We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Stress and Clinical Reasoning in Medical Students

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01061255
First Posted: February 3, 2010
Last Update Posted: July 23, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Nantes University Hospital
  Purpose

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.


Condition Intervention
Stress Other: Evaluation of the stress

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Physiological and Psychological Responses to Stress in Year 6 Medical Students Faced to Ambulatory Symptomatic Patients

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Increase in salivary cortisol and in Spielberger score [ Time Frame: one hour ]

Secondary Outcome Measures:
  • Difference in the cognitive appraisal (challenge or threat) [ Time Frame: one hour ]

Enrollment: 62
Study Start Date: November 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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.

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).
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01061255


Locations
France
Nantes University Hospital
Nantes, France
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Pierre POTTIER, Dr Nantes University Hospital
  More Information

Responsible Party: Anne Omnès, University Hospital of Nantes
ClinicalTrials.gov Identifier: NCT01061255     History of Changes
Other Study ID Numbers: 09/8-M
First Submitted: February 2, 2010
First Posted: February 3, 2010
Last Update Posted: July 23, 2010
Last Verified: July 2010

Keywords provided by Nantes University Hospital:
Stress
Cortisol
Clinical reasoning
Ambulatory setting
Medical students
Year 6 medical students