Preventive Remediation of Stress for Optimal MEdical StudentS

NCT06295133 | Recruiting

• 1 other identifier: PROMESS - STRESS
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Behavior; Health-Related Behavior; Stress

Keywords

Health; Student; Curriculum; Behaviour; Medical; Stress

Outcome Measures

Primary Outcomes (1)

• Perceived level of stress : Evolution of the score obtained at the Perceived Stress Scale (PSS).

  The students level of stress will be assessed through the PSS questionnaire ranging from 0 (none) to 40 (extreme). One score is assessed and can be classified as low, moderate and elevated stress. The measure will be done every session, i.e. session 1 (week 5-6), session 2 (week 7-8) and session 3 (week 9,10,11).

  From week 5 to week 11.

Secondary Outcomes (25)

• Scale of Holmes and Rahe : score obtained at the Holmes and Rahe Questionnaire Inventory.

  Week 1 (Pre-intervention).

• Big-5 : scores obtained at the Big-5 questionnaire.

  Week 1 (Pre-intervention).

• Coping strategies : scores obtained at the Brief Cope Inventory (BCI).

  Week 1 (Pre-intervention).

• Perceived level of stress : score obtained at the Perceived Stress Scale

  Week 1 (Pre-intervention).

• Heart rate variability (HRV) marker: cardiac coherence score during the pre-intervention.

  Week 1 (Pre-intervention).

Study Arms (1)

Stress intervention

EXPERIMENTAL

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

Behavioral: Stress

Interventions

Stress 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.

Stress intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Research on Healthcare Performance Lab U1290: lead

Study Sites (1)

RESHAPE

Lyon, 69008, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 39934759 DERIVED

MeSH Terms

Conditions

Health Behavior; Behavior

Study Officials

• Sophie Schlatter, Dr.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie Schlatter, Dr.

CONTACT

07 68 21 05 51; sophie.schlatter@univ-lyon1.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All volunteers will receive a stress management intervention.

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 6, 2024
• Study Start: November 11, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-02

Locations

FR (1)