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

6 november 2022 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

450

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Frankrike
      • Lyon, Frankrike, 69003
        • Marc lilot

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Biofeedback
Relaxing breathing exercise coupled with biofeedback before the circuit, no intervention after
Övrig: 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.

Andra namn:
  • Relaxing breathing exercise coupled with biofeedback before the circuit, no intervention after
Experimentell: Meditation
Meditative stimulation audio tape before the circuit, no intervention after
Övrig: 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.

Andra namn:
  • Meditative stimulation audio tape before the circuit, no intervention after
Experimentell: Control and biofeedback post OSCE
Standardised video before the circuit, Relaxing breathing exercise coupled with biofeedback after the OSCE
Övrig: 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

Andra namn:
  • Standardised video before the circuit, relaxing breathing exercise coupled with biofeedback after
Sham Comparator: Control and control post OSCE
Standardised video before the circuit, no intervention after
Övrig: 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.

Andra namn:
  • Standardised video before the circuit, no intervention after

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Differences in Performance
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Differences of Physiological stress
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Just after second intervention at the end of the OSCE
Personality traits (Big-5)
Just after second intervention at the end of the OSCE

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Claude Bernard University

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

7 december 2021

Primärt slutförande (Faktisk)

9 december 2021

Avslutad studie (Faktisk)

10 juni 2022

Studieregistreringsdatum

Först inskickad

4 november 2021

Först inskickad som uppfyllde QC-kriterierna

15 november 2021

Första postat (Faktisk)

29 november 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

8 november 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 november 2022

Senast verifierad

1 november 2022

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • ECOSTRESS

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