Clinical trial NCT06295133: Preventive Remediation of Stress for Optimal MEdical StudentS
Official title: Determining the Influence of a Stress Management Intervention on Medical Students Levels of Psychophysiological Stress and Satisfaction.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Health Behavior
Health-Related Behavior
Stress
Keywords: Health
Student
Curriculum
Behaviour
Medical
Stress
Lead sponsor: Research on Healthcare Performance Lab U1290
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All volunteers will receive a stress management intervention.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Exclusion Criteria:

* No exclusion criteria will be applied.

Primary outcomes:
measure: Perceived level of stress : Evolution of the score obtained at the Perceived Stress Scale (PSS).
timeFrame: From week 5 to week 11.
Secondary outcomes:
measure: Scale of Holmes and Rahe : score obtained at the Holmes and Rahe Questionnaire Inventory.
timeFrame: Week 1 (Pre-intervention).
measure: Big-5 : scores obtained at the Big-5 questionnaire.
timeFrame: Week 1 (Pre-intervention).
measure: Coping strategies : scores obtained at the Brief Cope Inventory (BCI).
timeFrame: Week 1 (Pre-intervention).
measure: Perceived level of stress : score obtained at the Perceived Stress Scale
timeFrame: Week 1 (Pre-intervention).
measure: Heart rate variability (HRV) marker: cardiac coherence score during the pre-intervention.
timeFrame: Week 1 (Pre-intervention).
measure: Heart rate variability (HRV) marker: SDNN during the pre-intervention.
timeFrame: Week 1 (Pre-intervention).
measure: Heart rate variability (HRV) marker: RMSSD during the pre-intervention.
timeFrame: Week 1 (Pre-intervention).
measure: Heart rate variability (HRV) marker: Low frequency / High frequency ratio (LF/HF) during the pre-intervention.
timeFrame: Week 1 (Pre-intervention).
measure: Heart rate variability (HRV) marker: pnn50% during the pre-intervention.
timeFrame: Week 1 (Pre-intervention).
measure: Coping strategies : Evolution in scores obtained at the Brief Cope Inventory (BCI).
timeFrame: From week 5 to week 11.
measure: Heart rate variability (HRV) marker: Evolution in cardiac coherence score during the intervention.
timeFrame: From week 5 to week 11.
measure: Heart rate variability (HRV) marker: Evolution in SDNN score during the intervention.
timeFrame: From week 5 to week 11.
measure: Heart rate variability (HRV) marker: Evolution in RMSSD score during the intervention.
timeFrame: From week 5 to week 11.
measure: Heart rate variability (HRV) marker: Evolution in LF/HF ratio during the intervention.
timeFrame: From week 5 to week 25.
measure: Heart rate variability (HRV) marker: Evolution in pnn50% score during the intervention.
timeFrame: From week 5 to week 11.
measure: VAS - stressors quantity - Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived quantity of stressors
timeFrame: From week 5 to week 11.
measure: VAS - stress quantity - Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of stress.
timeFrame: From week 5 to week 11.
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.
timeFrame: From week 5 to week 11.
measure: VAS - stress coping: Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the management of stressful situations.
timeFrame: From week 5 to week 11.
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.
timeFrame: From week 5 to week 11.
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.
timeFrame: From week 5 to week 11.
measure: Likert - expert satisfaction. Scores obtained on a Likert scale ranging from 1 to 5 accessing the expert's satisfaction of his/her intervention.
timeFrame: From week 5 to week 11.
measure: Likert - expert level of comfort. Score assessing the expert comfort levels in participant relationships on a likert scale ranging from 1 to 5.
timeFrame: From week 5 to week 11.
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.
timeFrame: Week 9-10-11
measure: Composite score - Student's satisfaction. Score ranging from 0 to 100 accessing the student's level of satisfaction of the all intervention.
timeFrame: Week 9-10-11
Other outcomes:
Locations:
city: Lyon
country: France
facility: RESHAPE
Study officials:
affiliation: RESHAPE U1290 INSERM UCBL-LYON 1 Rockfeller, Lyon France.
name: Sophie Schlatter, Dr.
role: PRINCIPAL_INVESTIGATOR
References: