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

Sponsor

University Hospital, Brest (Other)

Overall Status

Completed

CT.gov ID

NCT03930966

Collaborator

(none)

148

Enrollment

Location

Arm

32.2

Actual Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

148 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Prospective StudyProspective 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 :

Apr 9, 2019

Actual Primary Completion Date :

Dec 15, 2021

Actual Study Completion Date :

Dec 15, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 [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

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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