Care Robots as Emerging Health Technologies: Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Background: Global aging and health care workforce shortages are increasing demand for therapeutic support among older adult and pediatric populations. Care robots, an umbrella term for socially assistive robots, companion and pet platforms, and therapeutic humanoids sharing a social interaction component, have been proposed as embodied digital health adjuncts, but prior syntheses have remained population- or platform-specific, leaving cross-population and cross-platform effects unquantified. Objective: This review quantifies the pooled effects of care-robot interventions across 7 prespecified outcome domains, examines robot platform, target population, and intervention-duration moderators, and grades evidence certainty. Methods: Following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 2020, we searched 5 databases (PubMed, including MEDLINE, Embase, Cochrane CENTRAL, CINAHL, APA PsycINFO) and 2 trial registries (ClinicalTrials.gov; World Health Organization International Clinical Trials Registry Platform) through April 29, 2026, with no language restriction. Eligible studies were randomized controlled trials of embodied care robots versus standard care, active controls, or waitlist. Random-effects meta-analysis used Hedges g with Hartung-Knapp-Sidik-Jonkman correction; for domains with k≥4, we report 95% CIs and prediction intervals (PIs). Risk of bias used the Cochrane Risk of Bias 2 tool; certainty used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework. Results: A total of 34 randomized controlled studies (n=2476; 17 countries; 2015-2024) met inclusion criteria; 20 contributed to at least 1 meta-analysis, and 14 entered narrative synthesis. Under Hartung-Knapp-Sidik-Jonkman pooling, only neuropsychiatric symptoms reached significance: Hedges g=0.44 (95% CI 0.03-0.84; 95% PI -0.42 to 1.30; k=6; P=.04). The remaining 6 domains were favorable but nonsignificant: quality of life Hedges g=0.15 (95% CI -0.41 to 0.71; 95% PI -0.86 to 1.16; k=5); depression Hedges g=0.20 (95% CI -0.08 to 0.49; 95% PI -0.36 to 0.76; k=7); agitation Hedges g=0.32 (95% CI -0.07 to 0.71; 95% PI -0.26 to 0.89; k=4); stress and pain Hedges g=0.53 (95% CI -0.48 to 1.53; 95% PI -1.57 to 2.62; k=6); social-communicative skills Hedges g=0.45 (95% CI -0.52 to 1.42; 95% PI -1.66 to 2.56; k=5); and cognitive function Hedges g=0.18 (95% CI -0.62 to 0.98; 95% PI -1.11 to 1.47; k=4). All 7 PIs encompassed the null, indicating no assured effect in new settings. The neuropsychiatric symptom result was fragile: significance was lost in 5 of 6 leave-one-out iterations and on excluding Petersen 2016 (data extraction ambiguity), yielding a Hedges g of 0.40 (P=.10). GRADE certainty was low for neuropsychiatric symptoms and very low for the remaining 6 domains. Conclusions: Across cross-population, cross-platform randomized controlled trial pooling, the evidence does not yet support routine clinical adoption of care robots. Potential benefits are narrow, of low certainty, and contingent on adequately powered multicenter confirmatory trials with PI-informed sample sizes. Care robots are best framed as facilitator-supported adjuncts that augment, rather than substitute for, human-delivered care.