Back to results

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

Primary Purpose

Severe Trauma, General Anaesthesia

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

PDEQ, PCL-5 and demographic survey

About this trial

This is an interventional prevention trial for Severe Trauma focused on measuring Severe trauma, General anaesthesia, Peri-traumatic dissociation state, Post-traumatic stress disorder

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

CHRU Brest

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PDEQ, PCL-5 and demographic survey

Arm Description

State of the patient evaluated with questionnaires to make the connection between peri-traumatic dissociation and the occurrence of post-traumatic stress disorder

Outcomes

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

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.

Research of Risk Factors Associated with the Occurrence of PTSD

Full Information

NCT ID

NCT03930966

First Posted

February 28, 2019

Last Updated

January 4, 2022

Sponsor

University Hospital, Brest

1. Study Identification

Unique Protocol Identification Number

NCT03930966

Brief Title

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

Acronym

DIStress-AG

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

April 9, 2019 (Actual)

Primary Completion Date

December 15, 2021 (Actual)

Study Completion Date

December 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Brest

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Severe Trauma, General Anaesthesia

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Prospective Study

Masking

None (Open Label)

Allocation

N/A

Enrollment

148 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PDEQ, PCL-5 and demographic survey

Arm Type

Experimental

Arm Description

State of the patient evaluated with questionnaires to make the connection between peri-traumatic dissociation and the occurrence of post-traumatic stress disorder

Intervention Type

Diagnostic Test

Intervention Name(s)

PDEQ, PCL-5 and demographic survey

Intervention Description

Questionnaires

Primary Outcome Measure Information:

Title

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

Description

Time Frame

study baseline (6 to 12 months after initial hospitalisation)

Secondary Outcome Measure Information:

Title

Measurement of the frequency of PTSD after severe trauma requiring general anesthesia.

Time Frame

study baseline (6 to 12 months after initial hospitalisation)

Title

Research of Risk Factors Associated with the Occurrence of PTSD

Time Frame

study baseline (6 to 12 months after initial hospitalisation)

10. Eligibility

Sex

All

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philippe ARIES, Dr

Organizational Affiliation

philippe.aries@chu-brest.fr

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHRU Brest

City

Brest

ZIP/Postal Code

29200

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Learn more about this trial

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

We'll reach out to this number within 24 hrs