NCT01061255

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2009

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 9, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 3, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2010

Completed
Last Updated

September 17, 2021

Status Verified

September 1, 2021

Enrollment Period

5 months

First QC Date

February 2, 2010

Last Update Submit

September 13, 2021

Conditions

Keywords

StressCortisolClinical reasoningAmbulatory settingMedical studentsYear 6 medical students

Outcome Measures

Primary Outcomes (1)

  • Increase in salivary cortisol and in Spielberger score

    one hour

Secondary Outcomes (1)

  • Difference in the cognitive appraisal (challenge or threat)

    one hour

Interventions

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.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Year 6 medical students who attend a one-month full-time course in an Internal Medicine Department

You may not qualify if:

  • Student who repeats his year 6 of medicine
  • Student treated with corticoids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantes University Hospital

Nantes, France

Location

Study Officials

  • Pierre POTTIER, Dr

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2010

First Posted

February 3, 2010

Study Start

November 9, 2009

Primary Completion

April 12, 2010

Study Completion

April 12, 2010

Last Updated

September 17, 2021

Record last verified: 2021-09

Locations