NCT02681380

Brief 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. The investigators planned a randomized controlled trial in 3 universities.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
352

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 12, 2016

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

July 13, 2016

Status Verified

July 1, 2016

Enrollment Period

6 months

First QC Date

February 9, 2016

Last Update Submit

July 12, 2016

Conditions

Keywords

simulated patientBalintempathymedical student

Outcome Measures

Primary Outcomes (1)

  • Care

    Scale to measure empathy by a simulated patient, during a simulated visit

    Two weeks after the last session

Study Arms (2)

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.

Other: Relation learning

Control group

PLACEBO COMPARATOR

Participants of this group will have no learning related to relation with patient.

Other: Control group

Interventions

Seven session are planned. Each will be supervised by a senior, trained to supervised Balint group.

Relation learning

No session will be planned for the participants.

Control group

Eligibility Criteria

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

You may qualify if:

  • Medical student in the 4th year

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Philippe Jaury

    University Paris 5

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 9, 2016

First Posted

February 12, 2016

Study Start

September 1, 2015

Primary Completion

March 1, 2016

Study Completion

May 1, 2016

Last Updated

July 13, 2016

Record last verified: 2016-07