ObjectivesTo explore the effectiveness of two educational strategies for teaching empathy to medical students, focusing on their skills and on the theoretical knowledge and self-perception of empathy by patients, professors, and observers. MethodsThis is a randomized controlled study. Clerkship students were divided into two groups: an active group - Role Play and Reflection Group(RRG), and a more traditional group - Lecture Presentation Group(LPG). They were assessed pre- and post-intervention using the Jefferson Empathy Scale(JSPE), ESWIM Empathy Scale, CARE, empathic skills through simulated patient encounters, and a theoretical knowledge test. ResultsA total of 169 students were included. The RRG had higher scores (d=0.81) and greater gains (d=0.82) in empathic skills than the LPG. However, there were no significant differences in knowledge or other scales. Upon assessing skill acquisition (Post–Pre gains), there was a significant increase in both groups for all outcomes, except for JSPE in the LPG group and ESWIM for both groups. ConclusionMedical empathy can be taught, and active learning methodologies can lead to better outcomes, especially on the ability to provide empathic care. Practice implicationsThese findings reinforce existing literature and helps medical schools make informed decisions regarding their teaching methodologies. Trial registryhttps://ensaiosclinicos.gov.br/rg/RBR-8rwx89c.