NCT05390879

Brief Summary

Stress and rumination are linked with the development of many mental disorders. The ECOSTRESS study has shown that poor OSCE performance has a positive effect on the occurence of state-rumination among 4th year medicine students in the context of mock exams. The goal of IMSR study is to assess the effectiveness of a post-OSCE meditation intervention to decrease psychological stress and rumination.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

May 17, 2022

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2022

Completed
Last Updated

November 8, 2022

Status Verified

November 1, 2022

Enrollment Period

3 days

First QC Date

May 12, 2022

Last Update Submit

November 6, 2022

Conditions

Stress, PsychologicalStress, PhysiologicalRuminationExam Stress

Keywords

StressPerformance and ruminationsCopingRuminationMeditationExamhealth-student

Outcome Measures

Primary Outcomes (1)

  • Change in rumination

    BSRI - Brief State Rumination Inventory, assessing state-rumination

    Between before and after the intervention measured just 2 minutes before and 2 minutes after interventions (during one hour after inclusion)

Secondary Outcomes (7)

  • Physiological stress

    During the 6 minutes long intervention (during one hour after inclusion)

  • Change in psychological stress level

    Between before and after the intervention measured just 2 minutes before and 2 minutes after interventions (during one hour after inclusion)

  • Change in characterisation of stress

    Between before and after the intervention measured just 2 minutes before and 2 minutes after interventions (during one hour after inclusion)

  • Change in self confidence

    Between before and after the intervention measured just 2 minutes before and 2 minutes after interventions (during one hour after inclusion)

  • Rumination

    One time : After intervention (during one hour after inclusion)

  • +2 more secondary outcomes

Study Arms (2)

Meditation Post-OSCE

EXPERIMENTAL

One half of the students will watch a 6 minutes auto-guided video of meditation, just after the OSCE.

Other: Meditation

Control

SHAM COMPARATOR

One half of the students will watch a 6 minutes control video, just after the OSCE

Other: Control

Interventions

MeditationOTHER

After the circuit, a 6 minutes long meditation auto-guided video.

Meditation Post-OSCE
ControlOTHER

After the circuit, a 6 minutes long emotionally neutral video.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marc lilot

Lyon, 69003, France

Location

MeSH Terms

Conditions

Stress, PsychologicalRumination Syndrome

Interventions

Meditation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorGastrointestinal DiseasesDigestive System DiseasesFeeding and Eating DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesRelaxation TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Gilles Rode, MD, PhD

    Claude Bernard University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Assessors are blind concerning the principal outcome (ruminations and post-OSCE meditation groups, via standardized informatic questionnaires) Performance is evaluated by assessors who are blind to the intervention
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 2 parallels groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 12, 2022

First Posted

May 25, 2022

Study Start

May 17, 2022

Primary Completion

May 20, 2022

Study Completion

June 10, 2022

Last Updated

November 8, 2022

Record last verified: 2022-11

Locations

FR(1)