Effects of Mindfulness, Mobilization of Resources, or Biofeedback on Stress Before OSCE

NCT05380076 | Completed

• 1 other identifier: OsceStress
• Study Type: interventional
• Target: 490
• Locations: 1 country
• Sites: 1

Brief Summary

Stress generated during the curriculum might have deleterious effects on the wellbeing and the health of medical students. Objective and Structured Clinical Examinations (OSCEs) will be incorporated soon in the certification process as a final national undergraduate ranking examination. This exam will be an additional major stressor for medical students. Stress coping strategies could be implemented to help them better prepare for this examination. The aim of this study was to compare the efficiency on stress reduction of three different 6-minutes coping interventions in medical student, few minutes prior to the OSCE.

Conditions

Exam Stress; Stress, Psychological; Stress, Physiological

Outcome Measures

Primary Outcomes (1)

• Differences of physiological stress

  Heart rate variability collected by an ear pulse sensor (emWave® device)

  During the 6min long intervention

Secondary Outcomes (6)

• Characterisation of the influence of the intervention on Psychological stress

  measured two times: just 30 seconds before and after the intervention

• Characterisation of the influence of the intervention on level of inner resources

  measured two times: just 30 seconds before and after the intervention

• Characterisation of the influence of the intervention on self-confidence

  measured two times: just 30 seconds before and after the intervention

• Characterisation of intervention on Psychological stress consequences

  measured two times: just 1 minute before and after the intervention

• Feelings about the intervention

  just 2 minutes after the intervention

Study Arms (4)

Mindfulness

EXPERIMENTAL

Mindfulness meditation video before the circuit

Other: Mindfulness meditation

Mobilization of inner resources

EXPERIMENTAL

Standardised video before the circuit

Other: Mobilization of inner resources

Biofeedback

EXPERIMENTAL

Cardiac biofeedback before the circuit

Other: Biofeedback

Control

SHAM COMPARATOR

Standardised video before the circuit

Other: Mindfulness meditation; Other: Mobilization of inner resources; Other: Biofeedback

Interventions

Mindfulness meditation OTHER

6 minutes of watching a video tape made for the study that inspire mindfulness like meditation just before entering the examination circuit.

Control; Mindfulness

Mobilization of inner resources OTHER

6 minutes of watching a video tape made for the study that provide psychological stimulation just before entering the examination circuit

Control; Mobilization of inner resources

Biofeedback OTHER

6 minutes of relaxing breathing exercise coupled with heart rate variability biofeedback guided on eMWave Pro software on a computer just before entering the examination circuit.

Biofeedback; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Claude Bernard University: lead

Study Sites (1)

Claude Bernard University

Lyon, France

Location

MeSH Terms

Conditions

Stress, Psychological

Interventions

Mindfulness; Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Mind-Body Therapies; Complementary Therapies; Therapeutics; Feedback, Psychological

Study Officials

• Gilles Rode, PhD

  Claude Bernard University

  STUDY CHAIR

• Marc Lilot, PhD

  Claude Bernard University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Interventions are standardized video tape. Information collected through standardized informatic questionnaires for blinded investigators.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 4 parallel groups

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: May 18, 2022
• Study Start: May 17, 2022
• Primary Completion: June 30, 2022
• Study Completion: December 30, 2023
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)