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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01061255
Other study ID # BRD/09/08-M
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 9, 2009
Est. completion date April 12, 2010

Study information

Verified date September 2021
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date April 12, 2010
Est. primary completion date April 12, 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Evaluation of the stress
Medical Students having to solve a medical problem in ambulatory setting (studied group) vs. in hospitalisation setting (control group). 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.

Locations

Country Name City State
France Nantes University Hospital Nantes

Sponsors (1)

Lead Sponsor Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Increase in salivary cortisol and in Spielberger score one hour
Secondary Difference in the cognitive appraisal (challenge or threat) one hour
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