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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05393206
Other study ID # Cope&stress
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 16, 2022
Est. completion date December 19, 2023

Study information

Verified date June 2024
Source Claude Bernard University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Objective structured clinical examinations (OSCEs) have recently been incorporated in the French medical studies. They will soon be an important part of the national evaluation of the students, therefore being responsible for a high level of stress. The differents strategies of coping have never been characterized for this particular group of students. We hypothetize that different strategies of coping are associated with different level of stress, thus being an interesting insight to help students to deal with their stress and prevent disorders linked to stress. We will be using the Brief Cope Scale to assess the different ways of coping, in addition to multiple demographic and health-related questionnaires.


Description:

This observational study will be conducted between the 17th and 19th of May at the Claude Bernard University (Lyon, France), during the OSCEs of the 4th year medical students. Their signed consent will be required before inclusion to the study. Before the test begin, they will be given a few questionnaires to fill, including the Brief Cope Scale, visual analogous scales of their level of stress, level of confidence and level of resourcefulness. Coping methods are categorized in 4 types : positive thinking, active resolution, social support and avoidance. We will also ask them about their physical activity and their quality of sleep prior the OSCEs. After the test, we will ask them once again their level of stress (visual analogous scale). The main objective of this study is to demonstrate the link between the different methods of coping and the level of stress on the day of the OSCEs. Secondary objective is to have better insight and understanding over the relationship between coping methods and health-related problematics when linked to anxiety generated by exams. All these data will be compared to a previous similar study conducted by our team of investigators on the same group of students, during their academical OSCEs in december 2021 (ECOSTRESS).


Recruitment information / eligibility

Status Completed
Enrollment 490
Est. completion date December 19, 2023
Est. primary completion date June 19, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Fourth year medical student of Claude Bernard University participating to the OSCEs of May 2022 Exclusion Criteria: - No signed consent

Study Design


Locations

Country Name City State
France Claude Bernard University Lyon

Sponsors (1)

Lead Sponsor Collaborator
Claude Bernard University

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Brief cope scale Brief Cope Scale level (from 2: minimum to 8 points : maximum) on the day of the OSCE measured in the half-hour prior to the OSCEs
Secondary Coping and characterisation of stress Correlation between coping methods according to BCS and characterisation of stress (from negative to positive, visual analogous scale) on the day of the OSCE measured in the half-hour prior to the OSCEs
Secondary Coping and self-confidence Correlation between coping methods according to BCS and the level of confidence (visual scale) on the day of the OSCE measured in the half-hour prior to the OSCEs
Secondary Coping and inner resources Correlation between coping methods according to BCS and the level of resourcefulness (visual scale) on the day of the OSCE (Spearman method) measured in the half-hour prior to the OSCEs
Secondary Coping and physical activity Correlation between coping methods according to BCS and the level of physical activity assessed by the GPAQ questionnaire (Global Physical Activity Questionnaire) in time of physical activity (minutes) measured in the half-hour prior to (BCS) and in the half-hour after (GPAQ) the OSCEs
Secondary Coping and sleep quality Correlation between coping methods according to BCS and the score of sleep quality assesed by the PSQI questionnaire (Pittsburgh Sleep Quality Inventory) measured in the half-hour prior to (BCS) and in the half-hour after (Pittsburgh Sleep Quality Index (PSQI from 0 minimum to 21 maximum)) the OSCEs
Secondary Link between sleep quality and stress Correlation between score of sleep quality assesed by the PSQI questionnaire (Pittsburgh Sleep Quality Inventory) and the level of stress (visual analogous scale) on the day of the OSCE measured in the half-hour prior to (stress level) and in the half-hour after (PSQI) the OSCEs
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