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临床试验/NCT06295133
NCT06295133Unknown不适用

Determining the Influence of a Stress Management Intervention on Medical Students Levels of Psychophysiological Stress and Satisfaction.

Research on Healthcare Performance Lab U12902 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2023年11月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
45
试验地点
2
主要终点
Perceived level of stress : Evolution of the score obtained at the Perceived Stress Scale (PSS).

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • No exclusion criteria will be applied.

研究组 & 干预措施

Stress intervention

Experimental

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

干预措施: Stress (Behavioral)

结局指标

主要结局

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

时间窗: From week 5 to week 11.

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).

次要结局

  • Big-5 : scores obtained at the Big-5 questionnaire.(Week 1 (Pre-intervention).)
  • Scale of Holmes and Rahe : score obtained at the Holmes and Rahe Questionnaire Inventory.(Week 1 (Pre-intervention).)
  • Coping strategies : scores obtained at the Brief Cope Inventory (BCI).(Week 1 (Pre-intervention).)
  • Heart rate variability (HRV) marker: SDNN during the pre-intervention.(Week 1 (Pre-intervention).)
  • Heart rate variability (HRV) marker: Evolution in LF/HF ratio during the intervention.(From week 5 to week 25.)
  • Heart rate variability (HRV) marker: cardiac coherence score during the pre-intervention.(Week 1 (Pre-intervention).)
  • Coping strategies : Evolution in scores obtained at the Brief Cope Inventory (BCI).(From week 5 to week 11.)
  • Heart rate variability (HRV) marker: Evolution in pnn50% score during the intervention.(From week 5 to week 11.)
  • 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.(From week 5 to week 11.)
  • Composite score - Student's satisfaction. Score ranging from 0 to 100 accessing the student's level of satisfaction of the all intervention.(Week 9-10-11)
  • Perceived level of stress : score obtained at the Perceived Stress Scale(Week 1 (Pre-intervention).)
  • Heart rate variability (HRV) marker: RMSSD during the pre-intervention.(Week 1 (Pre-intervention).)
  • Heart rate variability (HRV) marker: pnn50% during the pre-intervention.(Week 1 (Pre-intervention).)
  • VAS - stressors quantity - Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived quantity of stressors(From week 5 to week 11.)
  • VAS - stress quantity - Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of stress.(From week 5 to week 11.)
  • Likert - expert level of comfort. Score assessing the expert comfort levels in participant relationships on a likert scale ranging from 1 to 5.(From week 5 to week 11.)
  • VAS - stress coping: Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the management of stressful situations.(From week 5 to week 11.)
  • Heart rate variability (HRV) marker: Low frequency / High frequency ratio (LF/HF) during the pre-intervention.(Week 1 (Pre-intervention).)
  • Heart rate variability (HRV) marker: Evolution in cardiac coherence score during the intervention.(From week 5 to week 11.)
  • Heart rate variability (HRV) marker: Evolution in SDNN score during the intervention.(From week 5 to week 11.)
  • Heart rate variability (HRV) marker: Evolution in RMSSD score during the intervention.(From week 5 to week 11.)
  • 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.(From week 5 to week 11.)
  • 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.(From week 5 to week 11.)
  • Likert - expert satisfaction. Scores obtained on a Likert scale ranging from 1 to 5 accessing the expert's satisfaction of his/her intervention.(From week 5 to week 11.)
  • 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.(Week 9-10-11)

研究者

发起方
Research on Healthcare Performance Lab U1290
申办方类型
Other
责任方
Sponsor

研究点 (2)

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