Association Between a Peri-traumatic Dissociation State and the Occurrence of Post-traumatic Stress Syndrome

NCT03930966 | Completed

• 1 other identifier: DIStress-AG (29BRC18.0200)
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Trauma; General Anaesthesia

Keywords

Severe trauma; General anaesthesia; Peri-traumatic dissociation state; Post-traumatic stress disorder

Outcome Measures

Primary Outcomes (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

  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 Outcomes (2)

• 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 Arms (1)

PDEQ, PCL-5 and demographic survey

EXPERIMENTAL

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

Interventions

PDEQ, PCL-5 and demographic survey DIAGNOSTIC_TEST

Questionnaires

PDEQ, PCL-5 and demographic survey

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHRU Brest

Brest, 29200, France

Location

MeSH Terms

Conditions

Wounds and Injuries; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Philippe ARIES, Dr

  philippe.aries@chu-brest.fr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective Study

Study Record Dates

• First Submitted: February 28, 2019
• First Posted: April 29, 2019
• Study Start: April 9, 2019
• Primary Completion: December 15, 2021
• Study Completion: December 15, 2021
• Last Updated: January 5, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

FR (1)