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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03264469
Other study ID # LOISEAU 2016
Secondary ID
Status Completed
Phase N/A
First received August 25, 2017
Last updated September 18, 2017
Start date September 2016
Est. completion date May 2017

Study information

Verified date September 2017
Source Centre Hospitalier Universitaire Dijon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date May 2017
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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:

- 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHU Dijon Bourgogne Dijon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary PID scale At baseline