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

General Anaesthesia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03930966
• Other study ID #: DIStress-AG (29BRC18.0200)
• Status: Completed
• Phase: N/A
• Start date: April 9, 2019
• Est. completion date: December 15, 2021

Study information

• Verified date: September 2021
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: December 15, 2021
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Dissociative Disorders
• General Anaesthesia
• Severe Trauma
• Stress Disorders, Post-Traumatic
• Wounds and Injuries

Intervention

Diagnostic Test:
• PDEQ, PCL-5 and demographic survey
Questionnaires

Locations

Country	Name	City	State
France	CHRU Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Measurement of the frequency of PTSD after severe trauma requiring general anesthesia.		study baseline (6 to 12 months after initial hospitalisation)
Secondary	Research of Risk Factors Associated with the Occurrence of PTSD		study baseline (6 to 12 months after initial hospitalisation)