NCT03353805

Brief Summary

The terrorist attack on the ram truck, which occurred on 14 July 2016 on the Promenade des Anglais in Nice, involved a significant number of casualties in the civilian population: 86 dead including 10 children and adolescents, and 434 wounded. The attack harmed families gathered for a festive event, the national holiday fireworks, and affected both adults and children of all ages. The people directly involved in the attack number in the thousands: wounded, threatened with death, bereaved, direct witnesses, workers - including firefighters and health personnel (in situations of prolonged extreme tension or insecurity). Following the attacks in Ile-de-France in January and November 2015, Public Health France conducted in 2015 and 2016 two large-scale studies to estimate the psycho-traumatic impact for those involved in the attack, to know the use of care devices to provide useful information, and ultimately provide information to improve the management devices in place. IMPACTS carried out following the attacks of January, ESPA 13 November carried out following the attacks of 13 November 2015, relate to two main types of population:

  • Non-responders (civilian population) present on or near scenes of crime or their relatives.
  • Persons intervened to secure the premises or provide assistance, or provide psychological support the same day or within 3 weeks. IMPACTS was conducted face-to-face with investigators and concerned 232 participants, 45 people of the medico-psychological relief (Samu, Cump, Hôtel Dieu) between 6 and 10 months after the events. A second wave of interviews took place from 16 to 20 months after the events. ESPA 13th November took place via a web-based questionnaire and 800 participants took part, including 67 CUMPs, 121 hospital staff and 26 people from Samu between 9 and 12 months after the events. Based on the expertise of Public Health France and the model developed for the ESPA study on November 13th, the Public Health Department of the University Hospital of Nice wished to carry out a specific study among the health professionals of the University Hospital of Nice and the Hospitals pediatrics of Nice CHU-Lenval, as well as students of the Faculty of Medicine of Nice Sophia-Antipolis. Many professionals of all categories were directly impacted: either at the scene of the attack as a civilian population or as professionals, or in the care services that received the victims and families (including services of the Pasteur2 hospital, Lenval Hospital on the Promenade des Anglais). The population of medical students is also included in the study, and external students in particular have made a significant contribution to the Institut Médico-Légal. This involvement could be done directly (presence as hospital staff at the scene of the attack, care of the victims or their relatives, in the emergency and care services), but also indirect (close and knowledge affected by the attack, specific repercussions in the local context, forced changes in the organization of work). It is therefore all hospital professionals, medical students (external, internal) and paramedical students who will be involved in the study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
804

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2017

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 27, 2017

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

November 17, 2017

Last Update Submit

March 20, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • questionnaire about health impact

    document the health impact of these events and provide useful information for the care arrangements for the populations involved and in the event of a new attack.

    1 year

Interventions

questionnaireBEHAVIORAL

questionnaire

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The staff * From the establishments of the Nice University Hospital: Hôpital Pasteur, Hôpital l' Archet, Hôpital de Cimiez, Hôpital St Roch, Unité centrale de production or UCP, Hôpital de Tende. * From the Lenval Hospital building: staff of the Nice CHU-Lenval Children's Hospital, and staff of the Lenval Foundation. * Students (external from M1 onwards, i. e. the 4th year, and interns) enrolled in Nice-Sophia Antipolis Faculty of Medicine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nice Hospital

Nice, 06000, France

Location

Related Publications (1)

  • Bentz L, Pirard P, Motreff Y, Vandentorren S, Baubet T, Fabre R, Touboul Lundgren P, Pradier C. Health outcomes of the July 14, 2016 Nice terror attack among hospital-based professionals and students: the << ECHOS de Nice >> health survey protocol. BMC Public Health. 2019 Aug 23;19(1):1163. doi: 10.1186/s12889-019-7489-3.

MeSH Terms

Conditions

Mental DisordersPsychological Trauma

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2017

First Posted

November 27, 2017

Study Start

June 20, 2017

Primary Completion

October 31, 2017

Study Completion

October 31, 2019

Last Updated

March 24, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations