Undergraduate Medical Students' Learning Process in Doctor-patient Relationship TrainingAPTHERANCT03559998
Learning Process of Fourth Year Medical Students During a Doctor-patient Relationship Training
An observational study of Undergraduate Medical Students' Learning Process in Doctor-patient Relationship Training, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This study aims to explore learning process for undergraduate students in this doctor-patient relationship course. This study is one of the 3 studies included in a PhD on learning process during simulation training in psychiatry. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Undergraduate Medical Students' Learning Process in Doctor-patient Relationship Training
- What is being tested?
- lecture, Simulation using Role play and Discussion group
- How many people
- 404 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jun 2018to 30 Jun 2018
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Undergraduate medical fourth-years student of Paris Descartes University. To diversify recruitment of students for semi-structured interview, investigators will conduct a drawing of lot, thanks to a computer programm, until data saturation. Apprenticeship trace will also be drawn of lot, until data saturation.
Who may be able to join
- Age > to 18 years old
- Undergraduate medical fourth-year student of Paris Descartes University
- Taking part in an obligatory doctor-patient relationship training, including role play, simulated consultation, Balint group and courses
- Draw by lot
- French or English language
- Agreement
Who cannot join
- Refusal of agreement
- Undergraduate medical fourth-year student of Paris Descartes University who couldn't take part in an obligatory doctor-patient relationship training, including role play, simulated consultation, Balint group and courses
Trial locations and contacts
1 site in 1 country.
France1 site
Paris Descartes University, Sorbonne Paris City, Faculty of Medicine
Paris, 75005
About this study
Official title: Learning Process of Fourth Year Medical Students During an Obligatory Doctor-patient Relationship Training, Including Role Play, Simulated Consultation, Balint Group and Courses: a Mixed Method Study
This study aims to explore learning process for undergraduate students in this doctor-patient relationship course. This study is one of the 3 studies included in a PhD on learning process during simulation training in psychiatry. The results of this 3 studies will aim at building a formative and summative assessment tool of competences specific to this pedagogic context.
Read the detailed description
Methodology: Mixed method study with:
Qualitative : Grounded Theory analysis of :
- Semi-structured interview of learners and teachers
- Learning written traces of students
Quantitative features:
- Self-reported questionnaires on satisfaction
- Sociodemographical data and others questions
- Being tested
- lecture, Simulation using Role play, Discussion group, Simulation using Simulated patient
- Keywords
- Simulation training, role-play, psychiatry, students, medical, psychology, educational, learning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lectureOther
Also called Empathy and doctor-patient relationship
- Empathy (1 hour)
- Doctor- patient relationship (1, 5 hour)
Simulation using Role playOther
Also called Doctor-patient relationship role play
- serious illness announcement
- abuse demand management
- reticent patient management
Discussion groupOther
Also called Balint Group
Share about clinical work experience and elaboration about psychoaffective and relational challenge
Simulation using Simulated patientOther
Also called Objective Structured Clinical Examination (OSCE)
- HIV announcement
- Refuse of antibiotic prescription
What is being measured
The primary outcome is the main question the study is designed to answer.
Learning processes
Learning processes according to students and teachers' perspective evaluated by face-to-face semi-structured interviews, faced with analysis of students' written apprenticeship traces
Measured: 2 hours
Secondary outcomes (1)
supporting or preventing factors of learning
according to students and teachers' perspective evaluated by face-to-face semi-structured interviews, faced with analysis of students' written apprenticeship traces
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start2 Jun 2018
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Undergraduate Medical Students' Learning Process in Doctor-patient Relationship TrainingStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Friedlander, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Marie-Aude PIOT, MD, PhD, Principal investigator, Paris Descartes University, FranceBruno FALISSART, MD, PhD, Study chair, Paris Saclay South University, Faculty of medicine, Orsay, FranceAntoine TESNIERE, Md, PhD, Study chair, University of Paris 5 - Rene Descartes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559998
- Sponsor's protocol ID
- NI18026HLJ
- Other IDs
- 2018-A00385-50
- Acronym
- APTHERA
- Status last verified
- Mar 2026
- First submitted
- 6 Jun 2018
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: For data about satisfaction and sociodemographic, it will be collected on a commun and secured base so as to support confrontation of analysis. For qualitative data, they will be kept on secured informatics interface (of Dr Marie-Aude Piot) of University Hospital Institute "Mutualiste Montsouris". The qualitative researchers will have access to this base for data quotation.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning Process of Fourth Year Medical Students During an Obligatory Doctor-patient Relationship Training, Including Role Play, Simulated Consultation, Balint Group and Courses: a Mixed Method Study
- ClinicalTrials.gov ID
- NCT03559998
- Acronym / sponsor ID
- APTHERA / NI18026HLJ
- Keywords
- Simulation training, role-play, psychiatry, students, medical, psychology, educational, learning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Fondation Friedlander, URC-CIC Paris Descartes Necker Cochin
- Study start
- 2 Jun 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 18 Jun 2018 (actual)
- 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.
This study aims to explore learning process for undergraduate students in this doctor-patient relationship course. This study is one of the 3 studies included in a PhD on learning process during simulation training in psychiatry. The results of this 3 studies will aim at building a formative and summative assessment tool of competences specific to this pedagogic context.
Detailed description
Methodology: Mixed method study with:
Qualitative : Grounded Theory analysis of :
- Semi-structured interview of learners and teachers
- Learning written traces of students
Quantitative features:
- Self-reported questionnaires on satisfaction
- Sociodemographical data and others questions
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Undergraduate medical fourth-years student of Paris Descartes University. To diversify recruitment of students for semi-structured interview, investigators will conduct a drawing of lot, thanks to a computer programm, until data saturation. Apprenticeship trace will also be drawn of lot, until data saturation.
Key inclusion criteria (6 listed)
- Age > to 18 years old
- Undergraduate medical fourth-year student of Paris Descartes University
- Taking part in an obligatory doctor-patient relationship training, including role play, simulated consultation, Balint group and courses
- Draw by lot
- French or English language
Key exclusion criteria (2 listed)
- Refusal of agreement
- Undergraduate medical fourth-year student of Paris Descartes University who couldn't take part in an obligatory doctor-patient relationship training, including role play, simulated consultation, Balint group and courses
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 |
|---|---|---|
| lectureAlso: Empathy and doctor-patient relationship* Empathy (1 hour) * Doctor- patient relationship (1, 5 hour) | Other | – |
| Simulation using Role playAlso: Doctor-patient relationship role play* serious illness announcement * abuse demand management * reticent patient management | Other | – |
| Discussion groupAlso: Balint GroupShare about clinical work experience and elaboration about psychoaffective and relational challenge | Other | – |
| Simulation using Simulated patientAlso: Objective Structured Clinical Examination (OSCE)* HIV announcement * Refuse of antibiotic prescription | Other | – |
Primary outcome
Learning processes
Time frame: 2 hours
Learning processes according to students and teachers' perspective evaluated by face-to-face semi-structured interviews, faced with analysis of students' written apprenticeship traces
1 secondary outcome
supporting or preventing factors of learning
Time frame: 2 hours
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 27 Mar 2026.
- Individual participant dataSharing planned: Yes. For data about satisfaction and sociodemographic, it will be collected on a commun and secured base so as to support confrontation of analysis. For qualitative data, they will be kept on secured informatics interface (of Dr Marie-Aude Piot) of University Hospital Institute "Mutualiste Montsouris". The qualitative researchers will have access to this base for data quotation.
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.
Marie-Aude PIOT, MD, PhD principal investigator
Paris Descartes University, France
Bruno FALISSART, MD, PhD study chair
Paris Saclay South University, Faculty of medicine, Orsay, France
Antoine TESNIERE, Md, PhD study chair
University of Paris 5 - Rene Descartes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Undergraduate Medical Students' Learning Process in Doctor-patient Relationship Training, run by Assistance Publique - Hôpitaux de Paris 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 6 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 27 Mar 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?
Learning processes (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2026.