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

6 november 2022 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

450

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Frankrijk
      • Lyon, Frankrijk, 69003
        • Marc lilot

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Biofeedback
Relaxing breathing exercise coupled with biofeedback before the circuit, no intervention after
Ander: Biofeedback

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.

Andere namen:
  • Relaxing breathing exercise coupled with biofeedback before the circuit, no intervention after
Experimenteel: Meditation
Meditative stimulation audio tape before the circuit, no intervention after
Ander: Meditation

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.

Andere namen:
  • Meditative stimulation audio tape before the circuit, no intervention after
Experimenteel: Control and biofeedback post OSCE
Standardised video before the circuit, Relaxing breathing exercise coupled with biofeedback after the OSCE
Ander: Control and biofeedback post 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

Andere namen:
  • Standardised video before the circuit, relaxing breathing exercise coupled with biofeedback after
Sham-vergelijker: Control and control post OSCE
Standardised video before the circuit, no intervention after
Ander: Control and control post 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 of free activity where the participants will not be given any instruction.

Andere namen:
  • Standardised video before the circuit, no intervention after

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Differences in Performance
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Differences of Physiological stress
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Just after second intervention at the end of the OSCE
Personality traits (Big-5)
Just after second intervention at the end of the OSCE

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Claude Bernard University

Onderzoekers

  • Studie stoel: Gilles Rode, M.D., Ph.D., Claude Bernard University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

7 december 2021

Primaire voltooiing (Werkelijk)

9 december 2021

Studie voltooiing (Werkelijk)

10 juni 2022

Studieregistratiedata

Eerst ingediend

4 november 2021

Eerst ingediend dat voldeed aan de QC-criteria

15 november 2021

Eerst geplaatst (Werkelijk)

29 november 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

8 november 2022

Laatste update ingediend die voldeed aan QC-criteria

6 november 2022

Laatst geverifieerd

1 november 2022

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ECOSTRESS

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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