Abstract
BACKGROUND: Pain and emotional distress are prevalent concerns in pediatric hospital care, underscoring the need for safe and evidence-based nonpharmacological interventions. Socially assistive robots (SARs) are innovative tools that alleviate pain and emotional distress through social interaction. Although previous reviews suggest potential benefits, the evidence remains ambiguous, with insufficient exploration of the contextual factors influencing the effective implementation. OBJECTIVE: This systematic review with meta-analysis evaluates the effectiveness of SARs in reducing pain and emotional outcomes in pediatric hospital settings and identifies methodological, contextual, and ethical factors informing future implementation. METHODS: Following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 2020, 8 databases (PubMed, MEDLINE, Embase, Cochrane Library, Scopus, IEEE Xplore, Health & Medical Collection, and ProQuest Dissertations & Theses A&I) were searched until October 7, 2025. Eligible studies were randomized controlled trials involving participants aged <19 years in hospital settings. Two reviewers independently screened, extracted data, assessed risk of bias, and evaluated the certainty of evidence. Random-effects meta-analyses were performed using the Hartung-Knapp-Sidik-Jonkman method. Both CIs and prediction intervals (PI) were interpreted. RESULTS: Thirteen randomized controlled trials were included, of which 7 were eligible for meta-analyses. The narrative synthesis, incorporating intervention characteristics and contextual factors, suggested potential psychological benefits. For pain, a pooled analysis of 5 trials showed a significant reduction favoring SARs (difference in means=-0.89, 95% CI -1.32 to -0.47; 95% PI -1.29 to -0.49; I²=11.9%, τ²<0.0001, τ<0.01). For anxiety (3 trials; difference in means=-1.00, 95% CI -2.44 to 0.44; 95% PI -3.45 to 1.45; I²=73.8%, τ²=0.217, τ=0.466), fear (2 trials; difference in means=-0.04, 95% CI -1.72 to 1.64; I²=0%, τ²=0), and distress (2 trials; difference in means=-0.23, 95% CI -6.00 to 5.54; I²=65%, τ²=0.269, τ=0.519), pooled effects were nonsignificant with wide PIs. The GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) assessment indicated an overall moderate certainty of evidence, limited primarily by the risk of bias, due to the nonblinded nature of the interventions and the small number of studies. CONCLUSIONS: SARs may serve as promising nonpharmacological adjuncts for pediatric pain management, demonstrating consistent and reproducible benefits across similar hospital contexts. In contrast, the evidence for emotional outcomes remains ambiguous. The PI indicating that while some children may experience emotional benefits, others may show null or even opposite effects. This variability highlights the real-world implications for the clinical implementation of SARs. Moreover, this study offers an innovative integration of contextual, ethical, and technological perspectives into a comprehensive synthesis, providing a multidimensional understanding of how SARs function within pediatric health care environments. Future research should adopt rigorous designs and incorporate ethical considerations to optimize effects and ensure sustainable implementation of SARs in pediatric health care. TRIAL REGISTRATION: PROSPERO CRD420251026751; https://www.crd.york.ac.uk/PROSPERO/view/CRD420251026751.