RÉSUMÉ
AIM: Most toddlers experience pain and distress during doctor or dental visits. Aim of this systematic review was to investigate the role of play-based interventions in pain and fear or distress management in pre-school children (aged from 2 to 6 years old) undergoing needle-related medical procedures adhering to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines (registration number: CRD42020192161). METHODS: The key database that was searched was PubMed/MEDLINE along with references of relevant review studies. Only randomised controlled trials (RCTs) that fulfilled inclusion and eligibility criteria were selected for analysis. Methodological quality was evaluated using the Cochrane Collaboration's Risk of Bias Tool for RCTs and Review Manager version 5.4 was utilised in order to calculate standardised mean differences (SMDs) and create a forest plot for included studies that presented data on self-reported pain ratings. Primary outcomes refer to pain, anxiety and fear assessments, while secondary outcomes refer to physiological measures and cortisol levels. RESULTS: All included RCTs suffered from high risk of bias that relied on selection and blinding methodology, while other sources of bias were also present in some cases. Despite low-quality of evidence, play-based interventions seem to favour less self-reported pain (SMD -0.39; 95% CI: -0.67 to -0.12; I2 = 84%). CONCLUSION: Limitations of evidence, except from high risk of bias, include inconsistency in reporting primary outcome assessments and study designs that preclude reproducibility. Play-based techniques seem to contribute to pre-schoolers' coping towards needle-related medical procedures and further research is warranted in order to explore clinical benefits.