protocolSection identificationModule nctId: NCT06295133, orgStudyIdInfo id: PROMESS - STRESS, briefTitle: Preventive Remediation of Stress for Optimal MEdical StudentS, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-11, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Research on Healthcare Performance Lab U1290, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Health Behavior, conditions: Health-Related Behavior, conditions: Stress, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: All volunteers will receive a stress management intervention., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Stress, outcomesModule primaryOutcomes measure: Perceived level of stress : Evolution of the score obtained at the Perceived Stress Scale (PSS)., secondaryOutcomes measure: Scale of Holmes and Rahe : score obtained at the Holmes and Rahe Questionnaire Inventory., secondaryOutcomes measure: Big-5 : scores obtained at the Big-5 questionnaire., secondaryOutcomes measure: Coping strategies : scores obtained at the Brief Cope Inventory (BCI)., secondaryOutcomes measure: Perceived level of stress : score obtained at the Perceived Stress Scale, secondaryOutcomes measure: Heart rate variability (HRV) marker: cardiac coherence score during the pre-intervention., secondaryOutcomes measure: Heart rate variability (HRV) marker: SDNN during the pre-intervention., secondaryOutcomes measure: Heart rate variability (HRV) marker: RMSSD during the pre-intervention., secondaryOutcomes measure: Heart rate variability (HRV) marker: Low frequency / High frequency ratio (LF/HF) during the pre-intervention., secondaryOutcomes measure: Heart rate variability (HRV) marker: pnn50% during the pre-intervention., secondaryOutcomes measure: Coping strategies : Evolution in scores obtained at the Brief Cope Inventory (BCI)., secondaryOutcomes measure: Heart rate variability (HRV) marker: Evolution in cardiac coherence score during the intervention., secondaryOutcomes measure: Heart rate variability (HRV) marker: Evolution in SDNN score during the intervention., secondaryOutcomes measure: Heart rate variability (HRV) marker: Evolution in RMSSD score during the intervention., secondaryOutcomes measure: Heart rate variability (HRV) marker: Evolution in LF/HF ratio during the intervention., secondaryOutcomes measure: Heart rate variability (HRV) marker: Evolution in pnn50% score during the intervention., secondaryOutcomes measure: VAS - stressors quantity - Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived quantity of stressors, secondaryOutcomes measure: VAS - stress quantity - Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of stress., secondaryOutcomes measure: VAS - stress quality: Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the emotional valence associated with the stress level., secondaryOutcomes measure: VAS - stress coping: Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the management of stressful situations., secondaryOutcomes measure: Advices given by the expert. Score obtained on a Likert scale ranging from 1 to 5 characterizing the nature of the advices given by the expert., secondaryOutcomes measure: Likert - expert estimation of student's achievements. Score obtained on a Likert scale ranging from 1 to 3 accessing if the expert estimates that the student has achieve the goals previously set., secondaryOutcomes measure: Likert - expert satisfaction. Scores obtained on a Likert scale ranging from 1 to 5 accessing the expert's satisfaction of his/her intervention., secondaryOutcomes measure: Likert - expert level of comfort. Score assessing the expert comfort levels in participant relationships on a likert scale ranging from 1 to 5., secondaryOutcomes measure: Likert - expert estimation of the overall student's achievements. Score obtained on a Likert scale ranging from 1 to 5 accessing the expert's level of satisfaction on the student's progress., secondaryOutcomes measure: Composite score - Student's satisfaction. Score ranging from 0 to 100 accessing the student's level of satisfaction of the all intervention., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: RESHAPE, status: RECRUITING, city: Lyon, zip: 69008, country: France, contacts name: Sophie Schlatter, Dr., role: CONTACT, phone: 07 68 21 05 51, phoneExt: 33, email: sophie.schlatter@univ-lyon1.fr, contacts name: Angèle Métais, Dr., role: CONTACT, phone: 06 77 39 89 66, phoneExt: 33, email: angele.metais@univ-lyon1.fr, geoPoint lat: 45.74848, lon: 4.84669, hasResults: False