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临床试验/NCT05380076
NCT05380076已完成不适用

Effects of Mindfulness, Mobilization of Inner Resources, or Cardiac Biofeedback on Psychophysiological Anticipatory Stress Before OSCE of Medical Students

Claude Bernard University1 个研究点 分布在 1 个国家目标入组 490 人开始时间: 2022年5月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
490
试验地点
1
主要终点
Differences of physiological stress

研究概览

简要总结

Stress generated during the curriculum might have deleterious effects on the wellbeing and the health of medical students. Objective and Structured Clinical Examinations (OSCEs) will be incorporated soon in the certification process as a final national undergraduate ranking examination. This exam will be an additional major stressor for medical students.

Stress coping strategies could be implemented to help them better prepare for this examination. The aim of this study was to compare the efficiency on stress reduction of three different 6-minutes coping interventions in medical student, few minutes prior to the OSCE.

详细描述

This randomized, controlled and monocentric study will be conducted during the OSCE tests contributing towards the final exam grades for 4th year medicine students at the Claude Bernard Lyon 1 university.All the students will receive information for the study and sign consent before being randomized into four interventions groups. All the interventions will last six minutes long.

The randomisation groups are:

  • Mindfulness through watching/listening video tape
  • Mobilization of inner resources through watching/listening video tape
  • Cardiac biofeedback guided standardized timing for respiratory rate and with immediate feedback on cardiac variability score
  • Unemotional video tape as controlled group

Psychological stress will be measured using short questionnaires and self-rated Visual Analogue Scale (from 0 to 100mm) regarding perceived stress, answered by students before and after intervention. For measuring physiological stress, all the student will be equipped with emWAve® devices that allows us to record heart rate variability during the time of intervention. Students will also answer a questionnaire of personality.

Main objective is to show that interventions are better than control to reduce stress level before OSCE.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Interventions are standardized video tape. Information collected through standardized informatic questionnaires for blinded investigators.

入排标准

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

入选标准

  • Adult person
  • Registered as medical student at the university
  • Participating at OSCE examination
  • Have signed an informed consent form.

排除标准

  • 未提供

结局指标

主要结局

Differences of physiological stress

时间窗: During the 6min long intervention

Heart rate variability collected by an ear pulse sensor (emWave® device)

次要结局

  • Characterisation of intervention on Psychological stress consequences(measured two times: just 1 minute before and after the intervention)
  • Characterisation of the influence of the intervention on self-confidence(measured two times: just 30 seconds before and after the intervention)
  • Characterisation of the influence of the intervention on Psychological stress(measured two times: just 30 seconds before and after the intervention)
  • Characterisation of the influence of the intervention on level of inner resources(measured two times: just 30 seconds before and after the intervention)
  • Determining influence of personality traits on the efficiency on the intervention(just 5 minutes after the intervention)
  • Feelings about the intervention(just 2 minutes after the intervention)

研究者

发起方
Claude Bernard University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lilot Marc

Principal investigator

Claude Bernard University

研究点 (1)

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