Category: 3. Business

Introduction

Pain is defined as “an unpleasant sensory and emotional experience associated with, or resembling actual or potential tissue damage” []. In pediatric health care, pain is one of the most frequently reported concerns, and when inadequately managed, it may lead to long-term physical, psychological, and developmental consequences [,]. These risks underscore the urgent need for effective and safe pain management strategies tailored for children.

Current clinical recommendations emphasize multimodal approaches that integrate both pharmacological and nonpharmacological strategies to optimize outcomes in the pediatric population [,]. Pharmacologically, ibuprofen is the most extensively studied nonsteroidal anti-inflammatory drug and is widely recognized for its efficacy and safety in acute pediatric pain []. However, best practice not only achieves effective analgesia but also aims to minimize risks by reducing overreliance on pharmacological interventions and incorporating evidence-based nonpharmacological approaches [,].

In this context, socially assistive robots (SARs) have emerged as a promising nonpharmacological intervention for alleviating pain and mitigating emotional distress in pediatric health care settings [-]. Through features such as embodiment, personalization, empathy, and attentional distraction, SARs provide emotionally supportive interactions without requiring physical contact []. Evidence indicates that SARs can reduce procedural pain, anxiety, and distress while promoting positive affect and supporting postoperative recovery [-].

This potential is particularly relevant in hospital environments, where children frequently undergo painful and distressing medical procedures, such as injections, blood draws, surgeries, and cancer treatments [-]. Inadequately managed pain and distress in these settings may contribute to delayed recovery, prolonged hospitalization, long-term psychological sequelae, and reduced treatment adherence []. Compared with outpatients, hospitalized children are more often exposed to repeated and invasive procedures, making effective emotional support and pain management especially critical [].

Despite the growing interest, most existing systematic reviews of SARs have focused on outpatient applications, particularly in mental health or short-term procedural contexts, such as vaccinations and dental visits [,,,]. A few meta-analyses have examined SARs in clinical settings for outcomes such as anxiety [], pain and negative affect during needle-based interventions [], and psychological well-being []. Emotional responses are inherently subjective experiences [,]. However, previous meta-analyses included a blend of observer-rated and self-reported outcome measures. This study prioritized children’s self-reports, which are more accurately captured through their own perspective.

Furthermore, research on human-robot interaction highlights that the clinical implementation of SARs requires careful consideration of ethical dimensions, such as safety, privacy, and autonomy [,]. Ethical concerns also include children’s potential emotional overdependence, unintentional attachment, and reduced meaningful human interaction, which are especially salient for younger patients undergoing emotional and social development [,]. However, these dimensions have received limited systematic attention in pediatric care.

To address these gaps, this systematic review with meta-analysis synthesizes findings exclusively from randomized controlled trials (RCTs) that evaluated the effectiveness of SARs in reducing pain and emotional outcomes, including anxiety, fear, and distress, among pediatric patients in hospital settings. In addition, this study provides a comprehensive synthesis of intervention design and contextual factors for future RCTs, ultimately improving clinical outcomes and enhancing children’s hospital experiences.

Methods

Study Design

This review was prospectively registered in the PROSPERO (International Prospective Register of Systematic Reviews; CRD420251026751). This study followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 2020 guidelines [] and the PRISMA-S (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Literature Search Extension) extension for literature searches (checklist provided in ) []. The search strategy was peer reviewed by a senior medical librarian before execution using the PRESS (Peer Review of Electronic Search Strategies) guidelines to ensure transparency, reproducibility, and methodological rigor []. Two reviewers independently conducted the study selection, risk of bias assessment, certainty of evidence appraisal, and data extraction. Discrepancies were resolved through discussions with a third reviewer and the corresponding author.

Eligibility Criteria

This review included RCTs that met the following eligibility criteria according to the PICO framework: (1) population (P): participants were children <19 years of age in hospital settings; studies focusing on children diagnosed with autism spectrum disorder were excluded, as previous research has already established the efficacy of SARs in this population []; (2) intervention (I): involved the use of SARs, excluding studies focused on rehabilitation, training, or surgical applications; (3) comparison (C): studies included control or alternative intervention; and (4) outcomes (O): the primary outcome was pain. Secondary outcomes were emotion-related responses.

Information Sources

A total of 8 electronic databases across 5 platforms were searched to identify relevant studies: PubMed (National Library of Medicine), MEDLINE (National Library of Medicine), Embase (Elsevier), Cochrane Library (Wiley), Scopus (Elsevier), IEEE Xplore Digital Library (IEEE Xplore), Health & Medical Collection (ProQuest), and ProQuest Dissertations & Theses A&I (ProQuest). To identify additional gray literature and unpublished studies, we searched the study registry ClinicalTrials.gov and manually screened conference proceedings from the Proceedings of the 2025 ACM/IEEE International Conference on Human-Robot Interaction. Both cited and citing references of relevant systematic reviews were examined by browsing their reference lists and using Google Scholar’s (Google LLC) citation function to identify additional eligible studies.

Search Strategy

An iterative search strategy was developed following the PRISMA-S extension for the transparent and reproducible reporting of literature searches. The strategy combined Medical Subject Headings, related terms, and free-text keywords using Boolean operators to optimize the sensitivity and specificity. Search concepts were informed by the PICO framework and included terms related to “hospitalization,” “child,” “social robot,” “pain,” “distress,” “emotion,” “anxiety,” “fear,” and “well-being.” The search syntax was subsequently adapted to each database’s indexing system. The initial search was conducted on May 6, 2025, and updated on October 7, 2025, by rerunning the searches. No language or publication date restrictions were applied. The details of the search strategies, including full line by line search strings, filters, parameters, search dates, and retrieval counts, are presented in .

Selection Process

All references were imported into EndNote (version 21; Clarivate), and the duplicates were automatically removed. Titles and abstracts were independently screened by 2 reviewers, followed by full-text assessments based on predefined eligibility criteria. The reasons for exclusion are documented in . The overall selection process is illustrated in the PRISMA flow diagram in the Results section.

A total of 1229 records were retrieved from 8 databases and 1 from citation searching. After removing 216 duplicates and screening titles or abstracts, 80 full texts were assessed. After 67 were excluded due to not meeting the criteria, 13 studies were included, with 7 providing sufficient data for meta-analysis.

Quality Assessment

The methodological quality of the included RCTs was evaluated using the short version of the revised Cochrane Risk of Bias tool for randomized trials []. The risk of bias was assessed across 5 domains: randomization process, deviations from intended interventions, missing outcome data, outcome measurement, and selection of reported results. Each domain was rated as “low risk,” “some concerns,” or “high risk” of bias, and an overall judgment was made.

Certainty of Evidence

The certainty of evidence for each outcome was assessed using the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) approach []. Five domains were evaluated: risk of bias, inconsistency, indirectness, imprecision, and publication bias. Outcomes were rated as “high,” “moderate,” “low,” or “very low” certainty of evidence. The ratings were generated using the GRADEpro Guideline Development Tool [].

Data Extraction and Synthesis

The data extraction included study characteristics such as authors, year of publication, country, study objectives, sample size, study population, participant age, setting, type of SARs, intervention details, comparator, measurement tools, and main findings. All the included studies contributed to the narrative synthesis. For the meta-analysis, only studies that provided sufficient numerical data were eligible for pooling, regardless of whether the outcome was primary (pain) or secondary (emotional responses). Where such data (eg, means, SDs, and sample sizes) were incomplete, we attempted to contact the original study authors to obtain additional information. Data synthesis was conducted in two parts: (1) narrative synthesis, summarizing key characteristics and findings of all included studies; and (2) meta-analysis, performed for outcomes with adequate quantitative data.

Data Analysis

Meta-analyses were conducted using R version 4.2.1 (R Project for Statistical Computing). Pooled effect sizes were estimated using a random-effects model to account for anticipated heterogeneity []. The outcomes included pain, anxiety, distress, and fear. For each outcome, differences in means with corresponding 95% CIs were calculated to accommodate variability across measurement scales. Subgroup analyses or meta-regression were planned in the presence of substantial heterogeneity. Given the limited number of studies, the Hartung-Knapp-Sidik-Jonkman method was applied to adjust the SEs []. Between-study heterogeneity was quantified using the inconsistency index (I²), between-study variance (τ²) and SD (τ), and 95% prediction intervals (PI) were reported to indicate the expected range of effects in future studies, except for outcomes with very few studies []. Forest plots were generated to visualize the pooled effect sizes. Funnel plots were constructed to assess the small-study effect. As recommended, Egger test was not performed for outcomes with fewer than 10 studies because of its low statistical power to detect true asymmetry [,].

Results

Literature Search

As illustrated in , a total of 1229 records were retrieved from 8 electronic databases (), with no additional records retrieved through other methods. After removing 216 duplicates, 1013 records remained for review. Title and abstract screening excluded 933 papers based on the predefined inclusion and exclusion criteria, resulting in 80 papers for full-text reviews. Of these, 67 were excluded because they did not meet the eligibility criteria (). Ultimately, 13 RCTs were included in this review. The details of the search strategies are presented in .

Characteristics of Included Studies

The characteristics of the 13 included RCTs are shown in . All studies were published between 2013 and 2023 and were conducted in 6 countries: Canada, the United States, Italy, Iran, Turkey, and Taiwan. A total of 619 participants were enrolled (intervention group: 301 and control group: 318), with individual study sample sizes ranging from 11 to 103. Participants were aged 2-19 years, most of whom were of school age, and all were in pediatric hospital settings due to acute illness, chronic disease, or surgical procedures. Additionally, the settings in which the interventions were implemented were diverse. Two trials were conducted in emergency departments [,], 2 in surgical wards and operating rooms [,], 2 in oncology units or hematology clinics [,], 3 in pediatric wards [-], 1 in a postanesthesia care unit [], 1 in a radiology department [], 1 in a hospice unit [], and 1 in a hospital-based game room [].

Design of SARs Interventions and Comparators

The included interventions varied in terms of timing, frequency, and technological features (). Six studies implemented SARs before or during invasive procedures [,,,,,], 4 addressed broader hospital experience contexts [,,,], 2 focused on preoperative care [] or postoperative care [], and 1 was conducted before a noninvasive procedure []. The intervention duration ranged from 3 to 40 minutes; 11 studies used a single session, while 2 adopted repeated sessions [,]. SARs primarily provide distraction, cognitive behavioral strategies, and emotional companionship. Technical difficulties were reported in 4 studies [,,,], mainly due to connectivity or hardware malfunctions, with rates ranging from 9% (4/46) to 60% (26/43).

Across the 13 included RCTs, 6 studies compared the SARs interventions with standard hospital care. The remaining 7 studies used diverse comparators, including psychologist-led therapy [], another robotic platform [], an alternative SARs-based distraction program [], a plush teddy bear [], audiobooks delivering the same narratives [], being alone with the SARs [], and nurse-led postoperative recovery []. These variations in comparator conditions illustrate the heterogeneity of approaches in contextualizing the role of SARs in pediatric care.

Nine types of SARs were used in the included studies (). Their physical appearances can be broadly categorized as humanoid (eg, NAO byAldebaran, Pepper bySoftBank, and Arash), animal-like (Huggable and Paro by National Institute of Advanced Industrial Science and Technology), or robot-like (Sanbot by Sanbot, Kebbi by Nuwa, MAKI, and Macrobot by Silverlit). Most SARs interacted with children using voice and gestures, and visual aids through camera input. Humanoid robots typically feature advanced functions, such as facial expression recognition and tactile feedback. The operational modes varied across autonomous, hybrid, and teleoperated systems. Cost information was available in only 2 studies: Arash (US $6000) [] and MAKI (US $2985) []. The price of Macrobot (US $27-$78) [] was obtained from commercial retail websites. For the other SARs, pricing information was obtained from the manufacturer’s specifications. Overall, 6 SARs were commercially available products, whereas Huggable and Arash were developed in research laboratories, and MAKI was custom-fabricated using 3D printing technology.

Risk of Bias and GRADE Assessment

Eight studies were assessed as having some concerns regarding the overall risk of bias [-,,,,,], and 4 were assessed as having a high risk of bias [,,,]. The most frequent high-risk domains were deviations from the intended interventions (domain 2) and measurement of the outcome (domain 4; ). As the SARs intervention could not be blinded, some concerns were particularly identified in domain 2, where 1 trial [] was rated as high risk because its control group may have had an active role beyond that of passive control, potentially influencing the comparison with the intervention group. Two other studies were rated as high risk in domain 4 because the individuals assessing the outcomes also participated in the intervention, which may have introduced observer bias [,]. Additionally, 1 trial was rated as having a high risk of missing outcome data because it did not report 2 missing participants [].

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According to the GRADE assessment, all outcomes were rated as moderate-certainty evidence (). Pain reduction showed moderate-certainty evidence when compared with both standard and alternative care. Anxiety and fear reduction were also rated as moderate, indicating potential benefits but inconclusive effects. Distress reduction was similarly rated as moderate, supported by a single trial. Overall, these outcomes are considered clinically important; however, the certainty of evidence was limited by the risk of bias and the small number of studies.

The risk of bias was evaluated across 5 domains. Most of the studies were identified as having some concerns, with deviations from the intended interventions (domain 2) being the most prevalent source of bias.

Narrative Synthesis

The outcomes of the 13 studies varied by domain (). For primary pain level measures in 6 studies, significant reductions were observed in 1 study [], whereas the other 5 [,,,,] reported no significant differences, reflecting mixed evidence regarding the analgesic benefits of SARs. As participant and personnel blinding were unfeasible in SARs interventions, 4 trials were rated with some concerns, and 2 were high-risk in reporting bias and comparator response bias. Secondary emotion-related outcomes were anxiety, fear, distress, emotional engagement, state positive and negative emotion, and stress level. Stress-related physiological outcomes were more consistent across 1 trial, which demonstrated significant decreases in both salivary cortisol and heart rate []. Anxiety outcomes showed clearer benefits, with 6 studies reporting significant reductions [,,,,,], while studies had some concerns or a high risk of bias due to observer bias. Three studies reported null effects of fear [,,]. Of the 2 studies [,], only 1 reported a significant reduction in distress []. For state emotions, SARs enhanced emotional engagement and positive emotions in 2 studies [,]. Additionally, 2 studies documented greater engagement with SARs and narrative immersion [,]. Detailed statistical findings of each study are presented in .

Meta-Analysis

Among the 13 included studies, 7 met the criteria for this meta-analysis, involving a total of 359 participants. Pain was the primary outcome, whereas anxiety, fear, and distress were secondary emotional responses (). All pooled estimates were calculated using the Hartung-Knapp-Sidik-Jonkman random-effects method, and PIs were displayed on the forest plots, except for outcomes with very few included studies, such as fear and distress. Funnel plots were generated for pain and anxiety to provide a visual assessment for small-study effect (). As the number of included studies was very limited (pain, n=5; anxiety, n=3; distress, n=2; and fear, n=2), no Egger tests were conducted [].

Pain

A total of 5 studies [,,,,] contributed data to the meta-analysis of pain outcomes, as illustrated in . The pooled analysis demonstrated a significant reduction favoring SARs interventions (difference in means=–0.89, 95% CI –1.32 to –0.47; 95% PI –1.29 to –0.49), with low heterogeneity (I²=11.9%, τ² < 0.0001, τ<0.01, P=.34). One study [] contributed the largest weight (85.1%), attributable to its smaller variance. The funnel plot showed slight asymmetry ().

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Anxiety

A total of 3 studies [,,] contributed to the meta-analysis of anxiety outcomes, as illustrated in . The random-effects model yielded a nonsignificant pooled effect (difference in means=–1.00, 95% CI –2.44 to 0.44; 95% PI –3.45 to 1.45), with substantial heterogeneity (I²=73.8%, τ²=0.2172, τ=0.466, P=.02). The funnel plot appeared symmetrical ().

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Fear

A total of 2 studies [,] contributed to the meta-analysis of fear outcomes, as illustrated in the forest plot (). The pooled analysis showed no significant effect of SARs interventions (difference in means=–0.04, 95% CI –1.72 to 1.64), with no detected heterogeneity (I²=0%, τ²=0, P=.53).

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Distress

A total of 2 studies [,] were in the meta-analysis of distress outcomes, as illustrated in . The pooled analysis showed no significant effect of SARs interventions (difference in means=–0.23, 95% CI –6.00 to 5.54) with substantial heterogeneity (I²=65%, τ²=0.2693, τ=0.519, P=.09).

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In summary, the meta-analysis provides evidence that SARs interventions may effectively reduce pain for children in the hospital. By contrast, the findings for anxiety, fear, and distress remain inconclusive due to nonsignificant pooled effects and considerable heterogeneity across studies.

Discussion

Principal Findings

This systematic review and meta-analysis synthesized evidence from 13 RCTs to evaluate the effectiveness of SARs in reducing pain and emotional outcomes, including anxiety, fear, and distress, among pediatric patients in hospital settings. Beyond the meta-analysis, our review conducted a comprehensive narrative analysis, integrating intervention characteristics and contextual factors to provide an understanding of real-world clinical implementation and future research design. Overall, the pooled analysis suggested that SARs interventions may offer beneficial effects for pain reduction, whereas their impact on emotional outcomes was not statistically significant. However, these findings should be interpreted with caution, given the presence of some concerns and high risks of bias in several domains, as well as the overall moderate certainty of evidence. Importantly, these results have practical relevance for health care providers and researchers, offering insights for future clinical implementation and study design aimed at adopting SARs as child-friendly and effective adjuncts in pediatric hospital care.

Pain

SARs interventions demonstrated a statistically significant reduction in children’s pain, providing moderate-certainty evidence that such interventions may help alleviate pain in hospital settings. Among the 5 studies synthesized, 1 trial [] was rated as high risk due to reporting bias and lack of blinding, while the others were rated as having some concerns. Notably, this high-risk study accounted for a large weight in the meta-analysis, suggesting that the pooled effect for pain may be disproportionately influenced by it and should therefore be interpreted with caution.

The PI was slightly narrower than, but consistent with, the effect of the CI. As prior studies [,], a narrower PI may indicate low between-study heterogeneity, which in this study could also reflect the large weighting of a single trial influencing the pooled estimate and reducing observed variability. This pattern suggests that similar beneficial effects may be observed under comparable conditions, but the limited evidence base warrants a conservative interpretation of these findings.

From a clinical perspective, these results imply that when intervention protocols, implementation settings, and participant characteristics are similar, clinicians may expect consistent and meaningful pain reduction with the use of SARs. In practice, SARs can provide distraction, emotional support, and engagement as adjuncts to standard pain management strategies. The combination of a statistically robust pooled effect and PI offers moderate yet credible evidence that SARs can reduce children’s pain perceptions during hospital-based procedures.

However, the duration of SARs interventions varied considerably across studies, revealing a lack of standardization in exposure time. Due to this variability, a dose-response relationship between intervention length and pain reduction could not be established. While short, single-session interventions may be well-suited for acute procedural pain, current evidence remains insufficient to confirm sustained benefits for children undergoing longer hospital stays. Collectively, these findings position SARs as promising, child-friendly adjuncts within multimodal pediatric pain management, though further methodologically rigorous and well-powered RCTs are needed to consolidate their clinical credibility, optimize implementation protocols, and determine long-term therapeutic potential.

Anxiety, Fear, and Distress

The emotional outcomes revealed a more complex and context-dependent pattern compared with the primary pain outcomes. Among the studies included in this review, SARs interventions appeared effective in reducing children’s anxiety when both self-reported and observer-rated measures were considered. However, the meta-analysis, which primarily focused on children’s self-reported anxiety scales, did not yield a statistically significant pooled effect. This divergence is likely attributable to differences in outcome measurement. Previous meta-analyses [-] reported significant reductions in anxiety, which typically combined observer-rated assessments with children’s self-reports, whereas our analysis distinguished between the two. This distinction reflects that anxiety, as an inherently subjective emotional experience, is best captured through the individual’s own perspective [,]. The nonsignificant result observed in our analysis aligns with prior evidence showing discrepancies between observer- and self-reported measures [], underscoring the need for further investigation into how these differing perspectives capture children’s emotional experiences. The overall moderate certainty of evidence reflects methodological limitations identified in the included trials, particularly the risk of bias from the nonblinded nature, inadequate statistical power, and reporting bias.

Furthermore, the CI reflects the average effect in this meta-analysis, while the wide PI illustrates the likely variation in true effects in future studies and clinical contexts [,]. The wide PI observed for anxiety suggests that the true effects of SARs may vary substantially across clinical contexts, indicating that while some settings may observe meaningful emotional benefits, others may experience null or even opposite effects. The statistical heterogeneity for anxiety and distress can be attributed to significant methodological and clinical context differences across the included trials. The studies varied widely in their clinical settings, study populations, intervention designs, and the specific features of SARs. Such variability likely reflects differences between included studies, rather than inconsistency in the underlying potential of SARs. This highlights the importance of contextual and implementation factors in shaping the emotional outcomes of SARs interventions. However, due to the limited number of studies, these findings should be interpreted with caution.

These contextual variations suggest that the effectiveness of SARs may be highly specific to a particular population, clinical context, or interaction mode. From a practical perspective, these findings emphasize the need for an approach grounded in real-world clinical contexts to ensure effective and meaningful integration of SARs into patient care. Overall, the evidence of SARs deployment for emotional support in pediatric hospital settings was limited, highlighting the need for more standardized trials to address these methodological and contextual variations.

Clinical and Practical Implications

The evidence from this review indicates that SARs represent an engaging and child-friendly adjunct for pain management in pediatric hospital settings. Our pooled results demonstrated a statistically significant reduction in pain, and the PI suggested that these benefits may be reproducible in similar clinical contexts. However, the current evidence for emotional outcomes remains limited and heterogeneous, emphasizing the need for caution in their implementation for psychosocial support.

The successful integration of SARs into clinical practice necessitates careful consideration of feasibility, ethical implications, and long-term sustainability. Clinically, SARs function primarily as assistants, supporting but not replacing human caregivers. Therefore, effective implementation requires comprehensive staff training in interaction protocols and hygiene management, alongside strong institutional support to ensure appropriate use and maximize clinical benefits. In addition, reliable technical support and regular maintenance are essential to sustain functionality, particularly in hospital settings that may have limited access to specialized technological personnel.

From an institutional perspective, performing a thorough cost-effectiveness analysis is essential. The initial acquisition costs of the SARs varied greatly and needed to be considered alongside the ongoing maintenance costs of hardware and software. A strategic evaluation of cost-effectiveness involving the adoption of innovative technologies, beginning with pilot studies to assess clinical feasibility before expanding to broader use, can further facilitate the full integration of SARs into health care settings.

Ethical Considerations

Ethical dimensions are critical for the implementation of SARs in pediatric hospital care, particularly regarding safety, privacy, and autonomy [,]. Only 4 of the 13 included studies addressed ethical considerations, primarily focusing on children’s physical and psychological safety [,,,]. The evidence currently offers limited insight into the broader ethical dimensions of human-robot interaction. Therefore, we expanded upon these critical ethical considerations.

Beyond safety, privacy is a crucial issue, requiring secure data storage, parental consent, and adherence to data protection standards [,,]. Psychological considerations and autonomy also warrant attention, while a few children may experience fear or negative experiences [,]. While SARs can provide comfort and support, some children may experience fear or discomfort [,,]. These risks intersect with the question of autonomy, particularly as children’s interactions with robots may influence their social and emotional development.

The automation level of SARs varied across included studies; notably, 11 trials used hybrid or operator-guided systems. Such approaches may represent the safest balance between technological novelty and patient safety in current clinical practice [,,,].

Strengths and Limitations

The primary strength of this review lies in its rigorous, systematic approach, coupled with the innovative integration of comprehensive contextual synthesis, cost-effectiveness, and ethical dimensions. The meta-analysis also allowed us to quantify and interpret the effect of SARs statistically. These contribute a framework for understanding SARs’ application relevant to real clinical practice.

However, several limitations should be acknowledged. The heterogeneity in methodological designs across included studies constrained the comparability of findings. The limited number of eligible trials presents a significant methodological constraint to performing subgroup analyses, particularly concerning statistical power. Although funnel plots were conducted to visually assess potential asymmetry, the small number of eligible trials constrained the reliable assessment of small-study effects (Egger test), as statistical power is limited with few studies []. Last, the moderate certainty of evidence underscores the need for greater methodological rigor in future research. In summary, these factors suggest that while the findings offer meaningful insights, they should be interpreted with appropriate caution and contextual awareness.

Future Research Directions

To address the risk of bias concerns identified in this review, future RCTs should adhere to rigorous methodological and reporting standards. Larger, well-designed, and adequately powered studies are warranted to reduce imprecision and enhance generalizability. As participant and personnel blinding are inherently unfeasible in SARs interventions, alternative strategies are suggested to minimize observer and response bias. These may include the use of blinded outcome assessors, standardized intervention protocols, and integrating objective indicators (eg, physiological parameters, objective behavioral indicators, speech emotion recognition, or facial expression recognition) to mitigate human influence during assessment.

As pain and emotions are inherently subjective experiences, self-reported measures remain the most direct indicators. However, combining validated self-report instruments with objective or observer-based assessments may provide a more comprehensive and balanced understanding. Transparent reporting of contextual and procedural factors will further facilitate comparability and reproducibility.

Moreover, research may expand beyond mitigating negative emotions to explore how SARs promote positive emotional responses and evaluate multisession interventions to determine sustained effects. Technological development is also crucial for improving system robustness, minimizing technical failures, and enhancing the usability of the operation. Notably, integrating ethical considerations, including child autonomy, privacy, and data protection, is essential for responsible future research.

Conclusion

This systematic review and meta-analysis suggest that SARs have potential as a valuable adjunct for pain management in pediatric hospital care. The observed reduction in pain across comparable clinical contexts indicates that SARs can provide consistent and clinically meaningful benefits when appropriately implemented. In contrast, the evidence for their effects on emotional outcomes remains ambiguous. The wide PI observed for anxiety suggests that the effects of SARs may vary substantially across clinical contexts, while some children may experience emotional benefits, others may show null or even opposite effects, highlighting the important role of contextual factors of SARs implementation. The overall concerns of risk of bias underscore the need for methodological rigor in future research to consolidate the evidence base.

At present, SARs can be regarded as a promising nonpharmacological tool for pain management. Their ethical and effective integration into pediatric practice requires adherence to clear principles that prioritize child-friendly care. Moving forward, research should combine technological innovation with psychosocial intervention design to evaluate the cumulative effects of multisession SARs interactions and to explore their potential to enhance positive emotions, engagement, and resilience. Through such evidence-driven and ethically grounded development, SARs may evolve into a vital component of child-centered digital health, fostering more positive and supportive health care experiences for children.

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Transactions of $10bn or more have hit an all-time record in 2025 after Donald Trump’s deregulatory push unleashed Wall Street’s animal spirits and a blitz of global dealmaking.

Naver’s $10.3bn all-stock acquisition of South Korea’s biggest crypto exchange Upbit on Wednesday took this year’s megadeal total to 63, topping the 2015 record, according to LSEG data on transactions since 1988.

The frenzy comes despite a sluggish start to the year after the US president’s “liberation day” tariffs sparked weeks of market volatility and deep uncertainty about interest rates and the global economic outlook.

“Companies are taking advantage of this window to pursue the larger transactions that they’ve long wanted to do and have been expected by the market,” said Ivan Farman, global co-head of mergers and acquisitions at Bank of America.

“When you see big deals being struck in your industry, you don’t want to be left out when the chess pieces move.”

Deals roared back in the second half of 2025 as CEOs pounced on once-in-a-generation transactions, including Union Pacific’s $85bn bid for Norfolk Southern, the $55bn Saudi-backed take-private of Electronic Arts, Anglo American’s $50bn merger with Teck and Kimberly-Clark $49bn takeover of Tylenol maker Kenvue.

Edward Lee, a corporate partner at Kirkland & Ellis, said CEOs and boards now had the “confidence and visibility” to chase “big strategic moves that they postponed for two years because of interest-rate uncertainty, inflation and the election”.

The greater visibility would allow deals that were previously hitting regulatory roadblocks to finally get done, Lee added.

The second half of the year deal blitz comes after Trump pulled back from a full-blown trade war with China and choked back some of his most aggressive tariffs, all while doubling down on M&A-friendly measures, including relaxing antitrust rules.

“There’s a feeling right now in the current regulatory environment that there’s a chance to do larger-scale transactions that you may not have the opportunity to do again,” said Krishna Veeraraghavan, co-head of Paul Weiss’s M&A group.

The animal spirits have spread across sectors. Bank M&A surged as deals were approved at the fastest pace in more than three decades, while Big Pharma roared back, acquiring biotech assets to restock their drug pipelines. A boom in artificial intelligence spurred a wave of tech and data centre transactions.

“We’re seeing increased activity not just in tech, driven by a tsunami of money going into AI infrastructure, but also in healthcare, industrials, financial and other sectors,” said Drago Rajkovic, global co-head of M&A at Citigroup.

“Why are there so many large deals? There has been a lot of pent-up demand, a favourable regulatory environment and healthy balance sheets,” he added.

But M&A has been stronger among larger companies than smaller ones, a sign that deal activity remains uneven.

“Small deals are often harder to get done as they’re less interesting to buyers because they don’t move the needle. Fundamentally, smaller deals have lower returns, so there’s a trend towards our clients focusing on large transactions,” said Andrew Woeber, global head of M&A at Barclays.

As financial traders milled around 26 floors up in a tower in the Canary Wharf district of London, there was little sign of nerves ahead of Rachel Reeves’s second budget – until the surprise accidental early release of the government’s official economic analysis started to move markets.

Headline numbers from the Office for Budget Responsibility (OBR) flashed through on banks of computer screens, followed shortly by the detailed analysis itself.

“Boom! There’s your 200-pager,” said Will Marsters, a sales trader at Saxo UK, a trading platform that hosted the Guardian for the announcement. The leak triggered a race across trading desks in the City of London to understand the implications of the leaked forecasts – and laughter at the hapless forecaster.

It was a chaotic start to the budget, but more important for financial investors and the Treasury was the reaction on currency and bond markets. The Labour government was desperate to avoid a repeat of the Liz Truss “mini-budget” debacle, when borrowing costs surged, eventually bringing about the downfall of the Conservative government.

The reaction on Wednesday was choppy, but not dramatic by the standards of the Truss government. The yield on the benchmark 10-year gilt – a measure of the cost of government borrowing – dropped quickly from 4.5% to about 4.42%. A few minutes later it was back up above 4.52%.

By the late afternoon yields had fallen back once more, to 4.4%. The declining borrowing cost over the day will likely be a relief for Reeves – and a sign that markets do not think lending money to the UK has become more risky.

“The tempered growth didn’t seem too optimistic, which eroded some of the risk premium,” said Marsters.

Neil Wilson, an investor strategist at Saxo UK, said: “There’s no great stinging surprise that has upset markets. That has allowed it to be a bit of a relief.”

However, he wondered about the credibility of the forecasts: governments often promise to tighten budgets in later years in order to make the sums add up. With elections expected around the same time, he said the prospect of welfare cuts or tax rises in four years’ time was remote.

“You’re saying we’re going to buy fiscal restraint by the end of the parliament,” Wilson said. “‘Don’t worry about welfare – we’ll sort it out’.”

The value of the pound also jumped in initially volatile trading after the OBR leak. It then fell as low as $1.3124, before recovering by late afternoon to $1.3229 – an increase of 0.5% for the day.

Mike Owen, another sales trader, said: “Everyone was fearing the worst, so the price action is, ‘Phew’. It’s such a minefield to try to get through it.”

Nov 26 (Reuters) – A federal judge dealt a setback to customers suing Burger King over advertising for its Whopper sandwiches, saying their claims were too disparate to justify certifying a nationwide class action.

The lawsuit by 19 customers in 13 U.S. states accused Burger King of misleadingly and materially inflating the size of nearly all menu items online and on in-store ordering boards.

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These included Whoppers whose burgers allegedly appeared to “overflow” the buns and be 35% larger than they are, with more than double the meat.

But in a decision on Tuesday, U.S. District Judge Roy Altman in Miami said the state consumer protection laws underlying the lawsuit had many differences. He also said individualized claims would predominate because the plaintiffs bought burgers in an “almost-infinite variety” of shapes and sizes.

“It may be that every single one of those burgers was smaller than every single menu-board item Burger King has ever produced. But that’s not the point,” Altman said. “Each putative class member will have seen a particular photo and received a specific burger.”

The judge also said Burger King’s prices have “undoubtedly waxed and waned” since April 1, 2018, the start of the proposed class period, and all class members would need to show when and where they bought burgers, and what they paid.

Lawyers for the plaintiffs did not immediately respond to requests for comment.

Burger King said it was satisfied with the decision. It repeated its May statement that the plaintiffs’ claims are false, and that “the flame-grilled beef patties portrayed in our advertising are the same patties used in the millions of burgers we serve to guests across the U.S.”

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Multiple operators made up the majority of pharmacy sales instructions in 2025, according to a report from pharmacy brokers Hutchings Consultants.

In its ‘England pharmacy market report 2025’, published on 25 November 2025, the pharmacy sales agency pointed out sales data showing that corporate and multiple operators made up 71% of all sales instructions in 2025 to date.

The agency described this as a “clear reversal of the 2024 landscape, when independent sellers held a comparable majority share”.

Independent pharmacy owners made up 19% of sales instructions in 2025, the report said, with “groups focused on divesting outlier branches” making up the remainder of the sales.

For sales, first-time buyers dominated demand, accounting for 76% of new registrations, followed by independent owners at 12%, investors at 8% and group owners, previous owners and multiples at 4%.

Expanding independent owners led completions at 44%, followed by first-time buyers at 29% and group owners at 27%.

“Hutchings has observed a modest downward trend in average pharmacy goodwill values achieved year to date compared with previous years,” the report said.

“This reflects a shift in market dynamics, as an increase in multiple and corporate disposal instructions has expanded the pool of available opportunities, in turn diluting buyer competition.

“Ongoing concerns surrounding business profitability and financial performance have also contributed to a cautious approach among buyers, echoing the sentiment and conditions seen in the sales market of the previous year.”

Pharmacy multiple Jhoots has sold off some of its branches this year, with Allied Pharmacies announcing it had acquired 60 Jhoots stores on 7 November 2025.

Gareth Jones, director of corporate affairs at the National Pharmacy Association, said that data showing “very large numbers of pharmacy owners are valuing or selling their businesses is clear evidence of the financial pressures in the market and the uncertainty regarding medicines supply”.

“These reports tell us little about the prices pharmacy businesses are fetching, nor their short- and medium-term financial stability,” he added.

“We hope that optimism about the growth in services is borne out in government policy and investment.”

A spokesperson for the Independent Pharmacies Association (IPA) commented: “We assume the sample size Hutchings are quoting relate to just them; therefore, a relatively small sample size.

“From what we have seen from IPA members, they can grow fairly quickly with multiple acquisitions in a short space of time.”

The Coin Laundry, the latest investigation from the International Consortium of Investigative Journalists, brought together journalists from more than 35 countries to expose dirty money flowing into the world’s largest cryptocurrency exchanges. From Canada to France, Uruguay, Malaysia and beyond, the investigation shed light on this growing shadow economy.

Reporting by ICIJ’s 37 media partners examined scams around the world and found a troubling global pattern: regulators are struggling to keep pace with evolving technology and the savvy criminals who exploit it.

ICIJ and its partners also explored a surge in services where criminals can covertly cash out huge sums of cryptocurrency without ever touching the mainstream banking system.

Here are some of the stories journalists uncovered as part of The Coin Laundry.

Canadian crypto-to-cash services

In Canada, a new way to launder money has emerged. Shopfronts where people can convert cryptocurrency into cash have been cropping up in urban centers across the country. These businesses offer exchange services, often without asking customers to disclose their identities or the origin of their funds.

ICIJ media partners CBC/Radio Canada, the Toronto Star and La Presse collaborated on an investigation into these crypto-to-cash operations. The three outlets conducted a test transaction at one of the businesses, Ukraine-based 001k.exchange, which offers services in several major cities in North America.

Using a Telegram account, an undercover Toronto Star journalist posed as a prospective 001k customer and organized a transaction of 2,000 USDT, a cryptocurrency called tether that’s pegged to the U.S. dollar, to see how the process worked. 001k then provided a cryptocurrency address, which the reporter transferred the USDT to.

To pick up her cash, the reporter entered a midtown Toronto storefront and requested the payout without being asked to show any kind of identification — a violation of Canadian anti-money laundering laws, according to the outlets. Instead, she was asked to share the serial number on a Canadian $5 bill, which would be used to verify which customer she was.

In a video of the handover, the Toronto Star journalist can be seen entering a business offering remittance services on a busy street in Canada’s largest city by population. After examining the serial number on the bill, the teller is shown handing over a stack of cash without checking ID or asking questions.

The remittance business told CBC/Radio Canada, the Toronto Star and La Presse the employee in the video was conducting “his own business under the table.” 001k did not respond to questions from the outlets.

Binance curbs cooperation in Europe

The Coin Laundry examined how law enforcement and regulators have often had to rely on the cooperation of major cryptocurrency trading platforms known as exchanges to trace criminal proceeds on their platforms.

In Belgium, ICIJ media partners De Tijd and Knack found that Binance, the world’s largest cryptocurrency exchange and a central subject of ICIJ’s reporting, has stopped cooperating with the Belgian police and judicial authorities in criminal investigations.

In order to identify and freeze illicit transactions on their platforms, exchanges are generally expected to collaborate with law enforcement and take action when requested. A 2023 Europol report that detailed certain exchanges’ level of cooperation with European law enforcement agencies found that Binance was one of the most willing, ICIJ’s partners found.

But since April, Binance’s cooperation has faltered, De Tijd and Knack reported. According to several law enforcement sources in Belgium and other members of the European Union, Binance has stopped responding to all requests from police, public prosecutors and investigating judges when data is sought related to suspicious accounts.

“Binance has always cooperated well with the Belgian police. But suddenly, at a certain point, it refused to cooperate with the police,” Kevin Wiliquet, a crypto specialist with the Belgian federal police in Brussels, told De Tijd and Knack. “That’s really quite recent.”

Binance decided to transfer its Belgian customers to its Polish division in 2023 following heightened scrutiny from the Belgian Financial Services and Markets Authority, the outlets reported. Since the spring, the crypto behemoth has spread its data across numerous international jurisdictions — including in the Seychelles, a well-known secrecy haven — complicating Belgian law enforcement’s requests for user data.

Belgian magistrates have argued that Binance’s blockchain is borderless, according to De Tijd and Knack, meaning that requests for assistance or access to data should not need to be sent abroad and that Belgian law applies regardless of jurisdiction. But according to Wiliquet, Binance has simply stopped complying with information requests in Belgium and other EU member states.

De Tijd and Knack found that Binance was not alone — other major exchanges were also creating barriers when requests come from European law enforcement, their reporting showed.

In a statement to De Tijd and Knack, Binance said it “regularly cooperates with law enforcement agencies globally, including in Belgium, to support investigations and combat financial crime.”

South America scams

In Ecuador and Colombia, ICIJ partner CONNECTAS, along with Vistazo and El Espectador, detailed a multimillion-dollar cryptocurrency investment scheme involving a former television actress, a Christian church and an allegedly fraudulent online business school that promoted easy money for investors. Instead, thousands of people were reportedly saddled with debt.

The ADN Business School promised to help participants earn money quickly with questionable business tactics such as foreign exchange trading, sports betting and buying up cryptocurrency tokens, according to the outlets.

CONNECTAS and Vistazo determined that $176 million in at least 36 different cryptocurrencies was lost before prosecutors could freeze and seize them. The prosecutor’s office in Ecuador confirmed that it had successfully traced those losses to Binance, where the accused masterminds of the ADN Business School scheme had registered several wallets.

In the end, the alleged criminals moved the funds before prosecutors could take action, and only $500 worth of cryptocurrency has so far been recovered for the victims. Officials told the outlets that two major obstacles allowed the funds to slip out of reach: the lack of an institutional wallet address and the inability to move quickly to seize assets

In Uruguay, ICIJ media partner Búsqueda examined a separate criminal complaint against a former rugby player-turned-accused crypto fraudster who fled the country after allegedly stealing millions of dollars from wealthy investors.

The player, Gonzalo Campomar, and his alleged accomplice, Martín Cajal, were both charged with orchestrating the investment scheme that touted lucrative returns — 2% a month — from cryptocurrency investments, according to Búsqueda. Camponar left Uruguay in October 2024, shortly after the first legal complaints  from disgruntled investors started to appear.

Búsquedas could not determine the total number of victims or the amount of money Campomar and Cajal allegedly stole but at least one law firm in a suburb of Montevideo reportedly received complaints from victims who ultimately did not pursue legal action due to the murky origin of some of their lost funds.

Cajal did not respond to Búsqueda’s request for comment. Campomar declined to comment. He told the news outlet that, when ready, he will give his version of events in court.

The latest inflation figures showed a jump in the growth of average prices from 3.6% to 3.8%. But they also indicate just how much our economy is caught up in the ramifications of Russia’s illegal invasion of Ukraine, which sent gas prices higher – and with it our electricity prices.

The October consumer price index figures were a turning point for data in Australia. It marks the change of the official CPI figures going from quarterly to monthly. This is pretty much the biggest data shift since the labour force figures back in 1978 did the same switch from quarterly to monthly.

The move is a good one, given most nations in the OECD measure prices monthly. It gives the Reserve Bank and the government more regular information.

For a number of years, the Australian Bureau of Statistics had been testing measuring inflation monthly, but it left out a few things while it worked out how to count everything. As a result, the latest figures are slightly different from the old monthly figures:

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On the old measure, inflation was slightly lower than the new official measure.

This is also reflected with the “trimmed mean” measure of underlying inflation. While the old monthly figures suggested underlying inflation was below 3%, the new official figures have it at 3.3%

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The underlying inflation measure will probably take on more importance now that the official measure has moved to a monthly survey. The overall CPI figures will now be rather more noisy than they were when they involved an average of three months.

You can see how this affects things when you look at the monthly growth since April 2024 (which is how far back the official monthly data goes). Rather oddly, despite the annual inflation figure rising in October, in October itself inflation did not rise at all:

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This weirdness is even more stark when we look at the biggest drivers of inflation:

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Electricity was the biggest driver of inflation over the past year, but in October electricity prices fell 10.2%.

This confusion is due to the interaction of electricity rebates and inflation.

In July 2023, the Albanese government introduced rebates to protect against the increase in prices due to the Russian invasion of Ukraine. In July 2024, the states began to get involved as well. And October last year saw the largest impact of the federal and state government rebates on electricity prices:

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But these rebates did not last, and over the past 12 months they have begun to be unwound – and so prices began to rise. Then in August they were extended across a number of areas – and so electricity prices fell again.

But they remain well above where they were in October last year.

Importantly, inflation is the growth of prices from one month to the next, and from one month to the same month the following year. So purely because last October was the month where the energy rebates had the biggest impact, the annual growth in electricity prices since then looks massive.

Were the government rebates not put in place, electricity costs would be about 31% higher now, but the growth (or inflation) of electricity costs would be lower.

But then the question is: why were these rebates needed, and what the heck does it have to do with Putin invading Ukraine?

The problem for Australia is that since the opening of the Gladstone LNG terminal, gas prices on the eastern seaboard have been linked with the world price of gas. Because Russia is a major producer of gas, its invasion of Ukraine and subsequent sanctions of Russian gas and other trade sent world gas prices soaring – doubling from January 2022 to September that year.

Gas is a significant generator of Australia’s electricity, but it is also among the most expensive. However, the way the national energy market operates is that the most expensive source for electricity determines the price at any point in time.

When renewables are able to supply 100% of our electricity, they will determine the cost and prices will be much lower. But because gas often sets the prices (because gas-generated electricity is needed to meet demand), that means there is a very strong link between gas prices and electricity:

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Without the energy rebates, electricity prices would have followed gas prices up, and the hit to households would have been much greater.

On the other side of the coin, the boom in gas prices has led to gas companies making out like bandits.

The value of gas exports from Australia is nearly four times what it was a decade ago. Alas this massive windfall gain for gas companies has not led to a windfall in revenue of the government in the form of the petroleum resource rent tax – if anything, revenue has fallen:

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These latest inflation figures will give few people any joy – not the RBA, nor the government, nor any of us looking at our bills. But they will continue to give comfort to energy and gas producers who know their windfall profits will remain largely untouched by Australia’s tax system.