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Completed

NCT Number: NCT03930966

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

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.

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Key information

Conditions

Severe Trauma General Anaesthesia Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU Brest

Brest, 29200, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PDEQ, PCL-5 and demographic survey

Diagnostic Test

Questionnaires

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

    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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study 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

Acronym: DIStress-AG

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 29, 2019
Registry last updated
Jan 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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