Effects of Relaxing Breathing With Biofeedback or Meditative Stimulation on Performances During OSCE of Medical Students (ECOSTRESS)
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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Lyon, Francia, 69003
- Marc lilot
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Biofeedback
Relaxing breathing exercise coupled with biofeedback before the circuit, no intervention after
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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.
Otros nombres:
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Experimental: Meditation
Meditative stimulation audio tape before the circuit, no intervention after
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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.
Otros nombres:
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Experimental: Control and biofeedback post OSCE
Standardised video before the circuit, Relaxing breathing exercise coupled with biofeedback after the OSCE
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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
Otros nombres:
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Comparador falso: Control and control post OSCE
Standardised video before the circuit, no intervention after
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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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Differences in Performance
Periodo de tiempo: During the first 2 hours of the inclusion
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The performance is student grade at the exam, as determined by university evaluator
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During the first 2 hours of the inclusion
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Differences of Physiological stress
Periodo de tiempo: During the first 2 hours of the inclusion
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Heart rate variation collected by emWave® devices
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During the first 2 hours of the inclusion
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Differences of Psychological stress
Periodo de tiempo: Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention
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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
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Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention
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Difference of Resourcefulness
Periodo de tiempo: Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention
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Numerical VAS on resourcefulness needeed an available perceived from zero to 100: maximum
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Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention
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Characterisation of stress
Periodo de tiempo: Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention
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Numerical VAS on characterisation of stress perceived from negative to positive
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Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention
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Differences of Self confidence
Periodo de tiempo: Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention
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Numerical VAS on self confidence perceived from zero to 100: maximum
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Four times : before first intervention, before OSCE circuit, just after OSCE circuit, just after second intervention
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Differences of Psychological stress consequences
Periodo de tiempo: Three times : before first intervention, before OSCE circuit, just after second intervention
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Activation-Deactivation Adjective Check List: for the four subscales: Energy, Tiredness, Tension , and Calmness
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Three times : before first intervention, before OSCE circuit, just after second intervention
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Differences of Ruminations
Periodo de tiempo: Just after second intervention at the end of the OSCE
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Brief rumination scale questionnaire
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Just after second intervention at the end of the OSCE
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Individual psychological characteristics
Periodo de tiempo: Just after second intervention at the end of the OSCE
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Personality traits (Big-5)
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Just after second intervention at the end of the OSCE
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Gilles Rode, M.D., Ph.D., Claude Bernard University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ECOSTRESS
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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