Preventive Remediation of Stress for Optimal MEdical StudentS

NCT ID: NCT06295133

Last Updated: 2024-03-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-11
• Study Completion Date: 2024-09-30

Brief Summary

Medical students are subjected to a high competitive pressure throughout their curriculum. High levels of stress are associated with a deterioration in quality of life and learning abilities.

Our field surveys conducted in 2022 and 2023 at the Lyon Est Medical School revealed that second-cycle students presented a high level of stress. It is expected that these feelings significantly degrade their quality of life as well as their health. Furthermore, a local survey reported that one in two medical students had experienced at least one depressive episode, and one in three had already had suicidal thoughts during their curriculum.

Thus, it would become crucial for medical students to manage stressful situations and reduce stress levels during their studies.

The PROMESS - STRESS project aims to offer solutions to students to reduce their stress levels during their medical studies. It responds to a demand expressed by students : our previous field study showed that 45% of fourth-year students declared being "very interested" and/or "interested" in following a intervention aimed at stress reduction. An early knowledge of stress remediation tools would allow students to quickly acquire the necessary tools to cope with stressful situations they will encounter during their training and their life as future physicians. The objective of this study is to determine the influence of a stress management intervention on medical students levels of psychophysiological stress and satisfaction.

Detailed Description

Our project aims to support future healthcare professionals to adopt health-promoting behaviors during their studies in a preventive approach. This support will be provided through an intervention of stress management during their curriculum. Specifically, 4th and 5th-year students of the Faculty of Medicine of Lyon Est will have the opportunity to participate in the PROMESS STRESS project. 45 voluntaries will follow a preventive program based on stress management. This intervention will span 11 weeks. At the end of this period, we expect improvements in both subjective and objective indicators of stress.

METHODS.

PRE-INTERVENTION. Week 1. Participants will undergo a two-hour session, during which, they will complete questionnaires on stress. We will also record Heart Rate Variability (HRV).

INTERVENTION. From week 5 to week 11. The stress management intervention will consist of three individual sessions, each lasting one hour, with approximately 15 days between each session. Each session includes individual interviews between a stress expert and the participant (i.e. student).

The sessions will be scheduled as follow: week 5 and 6 (session 1), week 7 and 8 (session 2), week 9, 10, and 11 (session 3). During the interview, the expert realizes an initial assessment of student stress levels and gives personalized goals to student. Subsequent sessions follow the same structure.

Conditions

Health Behavior; Health-Related Behavior; Stress

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Stress intervention

One arm : all volunteers will receive a stress management intervention.

Group Type: EXPERIMENTAL

Stress

Intervention Type: BEHAVIORAL

The stress management intervention will consist of three individual sessions, each lasting one hour, with approximately 15 days between each session. The sessions will be scheduled as follow: week 5 and 6 (session 1), week 7 and 8 (session 2), week 9, 10, and 11 (session 3). During these sessions, subjective and objective indicators of stress will be recorded to assess the progress of each student.

Interventions

Stress

The stress management intervention will consist of three individual sessions, each lasting one hour, with approximately 15 days between each session. The sessions will be scheduled as follow: week 5 and 6 (session 1), week 7 and 8 (session 2), week 9, 10, and 11 (session 3). During these sessions, subjective and objective indicators of stress will be recorded to assess the progress of each student.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Being a 4th-year or a 5th-year medical student at the Faculty of Medicine Lyon East during the academic year 2023-2024.
• Having read the information note.
• Having signed the written consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Research on Healthcare Performance Lab U1290

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sophie Schlatter, Dr.

Role: PRINCIPAL_INVESTIGATOR

RESHAPE U1290 INSERM UCBL-LYON 1 Rockfeller, Lyon France.

Locations

RESHAPE

Lyon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Sophie Schlatter, Dr.

Role: CONTACT

sophie.schlatter@univ-lyon1.fr

07 68 21 05 51 ext. 33

Facility Contacts

Sophie Schlatter, Dr.

Role: primary

sophie.schlatter@univ-lyon1.fr

07 68 21 05 51 ext. 33

Angèle Métais, Dr.

Role: backup

angele.metais@univ-lyon1.fr

06 77 39 89 66 ext. 33

References

Metais A, Omarjee M, Valero B, Gleich A, Mekki A, Henry A, Duclos A, Lilot M, Rode G, Schlatter S. Determining the influence of an intervention of stress management on medical students' levels of psychophysiological stress: the protocol of the PROMESS-Stress clinical trial. BMC Med Educ. 2025 Feb 11;25(1):225. doi: 10.1186/s12909-024-06344-8.

Reference Type: DERIVED

PMID: 39934759 (View on PubMed)

Other Identifiers

PROMESS - STRESS

Identifier Type: -

Identifier Source: org_study_id