StressNCT01061255
Stress and Clinical Reasoning in Medical Students
A study testing Evaluation of the stress in people with Stress, run by Nantes University Hospital at 1 site in France.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Evaluation of the stress
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- 9 Nov 2009to 12 Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Year 6 medical students who attend a one-month full-time course in an Internal Medicine Department
Who cannot join
- Student who repeats his year 6 of medicine
- Student treated with corticoids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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).
- Conditions
- Stress
- Being tested
- Evaluation of the stress
- Keywords
- Stress, Cortisol, Clinical reasoning, Ambulatory setting, Medical students, Year 6 medical students
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the stressOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in salivary cortisol and in Spielberger score
Measured: one hour
Secondary outcomes (1)
Difference in the cognitive appraisal (challenge or threat)
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2010 (estimated)
- Study start9 Nov 2009
- Primary completion12 Apr 2010
- Study completion12 Apr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre POTTIER, Dr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01061255
- Sponsor's protocol ID
- BRD/09/08-M
- Status last verified
- Sep 2021
- First submitted
- 2 Feb 2010
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Pottier P, Dejoie T, Hardouin JB, Le Loupp AG, Planchon B, Bonnaud A, Leblanc VR. Effect of stress on clinical reasoning during simulated ambulatory consultations. Med Teach. 2013 Jun;35(6):472-80. doi: 10.3109/0142159X.2013.774336. Epub 2013 Mar 6.
PubMed 23464842
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological and Psychological Responses to Stress in Year 6 Medical Students Faced to Ambulatory Symptomatic Patients
- ClinicalTrials.gov ID
- NCT01061255
- Acronym / sponsor ID
- BRD/09/08-M
- Conditions
- Stress
- Keywords
- Stress, Cortisol, Clinical reasoning, Ambulatory setting, Medical students, Year 6 medical students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 9 Nov 2009 (actual)
- Primary completion
- 12 Apr 2010 (actual)
- Study completion
- 12 Apr 2010 (actual)
- First posted
- 3 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Year 6 medical students who attend a one-month full-time course in an Internal Medicine Department
Key exclusion criteria (2 listed)
- Student who repeats his year 6 of medicine
- Student treated with corticoids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of the stressMedical 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. | Other | – |
Primary outcome
Increase in salivary cortisol and in Spielberger score
Time frame: one hour
1 secondary outcome
Difference in the cognitive appraisal (challenge or threat)
Time frame: one hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Results publication: PubMed 23464842Pottier P, Dejoie T, Hardouin JB, Le Loupp AG, Planchon B, Bonnaud A, Leblanc VR. Effect of stress on clinical reasoning during simulated ambulatory consultations. Med Teach. 2013 Jun;35(6):472-80. doi: 10.3109/0142159X.2013.774336. Epub 2013 Mar 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre POTTIER, Dr principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of the stress in people with Stress, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in salivary cortisol and in Spielberger score (time frame: one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01061255, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.