EmpathyEMPATHIENCT02681380
Impact of a Relation Training on Empathy of Medical Student
A study testing Relation learning in people with Empathy, run by University of Paris 5 - Rene Descartes.
Trial summary
Empathy is an important skill to learn for medical student. However, learning empathy remain difficult. The investigators aim was to assess the efficacy of a specific training, Balint like, on the empathy abilities of medical students in the 4th year. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Empathy
- What is being tested?
- Relation learning
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 352 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to May 2016
- 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
- Medical student in the 4th year
Who cannot join
- None
About this study
Official title: Impact of a Relation Training, Balint-like, on Empathy of Medical Student in the 4th Year.
Empathy is an important skill to learn for medical student. However, learning empathy remain difficult. The investigators aim was to assess the efficacy of a specific training, Balint like, on the empathy abilities of medical students in the 4th year. The investigators planned a randomized controlled trial in 3 universities.
- Conditions
- Empathy
- Being tested
- Relation learning, Control group
- Keywords
- simulated patient, Balint, empathy, medical student
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relation learningOther
Seven session are planned. Each will be supervised by a senior, trained to supervised Balint group.
Control groupOther
No session will be planned for the participants.
| Study group | Role | What they receive |
|---|---|---|
| Relation learning | Experimental | Participants of this group will benefit form a specific learning on relation, Balint like. They will have 7 sessions during 3 months. Receives: Other: Relation learning |
| Control group | Placebo comparator | Participants of this group will have no learning related to relation with patient. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Care
Scale to measure empathy by a simulated patient, during a simulated visit
Measured: Two weeks after the last session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study startSep 2015
- Primary completionMar 2016
- Study completionMay 2016
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 EmpathyStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Paris 5 - Rene Descartes
- Sponsor type
- University, hospital or other
- Collaborators
- University Paris 7 - Denis Diderot, University of Paris 13
- Responsible party
- Principal investigator, Céline Buffel du vaure, University of Paris 5 - Rene Descartes
- Investigators
- Philippe Jaury, Principal investigator, University Paris 5
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681380
- Sponsor's protocol ID
- 01004
- Acronym
- EMPATHIE
- Status last verified
- Jul 2016
- First submitted
- 9 Feb 2016
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Buffel du Vaure C, Lemogne C, Bunge L, Catu-Pinault A, Hoertel N, Ghasarossian C, Vincens ME, Galam E, Jaury P. Promoting empathy among medical students: A two-site randomized controlled study. J Psychosom Res. 2017 Dec;103:102-107. doi: 10.1016/j.jpsychores.2017.10.008. Epub 2017 Oct 17.
PubMed 29167035
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Relation Training, Balint-like, on Empathy of Medical Student in the 4th Year.
- ClinicalTrials.gov ID
- NCT02681380
- Acronym / sponsor ID
- EMPATHIE / 01004
- Conditions
- Empathy
- Keywords
- simulated patient, Balint, empathy, medical student
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- University of Paris 5 - Rene DescartesUniversity, hospital or other
- Collaborators
- University Paris 7 - Denis Diderot, University of Paris 13
- Study start
- Sep 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 12 Feb 2016 (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.
Empathy is an important skill to learn for medical student. However, learning empathy remain difficult. The investigators aim was to assess the efficacy of a specific training, Balint like, on the empathy abilities of medical students in the 4th year. The investigators planned a randomized controlled trial in 3 universities.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Relation learning | Experimental | Other: Relation learningParticipants of this group will benefit form a specific learning on relation, Balint like. They will have 7 sessions during 3 months. |
| Control group | Placebo comparator | Other: Control groupParticipants of this group will have no learning related to relation with patient. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Medical student in the 4th year
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Relation learningSeven session are planned. Each will be supervised by a senior, trained to supervised Balint group. | Other | Relation learning |
| Control groupNo session will be planned for the participants. | Other | Control group |
Primary outcome
Care
Time frame: Two weeks after the last session
Scale to measure empathy by a simulated patient, during a simulated visit
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 13 Jul 2016.
- Derived from this study: PubMed 29167035Buffel du Vaure C, Lemogne C, Bunge L, Catu-Pinault A, Hoertel N, Ghasarossian C, Vincens ME, Galam E, Jaury P. Promoting empathy among medical students: A two-site randomized controlled study. J Psychosom Res. 2017 Dec;103:102-107. doi: 10.1016/j.jpsychores.2017.10.008. Epub 2017 Oct 17.
- Individual participant dataSharing planned: Undecided
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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.
Philippe Jaury principal investigator
University Paris 5
Questions about this trial
What is this clinical trial studying?
A study testing Relation learning in people with Empathy, run by University of Paris 5 - Rene Descartes.
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 1 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 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Care (time frame: Two weeks after the last session). 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 NCT02681380, 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 13 Jul 2016.