Severe TraumaDIStress-AGNCT03930966
Association Between a Peri-traumatic Dissociation State and the Occurrence of Post-traumatic Stress Syndrome
A study testing PDEQ, PCL-5 and demographic survey in people with Severe Trauma and General Anaesthesia, run by University Hospital, Brest at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Severe Trauma, General Anaesthesia
- What is being tested?
- PDEQ, PCL-5 and demographic survey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteFrance
- Study dates
- 9 Apr 2019to 15 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Severe Trauma, General Anaesthesia
- Being tested
- PDEQ, PCL-5 and demographic survey
- Keywords
- Severe trauma, General anaesthesia, Peri-traumatic dissociation state, Post-traumatic stress disorder
- Medical subject headings
- Wounds and Injuries, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDEQ, PCL-5 and demographic surveyDiagnostic test
Questionnaires
| Study group | Role | What they receive |
|---|---|---|
| PDEQ, PCL-5 and demographic survey | Experimental | State of the patient evaluated with questionnaires to make the connection between peri-traumatic dissociation and the occurrence of post-traumatic stress disorder Receives: Diagnostic Test: PDEQ, PCL-5 and demographic survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: study baseline (6 to 12 months after initial hospitalisation)
Secondary outcomes (2)
Measurement of the frequency of PTSD after severe trauma requiring general anesthesia.
Measured: study baseline (6 to 12 months after initial hospitalisation)
Research of Risk Factors Associated with the Occurrence of PTSD
Measured: study baseline (6 to 12 months after initial hospitalisation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start9 Apr 2019
- Primary completion15 Dec 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective Study
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe ARIES, Dr, Principal investigator, philippe.aries@chu-brest.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03930966
- Sponsor's protocol ID
- DIStress-AG (29BRC18.0200)
- Acronym
- DIStress-AG
- Status last verified
- Sep 2021
- First submitted
- 28 Feb 2019
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03930966
- Acronym / sponsor ID
- DIStress-AG / DIStress-AG (29BRC18.0200)
- Conditions
- Severe Trauma, General Anaesthesia
- Keywords
- Severe trauma, General anaesthesia, Peri-traumatic dissociation state, Post-traumatic stress disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 29 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective Study
| Arm | Type | Receives |
|---|---|---|
| PDEQ, PCL-5 and demographic survey | Experimental | Diagnostic Test: PDEQ, PCL-5 and demographic surveyState of the patient evaluated with questionnaires to make the connection between peri-traumatic dissociation and the occurrence of post-traumatic stress disorder |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PDEQ, PCL-5 and demographic surveyQuestionnaires | Diagnostic test | PDEQ, PCL-5 and demographic survey |
Primary outcome
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.
2 secondary outcomes
Measurement of the frequency of PTSD after severe trauma requiring general anesthesia.
Time frame: study baseline (6 to 12 months after initial hospitalisation)
Research of Risk Factors Associated with the Occurrence of PTSD
Time frame: study baseline (6 to 12 months after initial hospitalisation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe ARIES, Dr principal investigator
philippe.aries@chu-brest.fr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PDEQ, PCL-5 and demographic survey in people with Severe Trauma and General Anaesthesia, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2022; AzTrials last refreshed its copy on 31 Oct 2026.