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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

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

Clinicaltrials.gov identifier NCT03930966

Recruitment Status Recruiting

First Posted April 29, 2019

Last update posted July 30, 2020

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:Severe Trauma
    General Anaesthesia
  • Intervention/Treatment: Diagnostic Test: PDEQ, PCL-5 and demographic survey
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 145 participants
  • Intervention Model: Single Group Assignment
  • Intervention Model Description: Prospective 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: April 2019
  • Estimated Primary Completion Date: November 2020
  • Estimated Study Completion Date: November 2020
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
Outcome Measures
  • Primary Outcome Measures: 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 [ Time Frame: 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: 1. Measurement of the frequency of PTSD after severe trauma requiring general anesthesia. [ Time Frame: study baseline (6 to 12 months after initial hospitalisation) ]
  • 2. Research of Risk Factors Associated with the Occurrence of PTSD [ Time Frame: study baseline (6 to 12 months after initial hospitalisation) ]
Eligibility Criteria
  • Ages Eligible for Study: (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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

Contacts and Locations
Contacts

Contact: Philippe ARIES, Dr 0033298347961 philippe.aries@chu-brest.fr

Locations

France
CHRU Brest
Brest

Sponsors and Collaborators

University Hospital, Brest

Investigators

Principal Investigator: Philippe ARIES, Dr philippe.aries@chu-brest.fr

More Information
  • Responsible Party: University Hospital, Brest
  • ClinicalTrials.gov Identifier: NCT03930966 History of Changes
  • Other Study ID Numbers: DIStress-AG (29BRC18.0200)
  • First Posted: April 29, 2019 Key Record Dates
  • Last Update Posted: July 30, 2020
  • Last Verified: December 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Yes
  • Plan Description: All collected data that underlie results in a publication
  • Supporting Materials: 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.
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by University Hospital, Brest: Severe trauma
    General anaesthesia
    Peri-traumatic dissociation state
    Post-traumatic stress disorder
  • Additional relevant MeSH terms: Dissociative Disorders
    Stress Disorders, Post-Traumatic
    Wounds and Injuries