2019
• First Posted (Actual): April 29, 2019

Study Record Updates

• Last Update Posted (Actual): January 5, 2022
• Last Update Submitted That Met QC Criteria: January 4, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: General anaesthesia; Post-traumatic stress disorder; Severe trauma; Peri-traumatic dissociation state
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Wounds and Injuries; Dissociative Disorders
• Other Study ID Numbers: DIStress-AG (29BRC18.0200)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No