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临床试验/NCT05136586
NCT05136586已完成不适用

Effects of Two Stress Management Procedures on Performances During Objective Structured Clinical Examination (OSCE) for Medical Students : Relaxing Breathing Combined With Biofeedback or Meditative Stimulation : ECOSTRESS Study

Claude Bernard University2 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2021年12月7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
450
试验地点
2
主要终点
Differences in Performance

研究概览

简要总结

Objective Structured Clinical Examination (OSCE) is a newly implemented evaluation standard for medical student and is a determinant part of the national competition they have to undergo.

Medical studies, especially during examen period, are significantly associated with risk of developping depressions or anxious trouble, wich led to lesser performance, impaired memorization and impaired workload capacities.

Relaxation breathing techniques coupled with heart rate variability (HRV) biofeedback and meditation are procedures used to reduce the stress level.

There is currently no study on the effect of stress management procedures on the performance during OSCE for medical student.

详细描述

This randomized, controlled, monocentric study will take place during mandatory rehearsal of Objective Structured Clinical Examination for third year medical student. For examination purpose, the students will be divided in four groups that will undergo identical exam in the same time in four parallels circuits.

Before entering the circuit, all the students will received information for the study and sign consent.

All the students will be equipped with emWAve® devices that allows us to collect heart rate variability as physiological stress marker during the time of the intervention. Participants will undergo short questionnaires regarding perceived stress.

Then the groups of students will be randomized in four interventions groups for receiving a combination of intervention before and/or after the examination circuit. All the interventions last six minutes long. The randomisation groups are :

  • Relaxing breathing exercise coupled with biofeedback before the circuit, no intervention after
  • Meditative stimulation audio tape before the circuit, no intervention after
  • Standardised video as controlled group before the circuit and a relaxing breathing exercise coupled with biofeedback after
  • Standardised video as controlled group before and not intervention after

研究设计

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

盲法说明

Performance is evaluated by assessors who are blind to the intervention

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 in Performance

时间窗: During the first 2 hours of the inclusion

The performance is student grade at the exam, as determined by university evaluator

次要结局

  • Differences of Physiological stress(During the first 2 hours of the inclusion)
  • Characterisation of stress(Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention)
  • Differences of Self confidence(Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention)
  • Differences of Psychological stress consequences(Three times : before first intervention, before OSCE circuit, just after second intervention)
  • Differences of Ruminations(Just after second intervention at the end of the OSCE)
  • Differences of Psychological stress(Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention)
  • Difference of Resourcefulness(Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention)
  • Individual psychological characteristics(Just after second intervention at the end of the OSCE)

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 (2)

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