Work-Related ConditionEmerg-APoSHeWNCT06492928
Attentionnal Performance of Shift Health Workers in Emergency Department
An observational study of Work-Related Condition, run by Centre Hospitalier de Roubaix at 4 sites in France.
Trial summary
Atypical working hours can be a risk factor for workers. In fact, the body is subject to a circadian rhythm, which affects numerous physiological activities. These biological rhythms reflect the need for certain physiological activities to occur at a specific time of day. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Work-Related Condition
- What is being tested?
- Psychomotor Vigilance Task
- How many people
- 69 participants
- Where
- 4 sitesFrance
- Study dates
- 12 Jun 2024to 30 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: All Health Workers who start their shift during the study duration
Who may be able to join
- Physicians,
- residents,
- nurses,
- nursing assistants
Who cannot join
- Students,
- paramedics
Trial locations and contacts
4 sites in 1 country.
France4 sites
Emergency Department, General Hospital
Armentières, Nord
Emergency Department, General Hospital
Hazebrouck, Nord
Emergency Department, GHICL Saint-Philibert
Lomme, Nord
Emergency Department, General Hospital
Tourcoing, Nord
About this study
Official title: Evaluation of Attentionnal Performance by PVT of Health Workers During Their Shift in Emergency Department
Atypical working hours can be a risk factor for workers. In fact, the body is subject to a circadian rhythm, which affects numerous physiological activities. These biological rhythms reflect the need for certain physiological activities to occur at a specific time of day. This cycle can be disrupted and shifted by external factors. This disruption of biological rhythms can manifest itself in the appearance of health effects.
The innovative nature of our work lies in the search for an alteration in psychomotor functions in nursing staff (subject to atypical working hours). To this end, we decided to study the concentration of care workers using a reflex-based psychomotor test, the Psychomotor Vigilance Test (PVT). Other factors will be studied in order to assess the factors that may affect this test.
Read the detailed description
Population : All care staff in the emergency departments of the participating hospitals: physicians, residents, nurses and nursing assistants.
The main objective is to evaluate concentration in medical/non-medical staff at the start and end of a work shift.
To this end, we will evaluate the Psychomotor Vigilance Test (PVT) and its variation at the start and end of a shift in these personnel.
The endpoint is the difference in reflex time to a visual stimulus performed at the beginning and end of the shift with a 3-minute PVT Test.
The first secondary objective is to analyze the number of PVT errors. The criterion defining an error is a reaction time greater than 500ms.
The second secondary objective is to compare the PVT and its variation in certain subgroups. The subgroups compared will be defined according to the following criteria :
- Shift duration: Non-medical staff (<10h, >10h), Medical staff (6 to 10h, 10 to 15h, 15 to 24h) Staggered shift: start before 6h or end after 22h,
- Type of service: acute care, MCO, SSR (or emergency sector)
- Sleep quality (Pittsburgh Sleep Quality Index),
- Professional fatigue (Maslach Burnout lnventory),
- Anxiety (French official version of the PSS-14),
- Chronotype (Morningness-Eveningness Questionnaire).
- Conditions
- Work-Related Condition
- Being tested
- Psychomotor Vigilance Task
- Keywords
- shift-work, PVT, Health worker, Attentionnal performance, Emergency department
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychomotor Vigilance TaskOther
Also called Maslach Burnout Inventory, Perceived Stress Scale, Pittsburgh Sleep Quality Index, Morningness-Eveningness Questionary
T0 - at the start of the shift: completion of the 1st PVT / socio-demographic and workstation questionnaire T1 - at the end of the shift: completion of the second PVT and questionnaire on the course of the shift that has just taken place T2 - 1 week after the end of the shift: additional questionnaire sent with scales to assess work-related fatigue (MBI), anxiety (PSS), sleep quality (PSQI) and chronotype (MEQ).
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of concentration in medical/non-medical staff at the start and end of a work shift.
To this end, we will evaluate the Psychomotor Vigilance Test (PVT) and its variation at the start and end of a shift in these personnel.
The endpoint is the difference in reflex time to a visual stimulus performed at the beginning and end of the shift with a 3-minute PVT Test.
Measured: Day 1
Secondary outcomes (2)
The first secondary objective is to analyze the number of PVT errors.
The criterion defining an error is a reaction time greater than 500ms.
Measured: Day 1
Sub-group analysis
The second secondary objective is to compare the PVT and its variation in certain subgroups. The subgroups compared will be defined according to the following criteria Shift duration: Non-medical staff (<10h, >10h), Medical staff (6 to 10h, 10 to 15h, 15 to 24h) Staggered shift: start before 6h or end after 22h, Type of service: acute care, MCO, SSR (or emergency sector) Sleep quality (Pittsburgh Sleep Quality Index), Professional fatigue (Maslach Burnout lnventory), Anxiety (French official version of the PSS-14), Chronotype (Morningness-Eveningness Questionnaire).
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start12 Jun 2024
- Primary completion13 Jun 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Work-Related ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Roubaix
- Sponsor type
- University, hospital or other
- Collaborators
- Boulogne sur Mer Hospital Center, Centre Hospitalier de l'Arrondissement de Montreuil-sur-mer, Centre Hospitalier Saint-Omer, Centre Hospitalier de Bethune, Centre Hospitalier de Lens, Polyclinique de la Clarence, Centre hospitalier de Dunkerque, Centre Hospitalier de Douai, Centre Hospitalier de Valenciennes, Centre Hospitalier d'Hazebrouck, Centre Hospitalier de Watrelos, Centre Hospitalier de Denain, Tourcoing Hospital, GHICL, Polyclinique de Grande Synthe
- Responsible party
- Sponsor
- Investigators
- Remy Diesnis, MD, Principal investigator, Centre Hospitalier de Roubaix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06492928
- Sponsor's protocol ID
- 2022-015
- Acronym
- Emerg-APoSHeW
- Status last verified
- Oct 2024
- First submitted
- 25 Jun 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail.; 2016 juin. Report No.: 2011-SA-0088.
Thun E, Bjorvatn B, Torsheim T, Moen BE, Magerøy N, Pallesen S. Night work and symptoms of anxiety and depression among nurses: A longitudinal study. Work Stress. 2 oct 2014;28(4):376 86.
Folkard S, Tucker P. Shift work, safety and productivity. Occup Med (Lond). 2003 Mar;53(2):95-101. doi: 10.1093/occmed/kqg047.
PubMed 12637593
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Attentionnal Performance by PVT of Health Workers During Their Shift in Emergency Department
- ClinicalTrials.gov ID
- NCT06492928
- Acronym / sponsor ID
- Emerg-APoSHeW / 2022-015
- Conditions
- Work-Related Condition
- Keywords
- shift-work, PVT, Health worker, Attentionnal performance, Emergency department
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Centre Hospitalier de RoubaixUniversity, hospital or other
- Collaborators
- Boulogne sur Mer Hospital Center, Centre Hospitalier de l'Arrondissement de Montreuil-sur-mer, Centre Hospitalier Saint-Omer, Centre Hospitalier de Bethune, Centre Hospitalier de Lens, Polyclinique de la Clarence, Centre hospitalier de Dunkerque, Centre Hospitalier de Douai, Centre Hospitalier de Valenciennes, Centre Hospitalier d'Hazebrouck, Centre Hospitalier de Watrelos, Centre Hospitalier de Denain, Tourcoing Hospital, GHICL, Polyclinique de Grande Synthe
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- 13 Jun 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 9 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Atypical working hours can be a risk factor for workers. In fact, the body is subject to a circadian rhythm, which affects numerous physiological activities. These biological rhythms reflect the need for certain physiological activities to occur at a specific time of day. This cycle can be disrupted and shifted by external factors. This disruption of biological rhythms can manifest itself in the appearance of health effects.
The innovative nature of our work lies in the search for an alteration in psychomotor functions in nursing staff (subject to atypical working hours). To this end, we decided to study the concentration of care workers using a reflex-based psychomotor test, the Psychomotor Vigilance Test (PVT). Other factors will be studied in order to assess the factors that may affect this test.
Detailed description
Population : All care staff in the emergency departments of the participating hospitals: physicians, residents, nurses and nursing assistants.
The main objective is to evaluate concentration in medical/non-medical staff at the start and end of a work shift.
To this end, we will evaluate the Psychomotor Vigilance Test (PVT) and its variation at the start and end of a shift in these personnel.
The endpoint is the difference in reflex time to a visual stimulus performed at the beginning and end of the shift with a 3-minute PVT Test.
The first secondary objective is to analyze the number of PVT errors. The criterion defining an error is a reaction time greater than 500ms.
The second secondary objective is to compare the PVT and its variation in certain subgroups. The subgroups compared will be defined according to the following criteria :
- Shift duration: Non-medical staff (<10h, >10h), Medical staff (6 to 10h, 10 to 15h, 15 to 24h) Staggered shift: start before 6h or end after 22h,
- Type of service: acute care, MCO, SSR (or emergency sector)
- Sleep quality (Pittsburgh Sleep Quality Index),
- Professional fatigue (Maslach Burnout lnventory),
- Anxiety (French official version of the PSS-14),
- Chronotype (Morningness-Eveningness Questionnaire).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All Health Workers who start their shift during the study duration
Key inclusion criteria (4 listed)
- Physicians,
- residents,
- nurses,
- nursing assistants
Key exclusion criteria (2 listed)
- Students,
- paramedics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychomotor Vigilance TaskAlso: Maslach Burnout Inventory, Perceived Stress Scale, Pittsburgh Sleep Quality Index, Morningness-Eveningness QuestionaryT0 - at the start of the shift: completion of the 1st PVT / socio-demographic and workstation questionnaire T1 - at the end of the shift: completion of the second PVT and questionnaire on the course of the shift that has just taken place T2 - 1 week after the end of the shift: additional questionnaire sent with scales to assess work-related fatigue (MBI), anxiety (PSS), sleep quality (PSQI) and chronotype (MEQ). | Other | – |
Primary outcome
Evaluation of concentration in medical/non-medical staff at the start and end of a work shift.
Time frame: Day 1
To this end, we will evaluate the Psychomotor Vigilance Test (PVT) and its variation at the start and end of a shift in these personnel. The endpoint is the difference in reflex time to a visual stimulus performed at the beginning and end of the shift with a 3-minute PVT Test.
2 secondary outcomes
The first secondary objective is to analyze the number of PVT errors.
Time frame: Day 1
Sub-group analysis
Time frame: Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Results publicationAgence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail.; 2016 juin. Report No.: 2011-SA-0088.
- Results publicationThun E, Bjorvatn B, Torsheim T, Moen BE, Magerøy N, Pallesen S. Night work and symptoms of anxiety and depression among nurses: A longitudinal study. Work Stress. 2 oct 2014;28(4):376 86.
- Results publication: PubMed 12637593Folkard S, Tucker P. Shift work, safety and productivity. Occup Med (Lond). 2003 Mar;53(2):95-101. doi: 10.1093/occmed/kqg047.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Remy Diesnis, MD principal investigator
Centre Hospitalier de Roubaix
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Work-Related Condition, run by Centre Hospitalier de Roubaix at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of concentration in medical/non-medical staff at the start and end of a work shift. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06492928, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.