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CompletedNCT03264469PSYCHICUpdated Sep 19, 2017

Improvement of the Diagnosis and Medico-legal Management of Psychological Trauma in Patients Involved in the Terrorist Attack in Nice on the 14th July 2016

An observational study in Registration of a Complaint Following the Terrorist Attack of 14 July 2016, sponsored by Centre Hospitalier Universitaire Dijon. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2017-09-19.

Sponsored by Centre Hospitalier Universitaire Dijon · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Sex
All
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Study summary

Psychological trauma is a major public health concern that affects numerous patients who have experienced traumatic events.

The objective of our research was to improve the diagnosis and management of persons experiencing such events.

We will seek to determine factors brought into play in the construction of psychological trauma and the best way to identify them so as to implement the optimal management of patients and ensure recognition of this condition.

In addition, in the context of our activity as expert witnesses, we will study the methods used to assess and quantify psychological trauma.

In this respect, a medical appointment will be made by a nurse of the Forensic Medicine Department of Dijon CHU. During this consultation, a self-report questionnaire will be completed by the patient alone to evaluate the level of acute stress followed by a psychiatric consultation and completion of the IES-R questionnaire with the doctor to identify symptoms of psychological trauma.

02

Conditions studied

  • Registration of a Complaint Following the Terrorist Attack of 14 July 2016

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03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Registration of a complaint following the terrorist attack of 14 July 2016

Inclusion criteria

  • Patients who have registered a complaint leading to the involvement of the Forensic Medicine Department of DIJON CHU to evaluate requests for temporary sick leave for psychological reasons following the event in NICE on the 14 July 2016.

Exclusion criteria

Exclusion Criteria:

  • Refusal of the patient to attend the consultation proposed by the Forensic Medicine Department of DIJON CHU,
  • Refusal of the patient to take part in a clinical study.
  • Verbal information about the clinical study when the appointment was made by the Forensic Medicine nurse,
  • Reiteration of the verbal information during the consultation,
  • A letter and an official information document given to each patient by the DIJON CHU research Unit stating the objectives and methods of the clinical study,
  • Contact details of the Forensic Medicine Department given to patients if they have any questions about the study.
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. PID scale

    Time frame: At baseline

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Study locations

1 site
  • CHU Dijon Bourgogne
    Dijon, 21079, France
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Registry details

Key details

Study ID
NCT03264469
Lead sponsor
Centre Hospitalier Universitaire Dijon
Responsible party
Sponsor
First posted
Aug 29, 2017
Start date
Sep 2016
Primary completion
May 2017
Completion
May 2017
Last update
Sep 19, 2017

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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