NCT06907030

Brief Summary

Since May 2024, New Caledonia has been experiencing a period of crisis. The organisation of the work of military personnel on the ground has been heavily impacted, with longer working hours, shorter rest periods and increased stress levels (uncertainty about the situation, lack of visibility, etc.). Prolonged exposure to stress is accompanied by neuronal damage (Ramdani et al., 2024) and operational fatigue, a mindset that results from reversible neuronal damage and appears to be distinct from exhaustion. The aim of this study is to assess the impact of the crisis on the level of operational fatigue. In addition, identifying the organisational and human factors (Jaspers et al., 2024) that may have been protective against operational fatigue could help to optimise the way in which these factors are taken into account in the event of future crises, in order to promote resilience.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 2, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

April 3, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

April 9, 2025

Status Verified

April 1, 2025

Enrollment Period

3 months

First QC Date

March 13, 2025

Last Update Submit

April 7, 2025

Conditions

Keywords

operational wear and tearresilienceorganisational and human factorpsychosocial risk

Outcome Measures

Primary Outcomes (1)

  • Assessing operational wear and tear linked to the crisis

    Difference in the Burn-out Assesment Tool (Schaufeli et al., 2019) questionnaire score between exposed and control groups. This questionnaire consists of 23 items, each scored from 1 to 5. The sum of the scores for each item is then divided by 23 to give a final score of between 1 and 5. Subjects can then be classified as green (score \< 2.59), orange (2.59 to 3.02) and red (score \>3.02). The questionnaire contains sub-scores for 'exhaustion', 'mental distance', 'cognitive impairment', 'emotional impairment', 'psychological complaints' and 'psychosomatic complaints'.

    the questionnaire will be completed by the military in April 2025, i.e. 23 months after the start of the crisis for the exposed group

Secondary Outcomes (3)

  • Assessing the impact of the crisis on Burn-out Assesment Tool sub-scores

    Military personnel will complete the questionnaires in April 2025 and June 2025, i.e. there will be a two-month gap between the two sessions.

  • Assessing the benefits of raising awareness of organisational and human factors on operational wear and tear

    Military personnel will complete the questionnaires in April 2025 and June 2025, i.e. there will be a two-month gap between the two sessions.

  • Determining the protective and vulnerability factors (such as Psychosocial Risks) to operational wear and tear

    Military personnel will complete the questionnaires in April 2025

Study Arms (2)

exposed group

Exposed group is the group of military personnel present in New Caledonia at the start of the crisis, i.e. in May 2024, and still posted to New Caledonia at the time of the study, i.e. in April 2025.

Other: No intervention

control group

Control group is the group of military personnel not present in New Caledonia at the start of the crisis, i.e. in May 2024, posted to New Caledonia in the summer of 2024 and present at the time of the study, i.e. in April 2025.

Interventions

No intervention

exposed group

Eligibility Criteria

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

Serving military personnel aged between 18 and 65 posted to New Caledonia at the time of the study, i.e. between April and July 2025.

You may qualify if:

  • be a member of the military
  • be permanently posted to NC at the time of the study

You may not qualify if:

  • Be on temporary assignment in NC at the time of the study
  • Subjects covered by articles L1121-5 to 1121-8 of the Public Health Code, i.e. :
  • Pregnant women, women in labour and nursing mothers
  • Persons deprived of their liberty by judicial or administrative decision
  • Persons subject to psychiatric monitoring under articles L3212-1 and L3213-1 who are not covered by the provisions of article L1121-8
  • Persons of full age who are the subject of a legal protection measure or who are unable to express their consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NOUMEA

Noumea, France

RECRUITING

Related Publications (5)

  • Jaspers GJ, Borsci S, van der Hoeven JG, Kuijer-Siebelink W, Lemson J. Escape room design in training crew resource management in acute care: a scoping review. BMC Med Educ. 2024 Jul 30;24(1):819. doi: 10.1186/s12909-024-05753-z.

    PMID: 39080688BACKGROUND
  • Kristensen TS, Hannerz H, Hogh A, Borg V. The Copenhagen Psychosocial Questionnaire--a tool for the assessment and improvement of the psychosocial work environment. Scand J Work Environ Health. 2005 Dec;31(6):438-49. doi: 10.5271/sjweh.948.

    PMID: 16425585BACKGROUND
  • Ramdani C, Desruelle AV, Vallee N, Ogier M. Neurofilament-light: Impact of chronic stress on brain. Rev Neurol (Paris). 2024 Dec;180(10):1139-1141. doi: 10.1016/j.neurol.2024.08.001. Epub 2024 Sep 10. No abstract available.

    PMID: 39261122BACKGROUND
  • Schaufeli WB, Desart S, De Witte H. Burnout Assessment Tool (BAT)-Development, Validity, and Reliability. Int J Environ Res Public Health. 2020 Dec 18;17(24):9495. doi: 10.3390/ijerph17249495.

    PMID: 33352940BACKGROUND
  • Klein O., Marchal C. et Van der Linden N. (2008). L'analyse de médiation en psychologie sociale expérimentale : une introduction non technique. Revue électronique de Psychologie Sociale, n°2, pp. 53-62

    BACKGROUND

MeSH Terms

Conditions

Lacerations

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

March 13, 2025

First Posted

April 2, 2025

Study Start

April 3, 2025

Primary Completion

July 1, 2025

Study Completion

April 1, 2026

Last Updated

April 9, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations