- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01061255
Stress and Clinical Reasoning in Medical Students
Physiological and Psychological Responses to Stress in Year 6 Medical Students Faced to Ambulatory Symptomatic Patients
Solving a problem in ambulatory setting may contain peripheral stress due to socio-evaluative stressors (patient's expectations about explanations) and task contingent stress due to time pressure, the necessity to take into account patient's mood, to deal with uncertainty of their own data collection and with complex clinical situations. In France, excepted for family medicine, undergraduate medical students and residents are currently not trained to perform consultations and are never exposed to ambulatory patients during training. The investigators postulate that this lack of practice may generate a significant state of stress during the first consultations and consequently modify or even impair clinical reasoning.
The primary objective of this study is to compare subjective and physiological levels of acute stress in ambulatory versus hospitalization setting in medical students confronted to a real patient with a diagnostic problem.
Measures: The French version of the Anxiety Spielberger test is administered just before and after each problem solving session.
Cortisol salivary samples are taken before and after each problem solving session. Salivary cortisol levels have been shown to be correlated to stressful situations and some personality traits but with some difference according to gender.
Cognitive appraisal (threat/challenge) is assessed before and after the tasks by the ratio of primary appraisal to secondary appraisal according to Tomaka et al.
Study Overview
Detailed Description
Participants and Method:
Year 6 medical students who attend a one-month full-time course in an Internal Medicine Department are eligible.
Since no consultations in the ambulatory setting are currently structured for medical students, the following adjustments have been done within the internal medicine consultation department, with the approval of the department director:
- the consultation duration has been increased (1 hour instead of 30 minutes)
- during the first 30 minutes, consultation is performed by the participant
- during the following 30 minutes, the patient is examined by his/her own physician.
- The consent of the patient has been obtained by phone (prior to the consultation).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Nantes, France
- Nantes University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Year 6 medical students who attend a one-month full-time course in an Internal Medicine Department
Exclusion Criteria:
- Student who repeats his year 6 of medicine
- Student treated with corticoids
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Increase in salivary cortisol and in Spielberger score
Time Frame: one hour
|
one hour
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Difference in the cognitive appraisal (challenge or threat)
Time Frame: one hour
|
one hour
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pierre POTTIER, Dr, Nantes University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BRD/09/08-M
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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