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Effects of Relaxing Breathing With Biofeedback or Meditative Stimulation on Performances During OSCE of Medical Students (ECOSTRESS)

6 novembre 2022 mis à jour par: Lilot Marc, Claude Bernard University

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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

450

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

      • Lyon, France, 69003
        • Marc lilot

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Biofeedback
Relaxing breathing exercise coupled with biofeedback before the circuit, no intervention after

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.

Autres noms:
  • Relaxing breathing exercise coupled with biofeedback before the circuit, no intervention after
Expérimental: Meditation
Meditative stimulation audio tape before the circuit, no intervention after

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.

Autres noms:
  • Meditative stimulation audio tape before the circuit, no intervention after
Expérimental: Control and biofeedback post OSCE
Standardised video before the circuit, Relaxing breathing exercise coupled with biofeedback after the OSCE

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

Autres noms:
  • Standardised video before the circuit, relaxing breathing exercise coupled with biofeedback after
Comparateur factice: Control and control post OSCE
Standardised video before the circuit, no intervention after

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.

Autres noms:
  • Standardised video before the circuit, no intervention after

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Differences in Performance
Délai: During the first 2 hours of the inclusion
The performance is student grade at the exam, as determined by university evaluator
During the first 2 hours of the inclusion

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Differences of Physiological stress
Délai: During the first 2 hours of the inclusion
Heart rate variation collected by emWave® devices
During the first 2 hours of the inclusion
Differences of Psychological stress
Délai: Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention
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
Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention
Difference of Resourcefulness
Délai: Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention
Numerical VAS on resourcefulness needeed an available perceived from zero to 100: maximum
Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention
Characterisation of stress
Délai: Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention
Numerical VAS on characterisation of stress perceived from negative to positive
Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention
Differences of Self confidence
Délai: Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention
Numerical VAS on self confidence perceived from zero to 100: maximum
Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention
Differences of Psychological stress consequences
Délai: Three times : before first intervention, before OSCE circuit, just after second intervention
Activation-Deactivation Adjective Check List: for the four subscales: Energy, Tiredness, Tension , and Calmness
Three times : before first intervention, before OSCE circuit, just after second intervention
Differences of Ruminations
Délai: Just after second intervention at the end of the OSCE
Brief rumination scale questionnaire
Just after second intervention at the end of the OSCE
Individual psychological characteristics
Délai: Just after second intervention at the end of the OSCE
Personality traits (Big-5)
Just after second intervention at the end of the OSCE

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chaise d'étude: Gilles Rode, M.D., Ph.D., Claude Bernard University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

7 décembre 2021

Achèvement primaire (Réel)

9 décembre 2021

Achèvement de l'étude (Réel)

10 juin 2022

Dates d'inscription aux études

Première soumission

4 novembre 2021

Première soumission répondant aux critères de contrôle qualité

15 novembre 2021

Première publication (Réel)

29 novembre 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

8 novembre 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 novembre 2022

Dernière vérification

1 novembre 2022

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • ECOSTRESS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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