Diarrhoeal illnesses remain a leading cause of morbidity and mortality worldwide. Understanding when and where individuals seek healthcare is essential for accurately assessing disease burden and improving access to appropriate care. We conducted a meta-synthesis of qualitative research examining barriers and facilitators to care-seeking for diarrhoeal illness among individuals and caregivers of children.

We systematically reviewed qualitative studies examining the motivations for seeking care for diarrhoeal illness and conducted a thematic analysis to synthesise findings across studies.

PubMed, Embase, Web of Science and Global Index Medicus were searched through 3 September 2024.

We included qualitative studies that used interviews and/or focus group discussions to examine care-seeking decisions for diarrhoeal illness.

Two independent reviewers assessed studies for eligibility, extracted study information and coded factors influencing care-seeking decisions. The two researchers then independently created thematic trees based on patterns in the coded data and, through discussion with the full research team, synthesised findings into a thematic framework.

In total, 47 studies met our inclusion criteria, 36 of which focused on caregiver decision-making for children with diarrhoea in low- and middle-income countries. Our meta-synthesis identified several key factors that influenced whether and when individuals sought care. Sociocultural norms, including locally held beliefs about disease causation, were frequently cited as influencing decisions to seek or delay formal care. Additional barriers included long travel distances to health facilities, transportation costs, limited trust in healthcare providers, negative feelings and inconsistent availability of care. Conversely, episodes perceived as severe were more likely to prompt care-seeking outside the home.

These findings highlight the importance of contextually grounded interventions that improve physical and financial access to care, foster trust in healthcare providers through consistent and effective service delivery and strengthen community engagement around recognising signs of severe illness and the potential benefits of timely treatment. They also underscore the need for future studies to define diarrhoea in locally relevant terms and to clearly define sources of care-seeking, as variation in these definitions can limit our full understanding of who is affected and how individuals respond to illness.

The literature examining direct-to-consumer (DTC) commercial virtual care has expanded rapidly over the past decade. Our objective was to synthesise the nature and range of evidence on DTC commercial virtual care.

Scoping review.

MEDLINE ALL, EMBASE Classic+Embase, CINAHL, HealthSTAR, PsycINFO, CENTRAL and grey literature sources.

We included original research studies published in English or French between 1 January 2016 and 30 April 2025 that assessed DTC commercial virtual care in all contexts and in all populations.

Screening titles and abstracts, and full-text manuscripts, and extracting data was done in duplicate. We analysed quantitative data using descriptive statistics and reported findings in tables. We provided a narrative summary of textual data.

After excluding duplicates, we identified 8055 studies for title and abstract screening; 691 articles for full-text screening; and 103 studies meeting our inclusion criteria. 32 studies (31.1%) reported financial ties to the virtual care industry. 67 (65.0%) studies were conducted in the USA. Studies were largely quantitative (87/103 (84.5%)) or mixed methods (8/103 (7.8%)) studies and used cross-sectional (85/95 (89.5%)) designs. Most quantitative studies were descriptive, reporting on quality of care, health outcomes, platform characteristics and patient views, with only 24 of the 95 quantitative studies (25.3%) including a control or comparison group. 18 of these 24 studies (75.0%) compared the quality of care, costs and/or utilisation to other models of care and reported variable findings. The rest compared patient characteristics. Few studies assessed clinician perspectives or addressed privacy-related ethical concerns.

Despite a large number of studies assessing DTC commercial virtual care, we have little insight into impacts on quality of care, health outcomes, health system utilisation and privacy-related ethical concerns. The financial ties with industry suggest that there may be bias in the body of research literature.

To characterise long-term trajectory of recovery in individuals with long covid.

Prospective cohort.

Single-centre, specialist post-COVID service (London, UK).

Individuals aged ≥18 years with long covid (hospitalised and non-hospitalised) from April 2020 to March 2024.

Routine, prospectively collected data on symptoms, quality of life (including Fatigue Assessment Scale (FAS) and EuroQol 5 Dimensions (EQ-5D), return to work status and healthcare utilisation (investigations, outpatient and emergency attendances). The primary outcome was recovery by self-reported >75% of ‘best health’ (EQ-5D Visual Analogue Scale) and was assessed using Cox proportional hazards regression models over 4 years. Linked National Health Service England registry data provided secondary care healthcare utilisation and expenditure.

We included 3590 individuals (63.3% female, 73.5% non-hospitalised, median age 50.0 years, 71.9% with ≥2 doses of COVID-19 vaccination), who were followed up for a median of 136 (0–346) days since first assessment and 502 (251–825) days since symptom onset. At first assessment, 33.2% of employed individuals were unable to work. Dominant symptoms were fatigue (78.7%), breathlessness (68.1%) and brain fog (53.5%). 33.4% of individuals recovered to >75% of best health prior to clinic discharge (recovery occurred median 202 (94–468) days from symptom onset). Vaccinated individuals were more likely to recover faster (pre: HR 2.93 (2.00–4.28) and post: HR 1.34 (1.05–1.71) COVID-19 infection), whereas recovery hazard was inversely associated with FAS (HR 0.37 (0.33–0.42)), myalgia (HR 0.59 (0.45–0.76)) and dysautonomic symptoms (HR 0.46 (0.34–0.62)). There was high secondary care healthcare utilisation (both emergency and outpatient care). Annual inpatient and outpatient expenditure was significantly lower in hospitalised individuals while under the service. When compared with the prereferral period, emergency department attendances were reduced in non-hospitalised patients with long covid, but outpatient costs increased.

In the largest long covid cohort from a single specialist post-COVID service to date, only one-third of individuals under follow-up achieved satisfactory recovery. Fatigue severity and COVID-19 vaccination at presentation, even after initial COVID-19 infection, was associated with long covid recovery. Ongoing service provision for this and other post-viral conditions is necessary to support care, progress treatment options and provide capacity for future pandemic preparedness. Research and clinical services should emphasise these factors as the strongest predictors of non-recovery.

To develop and validate a concise, physician-specific quality-of-life scale (Afya MedQol) Index, and to examine sociodemographic and occupational correlates of physician well-being in Brazil.

Nation-wide, cross-sectional, web-based survey employing split-sample psychometric validation: exploratory factor analysis, confirmatory factor analysis (CFA), multidimensional graded-response item-response theory calibration and post-stratification weighting to the 2025 Brazilian medical demographic census.

Physicians practising in all five Brazilian macro-regions and 27 state medical councils (2 July 2024–6 August 2024).

A total of 2005 fully responding physicians (56% women; mean age 38.5±12.6 years).

Domain scores—F1: Quality of Life, F2: Institutional Support, F3: Perceived Stress—and a Fisher-information-weighted global score. Convergent validity with WHOQOL-Bref; subgroup differences (Cohen’s d, partial ²).

CFA supported a three-factor, 13-item solution (Comparative Fit Index=0.987; Root Mean Square Error of Approximation=0.050) with strict invariance across sex and graduation-year quartiles. Item-response modelling showed marginal reliability =0.82. Convergent validity with WHOQOL-Bref domains was strong (r=0.55–0.73). Weighted mean (95% CI) scores were: Global 67.2 (66.5–67.9), F1 69.5 (68.9–70.2), F2 64.1 (63.4–64.8) and F3 62.5 (61.8–63.2).Women scored higher on Perceived Stress (F3) than men by 5.6 points (weighted mean difference 5.6, 95% CI 4.0 to 7.2; Cohen’s d 0.28). Physicians working ≥60 hours/week scored higher on Perceived Stress than those working ≤44 hours/week by 8.8 points (weighted mean difference 8.8, 95% CI 6.7 to 10.9; Cohen’s d 0.40). Well-being increased with income up to ~BRL 25 000 per month and plateaued thereafter.

Afya MedQoL Index is a psychometrically robust, 13-item instrument capturing personal, organisational and stress dimensions of physician well-being. Perceived Stress—shaped by workload, institutional climate and gender—was the most discriminative domain, while additional income beyond an upper-middle-class threshold conferred negligible benefit. Findings support policies aimed at capping duty hours, fostering ‘just-culture’ environments and expanding flexible work models.

The work of receptionists in general practice is evolving rapidly and becoming more complex due to a number of changes within primary and community care services, such as increased digitalisation. In under-served areas, these changes have been further complicated by under-resourcing and workforce challenges around staff recruitment and retention. The National Health Service (NHS) 10-year health plan is set to accelerate further significant changes. There is limited understanding about how and why these changes and workforce challenges are impacting and will impact the future work of receptionists in general practice in under-served areas.

This realist review will build on an existing programme theory related to general practitioner workforce sustainability. The review will examine what works, for whom, how and under what circumstances for receptionist work in general practice, in under-served areas. For example, how influences such as the expectations of patients (in under-served communities), poor staffing or limited career progression. Key stakeholders, including public contributors and individuals from general practice settings, will inform the realist review.

The review will be conducted using existing secondary and grey literature sources. The search strategy comprises five electronic databases: Medline, Embase, PsycINFO, CINAHL and Web of Science Core Collection (SCIE, SSCI, AHCI) with a date limit of 2015 applied to the search. The review will follow Pawson’s five steps: (1) shaping the scope of the review; (2) searching for evidence; (3) document selection and appraisal; (4) data extraction and (5) data synthesis. The findings will be reported in accordance with the Realist and Meta-narrative Evidence Synthesis Evolving Standards.

Ethical approval is not needed for secondary analysis. The findings of this review will contribute to ongoing work as part of our ‘Workforce Voices’ programme of research. They will be disseminated to policymakers, commissioners, providers of health and social care and primary care and community healthcare teams through peer-reviewed publications, members of the public, conference presentations, social media and recommendations.

Depressive symptoms are common in the growing geriatric surgical population and are associated with important patient-centred surgical outcomes, including postoperative delirium, discharge to postacute care facility and decline in functional status. Few interventions have been developed to address depressive symptoms in the perioperative setting.

We designed a feasibility and acceptability study of a nine-session problem-solving therapy (PST) telehealth perioperative intervention aimed at reducing postoperative functional decline and depressive symptoms among at-risk older adults undergoing major surgical procedures. Acceptability will be evaluated using a patient-centred five-question survey, assessing participant satisfaction and perceived usefulness of the perioperative intervention. A feasibility assessment will rely on objective measures including ease of participant recruitment, frequency and timing of delivery of intervention sessions and retention of participants throughout the duration of the intervention. With respect to the efficacy of the proposed PST intervention, the primary outcome of interest is postoperative functional status, as measured by the WHO Disability Assessment Schedule 2.0 at the 6-month postoperative time point. The secondary outcome of interest is the degree of depressive symptoms as assessed by the Patient Health Questionnaire-9 at both 3 months and 6 months postoperatively. The broader goals of this study include: (1) assessing the feasibility of implementing a PST perioperative intervention for older surgical patients at risk of postoperative functional decline, (2) demonstrating the acceptability of the PST intervention and (3) assessing the preliminary impact of the PST intervention on postoperative functional status and depressive symptoms.

The study received ethical approval from the University of California San Francisco Institutional Review Board. Results of this study will be published in peer-reviewed scientific journals with further dissemination at local institutional meetings and professional conferences.

NCT06174701.

To estimate the workload of the nursing team and its associated factors during the intraoperative period for adult patients undergoing elective and urgent/emergency surgeries.

Cross-sectional study.

Surgical units of two hospitals in Brazil.

We prospectively assessed the workload using the National Aeronautics and Space Administration – Task Load Index (NASA-TLX) score and analysed the electronic medical records of patients who agreed to participate in the study, from November 2023 to February 2024. We included data from 116 nursing professionals and 402 surgeries.

Among the procedures analysed, the median raw NASA-TLX score in cardiac surgery was significantly higher (60.8; IQR 40.0–72.5 points) compared with the others. We observed that in the generalised linear model procedures over minutes presented around 25% greater workload compared with 120 min surgeries (1.252; 95% CI 1.1018 to 1.549) and patients classified as American Society of Anesthesiologists (ASA) physical status classification (ASA) III and IV exhibited approximately 24% higher workload compared with those classified as ASA I (1.241; 95% CI 1.003 to 1.550).

Surgical length and ASA physical status influence the workload. Thus, we suggest that surgical unit leaders give special attention to long-term surgical procedures and patient severity on perioperative workload when dimensioning nursing staff.

Inhaled anaesthetics can be used in mechanically ventilated critically ill patients to provide sedation. This approach to sedation potentially improves patient and health system outcomes, but further supportive evidence is needed. The objective of the SAVE-ICU clinical trial is to compare the effectiveness of inhaled versus intravenous sedation in ventilated adults with acute hypoxaemic respiratory failure.

SAVE-ICU is a multicentre, open-label, pragmatic, randomised controlled trial conducted in 15 intensive care units (ICUs) in Canada and the USA. Eligible patients include mechanically ventilated and sedated adults with acute hypoxemic respiratory failure from COVID-19 or non-COVID causes with PaO₂/F_IO₂ ratio 12 hour). A hierarchy of outcomes was identified at the time of trial design, as the trial was launched during the COVID-19 pandemic when study drug shortages, staffing challenges and healthcare system pressures were prevalent and there was a requirement for rapid evidence generation and implementation on this topic. The primary outcome and highest in the hierarchy is hospital mortality (requiring 758 participants). Secondary and lower hierarchical outcomes are ventilator-free days at day 30 (200 patients), quality of life at 3 months (144 participants) and ICU-free days at day 30 (128 participants). Additional secondary outcomes include median daily oxygenation at day 3 (PaO₂/F_IO₂ ratio), need for adjunctive acute respiratory distress syndrome therapies (prone positioning, inhaled nitric oxide, paralysis with a neuromuscular blocking agent and extracorporeal membrane oxygenation) during ICU stay, days alive and free from delirium and coma at day 14, hospital-free days at day 60 and disability score at 3 months and 12 months after enrolment.

The protocol was approved by all hospital ethics committees and by Health Canada. Informed consent will be obtained from substitute decision makers or deferred consent (as permitted by site ethics board). Trial findings will be shared at the end of the study using peer-review publications, conference presentations and social media as part of the trial knowledge translation plan.

NCT04415060.

Photobiomodulation therapy (PBMT), particularly when combined with a static magnetic field (PBMT-sMF), is a promising non-pharmacological approach for managing musculoskeletal disorders. However, high-quality evidence for its efficacy in lateral epicondylitis remains limited.

The study aims to investigate the effectiveness of PBMT-sMF vs placebo in reducing pain, improving function and modulating inflammatory markers in individuals with lateral epicondylitis.

Multicentre, randomised, triple-blinded, placebo-controlled trial.

Three outpatient physiotherapy clinics in Brazil.

50 adults (18–50 years) with unilateral lateral epicondylitis and baseline pain ≥50 on the visual analogue scale (VAS).

Participants received either active PBMT-sMF (n=25) or placebo (n=25), 2 times per week for 3 weeks. PBMT-sMF involved multi-wavelength irradiation at 4 epicondyle sites (60 s; 27.1 J/site). The placebo group underwent the same procedure without active irradiation.

The primary outcome was degree of pain rating (VAS). Secondary outcomes included forearm disability (Patient-Rated Tennis Elbow Evaluation, PRTEE), grip strength, serum tumour necrosis factor-alpha (TNF-α) levels and treatment satisfaction. Assessments were conducted at baseline, post-treatment (3 weeks) and at 4-week follow-up.

PBMT-sMF yielded a higher responder rate (defined as the proportion of participants achieving at least a 30% reduction in pain intensity relative to baseline) than placebo (72% vs 40%, p=0.045), with a clinically and statistically significant between-group difference. Compared with placebo, the PBMT-sMF group showed significantly greater reductions in pain intensity both at the end of treatment (51.4±19.8 vs 36.9±22.6; p=0.0223) and at follow-up (37.4±24.1 vs 20.3±21.2; p=0.0049). TNF-α levels also decreased significantly in the PBMT-sMF group compared with placebo at both time points (p

PBMT-sMF significantly reduced pain intensity and TNF-α levels, suggesting an anti-inflammatory mechanism. Although functional outcomes were not improved, PBMT-sMF may be a valuable short-term, non-invasive option for lateral epicondylitis pain management.

NCT04829734 on ClinicalTrials.gov

Approximately, 20 million older adults undergo major elective surgery annually, yet less than 10% engage in advance care planning (ACP). This is a critical missed opportunity to optimally engage in patient-aligned medical decisions and communications in the perioperative setting. The PREPARE ACP programme (easy-to-read advance directives (ADs) and a patient-directed, online ACP programme) has been shown to increase ACP documentation and patient and clinician empowerment to discuss ACP. Yet, a gap remains in extending PREPARE’s use to surgical populations. We hypothesise that by delivering PREPARE in a patient-facing electronic health record (EHR) centric presurgery workflow for older adults, supported by automated patient reminders and outreach from a healthcare navigator (HCN), we can enable patients and/or surgical teams to engage in ACP discussions.

This is a three-site, single-blinded, pragmatic randomised trial comparing increasing intensity of ACP-focused, patient-facing EHR messaging and HCN support. The outreach occurs prior to a new presurgical clinic visit. We will enrol 6000 patients (2000 each site) aged 65 and older and randomise them equally to the following study arms: (Arm 1) ACP-related cover letter and PREPARE URL information sent via patient portal and postal mail (includes cover letter, AD and PREPARE pamphlet); (Arm 2) Arm 1 plus reminder message via text or MyChart message and (Arm 3) Arm 2 plus HCN outreach and support. The primary outcome is clinically meaningful ACP documentation in the EHR (ie, surrogate designation, documented discussions and ADs) within 6 months of the new surgical visit. The rate of ACP documentation will be compared between treatment groups using generalised estimating equations. Secondary outcomes include a validated four-item ACP engagement survey, administered 2 weeks after the presurgical visit and 6 months later. All analyses will follow the intention-to-treat principle and recent Consolidated Standards of Reporting Trials guidelines.

The study will be conducted according to the Declaration of Helsinki, Protection of Human Volunteers (21 Code of Federal Regulations (CFR) 50), Institutional Review Boards (21 CFR 56) and Obligations of Clinical Investigators (21 CFR 312). The protocol and consent form were reviewed and approved by Advarra, an National Insitutes of Health (NIH)-approved, commercial, centralised Institutional Review Board (IRB). The IRB/Independent Ethics Committee of each participating centre reviewed and approved the protocol and consent and obtained reliance agreements with Advarra prior to study initiation. The study is guided by input from patient and clinical advisory boards and a data safety monitoring board. The results of the study will be disseminated to both academic and community stakeholders, complying with all applicable privacy laws.

ClinicalTrials.gov ID: NCT06090552.

Advarra Pro 00070994.

23-38948.

Protocol Date: 24 October 2024. Protocol Version: 4.

Perineal trauma is one of the most common complications of childbirth, impacting approximately 9 out of 10 women who undergo a vaginal delivery. Perineal trauma is a public health issue leading to increased maternal morbidity and decreased quality of life. Although race is being studied as a potential risk factor and predictor of perineal trauma, other contributing factors like racism and social determinants of health have not been adequately studied in the same context. We set out to synthesise the available peer-reviewed evidence evaluating the prognostic association between race and perineal trauma.

This systematic review and meta-analysis adheres to the PRISMA-P (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols) and PROGRESS (Prognosis Research Strategy) guidelines and is registered with PROSPERO. The review explores the association between racial status (non-Hispanic white vs non-white) and perineal birth trauma using the PECOTS (Population, Intervention/Exposure, Comparator, Outcome, Timing and Setting) framework. We will search PubMed, CINAHL, Web of Science and Embase. Peer-reviewed observational studies will be included. Data extraction and screening will be done in duplicate. Analyses will use random-effects models in R, reporting both unadjusted and adjusted risk differences. Risk of bias will be assessed using ROBINS-I (Risk of Bias in Non-randomised Studies of Interventions). Heterogeneity and certainty of evidence will be evaluated using I² and GRADE (Grading of Recommendations Assessment, Development and Evaluation), respectively.

This is a systematic review based on previously published data, and therefore ethical approval is not required. The findings of this review will be disseminated through publication in a peer-reviewed journal and presented at academic conferences.

CRD42025590093.

Relational continuity of care (RCC) refers to the sustained therapeutic relationship between a patient and a clinician, which fosters trust, enhances communication and facilitates the accumulation of knowledge about the patient. RCC is associated with enhanced patient outcomes, reduced hospital admissions, lower mortality rates, decreased healthcare costs and improved patient experience. Despite these benefits, reorganisations within the NHS and workforce challenges have led to an increased reliance on multidisciplinary and part-time working, resulting in fragmented care and a decline in RCC. Our study aims to explore who needs RCC, under what circumstances, to what extent and why, with the goal of informing optimal implementation strategies.

We will conduct a realist review to develop an evidence-based programme theory explaining the mechanisms underlying RCC, the populations that benefit most, the contextual factors influencing RCC and effective care models. Following Pawson’s five iterative stages, we will: (1) Locate existing theories, (2) Search for relevant evidence, (3) Select appropriate articles, (4) Extract and organise data and (5) Synthesise findings to draw conclusions. A stakeholder advisory group, comprising policymakers, healthcare professionals, public contributors and patients, will be engaged throughout the process. We will adhere to Realist And Meta-narrative Evidence Synthesis: Evolving Standards (RAMESES) for realist reviews to ensure methodological rigor.

Our findings will inform practical, evidence-based recommendations for optimising RCC within general practice. Outputs will include peer-reviewed publications, conference presentations, plain English summaries, social media infographics, a short video and end-of-study events. Collaborations with stakeholders and public involvement will ensure both accessibility and impact. Ethical approval is not required for this review.

Cardiovascular (CV) disease is the leading cause of morbidity and mortality globally. Low-density lipoprotein cholesterol (LDL-C) is an important modifiable risk factor of major adverse cardiovascular events. Patients without prior myocardial infarction (MI) or stroke but with established risk factors and elevated LDL-C may benefit from intensive lipid-lowering therapy (LLT); however, the size and potential healthcare burden of this population globally are not known. The benefits of evolocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor, in these patients, are currently being studied in the phase 3 Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke (VESALIUS-CV) trial. To characterise the high-risk pre–CV-event (VESALIUS-CV–like) individuals in the real world, an observational study is being conducted across multiple countries.

This retrospective cohort study will use a common protocol and an analytical common data model approach to characterise VESALIUS-CV–like individuals in the real world across different geographical regions and healthcare settings. The study period will be from 2010 to 2022, subject to data availability in study sites. Patients aged 50 years and older at high risk of CV disease but without prior MI or stroke will be included in this study. VESALIUS-CV–like individuals are defined through a combination of the following: (1) one diagnosis of coronary artery disease, cerebrovascular disease, peripheral artery disease or diabetes with microvascular complications or chronic insulin use; (2) an elevated LDL-C measurement and (3) other high-risk factors. The objectives of this study are to estimate the prevalence of VESALIUS-CV–like individuals, describe their characteristics and care pathways and estimate their incidence rates of CV events and healthcare costs. The prevalence of VESALIUS-CV–like individuals will be expressed as annual prevalence; patient characteristics at index date will be presented using summary statistics; care pathways will be summarised as LLT prescription across time; and the incidence of defined CV events will be expressed as events per person-years as well as at certain time periods. Healthcare costs will be presented as CV-related costs in different time periods.

Approvals of the study protocol were obtained from relevant local ethics and regulatory frameworks for each participating database. The results of the study will be submitted to peer-reviewed scientific publications and presented at scientific conferences.

Procedure-related pain should be minimised to prevent psychological trauma and the potential negative consequences on body physiology. Dressing changes in paediatric patients with burn injuries are frequently performed with analgesics alone where sedation is not indicated, especially in minor and superficial burns. It is hypothesised that distraction methods can be used in addition to pain alleviating medication to reduce the experience of pain in these patients.

With this research project, we aim to assess the effectiveness of a simple, inexpensive, non-electronic distraction method, a kaleidoscope, to reduce acute pain experienced in paediatric patients undergoing dressing changes in the outpatient clinic.

A randomised controlled trial will be performed at the Ngwelezana Tertiary Hospital, Empangeni, South Africa. Paediatric patients between the ages of 5 years and 12 years with minor and superficial partial thickness burn injuries who require dressing changes in the outpatient clinic, without sedation, will be randomised into two groups with a 1:1 allocation ratio. Fixed randomisation will be performed by a computer random number generator. The control group will receive standard practice of care which concerns a dressing change without any distraction methods, and the intervention group will receive distraction by use of a kaleidoscope as an additional method for potential pain alleviation. Patients in both groups will receive paracetamol or non-steroidal anti-inflammatory drugs when indicated according to hospital protocol. The primary outcome will be the change in pain score from pre-procedural to pain score during the dressing change and will be analysed with a linear regression analysis. Additionally, subanalyses will be performed to evaluate potentially modifying factors on the treatment effect. This will also be evaluated with a linear regression analysis and correlated with caregiver and healthcare worker observational pain scores. Participants and assessors are not blinded to group assignment due to the nature of the intervention. To achieve a power of 80% and a level of significance of 5% for detecting at least a 1-point difference in change in pain scores between the intervention and control group, a sample size of 50 patients in each group is required.

This study evaluates a non-invasive adjunct to reduce pain in children who undergo a painful procedure. Ethical approval has been granted from the University of Kwazulu-Natal’s biomedical research and ethics committee and the ethics and research committee of Ngwelezana Tertiary Hospital prior to recruitment (ref no. BREC/00005194/2023). Written informed consent will be acquired from all study participants’ caregivers. Study findings will be presented orally to staff at the paediatric burn unit of Ngwelezana Tertiary Hospital (study location). The research methodology and results will be presented at scientific conferences and will be submitted for publication in a peer-reviewed journal.

NCT06591195.