Determining the influence of an intervention of stress management on medical students' levels of psychophysiological stress: the protocol of the PROMESS-Stress clinical trial.

Background: Medical students face highly competitive stressful situations throughout their curriculum, which can lead to elevated stress levels and a major decline in quality of life, well-being, learning abilities, and health. It is crucial to assist medical students in coping with these stressful situations during their curriculum.

Methods: The PROMESS-Stress clinical trial aims to support future healthcare professionals by enhancing their abilities to manage stressful situations. The support will be provided through a 3-session stress management program. Each session will include an individual meeting between a PROMESS-Stress expert and a medical student. To reduce stress levels and enhance coping mechanisms, these sessions will focus on establishing personalized advice and goals. The present protocol is designed to assess the influence of this program on forty-five undergraduate medical students (4th and 5th-year) of the Lyon-Est Faculty of Medicine (Claude Bernard University Lyon 1, France). Assessments of psychological and physiological stress variables will be conducted before and during the intervention. At the end of the 3rd session the student's levels of satisfaction will be assessed. The primary outcome will be changes in scores on the Perceived Stress Scale (PSS), while secondary outcomes will provide a detailed characterization of the intervention's effects on stress coping behaviors, psychological and physiological stress variables. Exploratory outcomes will provide information regarding the student's level of satisfaction and will determine the moderators of the program's efficacy. Data will be analyzed according to the intention-to-treat principle and presented in accordance with the CONSORT Guidelines. Ethical approval has been obtained by the Institutional Review Board (IRB: 2023-07-04-02) and all the procedures will be performed in adherence to the Helsinki declaration. Results from this study will be presented at scientific conferences and in peer-reviewed scientific journals.

Discussion: Results will provide valuable insights into the program's efficacy in reducing stress and improving coping abilities. If its efficacy is proven, PROMESS-Stress could become an integral and sustainable part of medical education, fostering a healthier and more resilient future for healthcare professionals. This manuscript follows the SPIRIT guidelines (Additional files 1 & 6).

Trial Registration: ClinicalTrials.gov: NCT06295133; retrospectively registered.