NCT06492928

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

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 12, 2024

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2024

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 9, 2024

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

October 16, 2024

Status Verified

October 1, 2024

Enrollment Period

1 day

First QC Date

June 25, 2024

Last Update Submit

October 14, 2024

Conditions

Keywords

shift-workPVTHealth workerAttentionnal performanceEmergency department

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day 1

Secondary Outcomes (2)

  • The first secondary objective is to analyze the number of PVT errors.

    Day 1

  • Sub-group analysis

    Day 7

Interventions

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).

Also known as: Maslach Burnout Inventory, Perceived Stress Scale, Pittsburgh Sleep Quality Index, Morningness-Eveningness Questionary

Eligibility Criteria

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

All Health Workers who start their shift during the study duration

You may qualify if:

  • Physicians,
  • residents,
  • nurses,
  • nursing assistants

You may not qualify if:

  • Students,
  • paramedics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Emergency Department, General Hospital

Armentières, Nord, France

Location

Emergency Department, General Hospital

Hazebrouck, Nord, France

Location

Emergency Department, GHICL Saint-Philibert

Lomme, Nord, France

Location

Emergency Department, General Hospital

Tourcoing, Nord, France

Location

Related Publications (3)

  • Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail.; 2016 juin. Report No.: 2011-SA-0088.

    BACKGROUND
  • 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.

    BACKGROUND
  • Folkard S, Tucker P. Shift work, safety and productivity. Occup Med (Lond). 2003 Mar;53(2):95-101. doi: 10.1093/occmed/kqg047.

    PMID: 12637593BACKGROUND

MeSH Terms

Conditions

Emergencies

Interventions

Maslach Burnout InventoryPerceived Stress Scale

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Remy Diesnis, MD

    Centre Hospitalier de Roubaix

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2024

First Posted

July 9, 2024

Study Start

June 12, 2024

Primary Completion

June 13, 2024

Study Completion

July 30, 2024

Last Updated

October 16, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations