Impact of a Stress Management Training Course (FORSE)

May 4, 2024 updated by: Guillemette Fouquet, Université Paris-Saclay

Evaluating the Impact of a Stress Management Training Course for ECOS Preparation for Medical Students

Objective structured clinical examinations (ECOS) are playing an increasingly important role in the training and assessment of medical students, and now account for 30% of the grade for access to the 3rd cycle of medical studies.

Although students generally seem to have a favorable opinion of this examination modality, several studies have reported that ECOS are a greater source of stress than other types of examination, particularly written examinations.

The investigators aim to assess the benefits of a stress management training for medical students, on the negative impact of stress during ECOS.

The investigators hypothesize that training in stress management could be beneficial for medical students, in particular to prepare them mentally to limit the negative impact of stress durgin ECOS, and ultimately reduce their overall stress and potentially improve their performance.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Objective structured clinical examinations (ECOS) are playing an increasingly important role in the training and assessment of medical students, and now account for 30% of the grade for access to the 3rd cycle of medical studies.

Although students generally seem to have a favorable opinion of this examination modality, several studies have reported that ECOS are a greater source of stress than other types of examination, particularly written examinations.

Anxiety can affect students' performance, although not all studies have found a significant correlation between results and students' state of anxiety.

However, it is essential to take account of students' well-being, especially as it has been shown that medical students suffer from symptoms of anxiety and depression, some of which may be related to their studies.

It is therefore important to reduce these symptoms of anxiety in order to improve students' well-being, and eventually their performance during ECOS.

A number of studies have looked at ways of reducing student anxiety, including breathing relaxation techniques and anxiety management programs. Preparation, stress management and self-confidence can have a calming effect, and may even have a positive impact on exam performance.

The visual analog stress scale and the STAI questionnaire are two validated and commonly used methods for stress assessment. The investigators modified the visual scale to assess the functional impact of stress on ECOS performance.

The investigators hypothesize that training in stress management could be beneficial for medical students, in particular to prepare them mentally to limit the negative impact of stress durgin ECOS, and ultimately reduce their overall stress and potentially improve their performance.

The investigators aim to assess the benefits of a stress management training for medical students, on the negative impact of stress during ECOS.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Medical students from Paris Saclay University, during hospital internships

Description

Inclusion Criteria:

  • Medical students from Paris Saclay University, during hospital internships
  • Agreeing to take part in the study

Exclusion Criteria:

  • Refusal to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Medical students
Medical students from the University of Paris-Saclay, during hospital internships Stress assessement with or without a stress management training
Behavioral: Stress management training
Stress management training

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Functional impact of stress after ECOS
Time Frame: 3 years
Score for the functional impact of stress after ECOS, with or without stress management training From 0 = No negative impact of stress on ECOS performance To 10 = Extremely negative impact of stress on ECOS performance
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Anxiety score
Time Frame: 3 years
Anxiety score on STAI (State and Trait Anxiety Inventory) after ECOS, with or without stress management training From 0 = no anxiety To 40 = very high anxiety
3 years
ECOS scores
Time Frame: 3 years
ECOS scores, with or without stress management training From 0 = lowest score To 10 = highest score
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Université Paris-Saclay

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FORSE_001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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