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

6. november 2022 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

450

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Lyon, Frankrig, 69003
        • Marc lilot

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Biofeedback
Relaxing breathing exercise coupled with biofeedback before the circuit, no intervention after
Andet: 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.

Andre navne:
  • Relaxing breathing exercise coupled with biofeedback before the circuit, no intervention after
Eksperimentel: Meditation
Meditative stimulation audio tape before the circuit, no intervention after
Andet: 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.

Andre navne:
  • Meditative stimulation audio tape before the circuit, no intervention after
Eksperimentel: Control and biofeedback post OSCE
Standardised video before the circuit, Relaxing breathing exercise coupled with biofeedback after the OSCE
Andet: 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

Andre navne:
  • Standardised video before the circuit, relaxing breathing exercise coupled with biofeedback after
Sham-komparator: Control and control post OSCE
Standardised video before the circuit, no intervention after
Andet: 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.

Andre navne:
  • Standardised video before the circuit, no intervention after

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Differences in Performance
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Differences of Physiological stress
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Just after second intervention at the end of the OSCE
Personality traits (Big-5)
Just after second intervention at the end of the OSCE

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Claude Bernard University

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

7. december 2021

Primær færdiggørelse (Faktiske)

9. december 2021

Studieafslutning (Faktiske)

10. juni 2022

Datoer for studieregistrering

Først indsendt

4. november 2021

Først indsendt, der opfyldte QC-kriterier

15. november 2021

Først opslået (Faktiske)

29. november 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. november 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. november 2022

Sidst verificeret

1. november 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ECOSTRESS

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