- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06907030
Wear and Tear on Military Personnel Post Caledonian Crisis (U-CARE)
Evaluation of Operational Wear and Tear Related to the Caledonian Crisis on Military Personnel
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Military personnel face specific operational constraints related to their activity. These constraints require physiological adaptation, which can lead to overall biological wear and tear. In our case, the term 'operational wear and tear' refers to the mindset or mental state induced by operational constraints and the chronic stress they impose.
The soldiers deployed in New Caledonia since the riots in May 2024 have had to cope with operational constraints linked to their job, as well as those linked to the insurrection situation. By modifying the physical constraints (longer working hours, less sleep, etc.) and psychological constraints (for example, the unknown duration of the crisis), the current crisis in New Caledonia may have increased operational wear and tear.
The investigators hypothesise that soldiers present in New Caledonia when the riots began have accumulated additional stress related to the crisis and that this could result in greater operational wear and tear than soldiers transferred to New Caledonia in the summer of 2024. However, it is possible that the stress of moving to New Caledonia will counterbalance this effect. For this reason, the study is being conducted over 2 months, in order to assess the evolutionary profile of operational wear and tear.
This is a single-centre observational study of healthy military personnel in New Caledonia. Subjects will be volunteers and their participation or non-participation will not influence their ability to serve, their promotion or their career. Their superiors will not be informed of their participation or non-participation.
Military personnel will be given an oral presentation of the study. On this occasion, the information note will be distributed to them. If they are volunteers, they will have an inclusion visit, notify their non-objection and fill in the first questionnaire. Between two months later, they will complete the second questionnaire.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: celine ramdani, MD
- Phone Number: 0662194297
- Email: celineramdani@hotmail.fr
Study Contact Backup
- Name: rachel haus, MD
- Phone Number: 0140514801
- Email: rachel.haus@intradef.gouv.fr
Study Locations
-
-
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Noumea, France
- Recruiting
- NOUMEA
-
Contact:
- RAMDANI C MD
- Phone Number: +33662194297
- Email: celineramdani@hotmail.fr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- be a member of the military
- be permanently posted to NC at the time of the study
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessing operational wear and tear linked to the crisis
Time Frame: 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
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessing the impact of the crisis on Burn-out Assesment Tool sub-scores
Time Frame: 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.
|
Comparison of variations in Burn-out Assesment Tool sub-scores (Schaufeli et al., 2020) between the 'exposed' and 'unexposed' groups and the first and second questionnaire two month later.
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'.
|
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.
|
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Assessing the benefits of raising awareness of organisational and human factors on operational wear and tear
Time Frame: 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.
|
Comparison of variations of the scores of the Burn-out Assesment Tool between the group sensitised to organisational and human factors and the group not sensitised to organisational and human factor on the first and second questionnaires. 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'. |
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
Time Frame: Military personnel will complete the questionnaires in April 2025
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Search for correlations between scores on the Copenhagen Psychosocial Questionnaire (Kristensen et al., 2005) and Burn-out Assesment Tool scores.
Burn-out Assesment Tool 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 Copenhagen Psychosocial Questionnaire consists of 22 items, each scored from 1 to 5. The sum of the scores for each item is then divided by 22 to give a final score of between 1 and 5. 1 is the best outcome, 5 is the worth outcome.
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Military personnel will complete the questionnaires in April 2025
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Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024PPRC08
- 2024-A02433-44 (Other Identifier: (IDRCB))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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