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

6. november 2022 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

450

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Frankrike
      • Lyon, Frankrike, 69003
        • Marc lilot

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Biofeedback
Relaxing breathing exercise coupled with biofeedback before the circuit, no intervention after
Annen: 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 navn:
  • Relaxing breathing exercise coupled with biofeedback before the circuit, no intervention after
Eksperimentell: Meditation
Meditative stimulation audio tape before the circuit, no intervention after
Annen: 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 navn:
  • Meditative stimulation audio tape before the circuit, no intervention after
Eksperimentell: Control and biofeedback post OSCE
Standardised video before the circuit, Relaxing breathing exercise coupled with biofeedback after the OSCE
Annen: 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 navn:
  • 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
Annen: 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 navn:
  • Standardised video before the circuit, no intervention after

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Claude Bernard University

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

7. desember 2021

Primær fullføring (Faktiske)

9. desember 2021

Studiet fullført (Faktiske)

10. juni 2022

Datoer for studieregistrering

Først innsendt

4. november 2021

Først innsendt som oppfylte QC-kriteriene

15. november 2021

Først lagt ut (Faktiske)

29. november 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. november 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. november 2022

Sist bekreftet

1. november 2022

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ECOSTRESS

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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