Effects of Relaxing Breathing With Biofeedback or Meditative Stimulation on Performances During OSCE of Medical Students (ECOSTRESS)
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
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.
調査の概要
状態
詳細な説明
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
At the end of the examination circuit, all the students will undergo short questionnaires regarding stress, participants will get equipped with emWAve ® devices again and participants will get the second intervention depending on the randomisation group.
Main objective is to show that relaxing breathing exercise coupled with biofeedback or meditative stimulation is better than an standardised video on performance during OSCE.
The main outcome is student grade at the exam, as determined by university evaluator who is blind to the intervention and with no links to the study.
Secondary objectives are to compare the effects of the interventions on measured physiological stress, psychological stress, and negative rumination.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Lyon、フランス、69003
- Marc lilot
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Adult person
- Registered as medical student at the university
- Participating at OSCE examination
- Have signed an informed consent form.
Exclusion Criteria:
- None
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Biofeedback
Relaxing breathing exercise coupled with biofeedback before the circuit, no intervention after
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6 minutes of relaxing breathing exercise coupled with hert rate variability biofeedback guided on eMWave Pro software on a computer just before entering the examination circuit. After the circuit, 6 minutes of free activity where the participants will not be given any instruction.
他の名前：
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実験的：Meditation
Meditative stimulation audio tape before the circuit, no intervention after
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6 minutes of listening an audio tape made for the study that inspire mindfulness like meditation associated with psychological stimulation (positive encouragement) just before entering the examination circuit. After the circuit, 6 minutes of free activity where the participants will not be given any instructions.
他の名前：
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実験的：Control and biofeedback post OSCE
Standardised video before the circuit, Relaxing breathing exercise coupled with biofeedback after the OSCE
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6 minutes of standardised neutral video on general topics that generates no modification of affects just before entering the examination circuit. After the circuit, 6 minutes of relaxing breathing exercise coupled with hert rate variability biofeedback guided on eMWave Pro software on a computer
他の名前：
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偽コンパレータ：Control and control post OSCE
Standardised video before the circuit, no intervention after
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6 minutes of standardised neutral video on general topics that generates no modification of affects just before entering the examination circuit. After the circuit, 6 minutes of of free activity where the participants will not be given any instruction.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Differences in Performance
時間枠：During the first 2 hours of the inclusion
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The performance is student grade at the exam, as determined by university evaluator
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During the first 2 hours of the inclusion
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Differences of Physiological stress
時間枠：During the first 2 hours of the inclusion
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Heart rate variation collected by emWave® devices
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During the first 2 hours of the inclusion
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Differences of Psychological stress
時間枠：Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention
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Numerical Visual analog scales (VAS) on perceived stress from zero to 100: maximum Numerical VAS on resourcefulness nedeed an avalaible perceived from zero to maximum
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Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention
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Difference of Resourcefulness
時間枠：Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention
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Numerical VAS on resourcefulness needeed an available perceived from zero to 100: maximum
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Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention
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Characterisation of stress
時間枠：Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention
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Numerical VAS on characterisation of stress perceived from negative to positive
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Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention
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Differences of Self confidence
時間枠：Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention
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Numerical VAS on self confidence perceived from zero to 100: maximum
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Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention
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Differences of Psychological stress consequences
時間枠：Three times : before first intervention, before OSCE circuit, just after second intervention
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Activation-Deactivation Adjective Check List: for the four subscales: Energy, Tiredness, Tension , and Calmness
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Three times : before first intervention, before OSCE circuit, just after second intervention
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Differences of Ruminations
時間枠：Just after second intervention at the end of the OSCE
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Brief rumination scale questionnaire
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Just after second intervention at the end of the OSCE
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Individual psychological characteristics
時間枠：Just after second intervention at the end of the OSCE
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Personality traits (Big-5)
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Just after second intervention at the end of the OSCE
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協力者と研究者
捜査官
- スタディチェア：Gilles Rode, M.D., Ph.D.、Claude Bernard University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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