BackgroundThe healthcare setting is stressful for many people, especially children. Efforts are needed to mitigate children’s healthcare-related anxiety. Medical play using the Teddy Bear Hospital (TBH) concept can expose children to healthcare settings and help them develop positive experiences in these settings. In this role-playing game, children bring their soft toys and act as parents to the ‘sick’ teddies in a pretend hospital or clinic play setting. The objective of this systematic review is to evaluate the effectiveness of the TBH in improving children’s health outcomes and well-being.MethodsWe searched the reference lists of included studies from four electronic databases (PubMed, CINAHL, Scopus and Google Scholar) from inception until November 2020. We included pre-post, quasiexperimental and case–control studies, as well as randomised controlled trials (RCTs) that discussed medical play using the TBH concept as an intervention. Studies that involved sick patients and used interventions unlike the TBH were excluded. We assessed the quality of the included studies using the Cochrane Collaboration’s ‘Risk of bias’ tool.ResultsTen studies were included in this systematic review. Five specifically investigated the TBH method, while the others involved the same concept of medical play. Only three studies were RCTs. All of the studies report more than one outcome—mostly positive outcomes. Two report lower anxiety levels after intervention. Two found better healthcare knowledge, with one reporting increased feelings of happiness regarding visiting a doctor. Two studies found no change in anxiety or feelings, while another two found increased levels of fear and lowered mood after the medical play (which involved real medical equipment).ConclusionsThe practice of TBH has mostly positive outcomes, with lower anxiety levels and improved healthcare knowledge. Its effectiveness should be verified in future studies using a more robust methodology.PROSPERO registration numberCRD42019106355.