The global rise in the population aged over 65 has led to a corresponding increase in cognitive impairment diagnoses, with dementia as a predominant condition characterised by diverse aetiopathogenetic profiles. Behavioural and psychological symptoms of dementia (BPSD) encompass a range of psychiatric, behavioural and cognitive symptoms associated with cognitive impairment. BPSD significantly affects patients, caregivers and healthcare providers, often necessitating interventions like sedatives or physical restraints that may worsen patient outcomes. Emerging evidence underscores the need for innovative, non-pharmacological interventions to manage BPSD effectively.

The current study intends to investigate the feasibility and acceptability of customised, immersive virtual reality environments (iVRe) to reduce responsive behaviours among individuals with dementia. Building on prior findings demonstrating virtual reality (VR) potential in reducing anxiety and fostering positive emotional states, this pilot study assesses the feasibility, safety and user engagement of customised iVRe interventions.

A longitudinal, mixed-methods design will be employed, enrolling 20 elderly participants with varying levels of cognitive impairment from the APSP ‘Margherita Grazioli’ long-term care facility in Trento. Participants undergo three VR exposure sessions featuring tailored environments adjusted in real-time for visual and auditory preferences. Data collection integrates standardised self-report questionnaires, observational tools and clinical records. Measures include the Functional Assessment Staging Tool, Neuropsychiatric Inventory and Cohen-Mansfield Agitation Inventory, as well as tools assessing pain, anxiety and emotional states before, during and after VR sessions.

The study protocol has been approved by the Comitato Etico Territoriale della Provincia Autonoma di Trento per le Sperimentazioni Cliniche, Azienda Provinciale per i Servizi Sanitari—Trento, Italy (Rep. Int. 12090, 15 May 2025). All participants or their legal representatives will provide written informed consent prior to enrolment. Deidentified data will be securely stored on institutional servers at the Fondazione Bruno Kessler and the APSP ‘Margherita Grazioli’, curated in compliance with the General Data Protection Regulation, and retained for 3 years after study completion. Any data shared externally will be provided in fully anonymised form, and only for scientific purposes, subject to prior ethical and legal approval. Study findings will be disseminated through peer-reviewed publications, conference presentations and executive summaries shared with participating institutions and stakeholders.

NCT06693193.

Infant feeding practices in the first 2 years of life are linked to long-term weight trajectories. Despite the importance of obesity prevention interventions, there are no randomised controlled trials (RCTs) evaluating early childhood education and care (ECEC) and primary caregiver-targeted interventions on child weight and feeding outcomes.

To assess the efficacy of an 18-month digital health intervention (Tiny Bites) delivered to ECEC services and primary caregivers of children aged 4 to ≤12 months on child age-adjusted and sex-adjusted body mass index-for-age z-score (zBMI) relative to usual care control in the Hunter New England (HNE) region of New South Wales, Australia.

This type 1 hybrid cluster RCT will include up to 60 ECEC services and 540 children/caregiver dyads. The intervention supports ECEC services and caregivers to deliver recommended responsive feeding practices to infants. ECEC services will receive access to an online assessment platform, training and resources, and implementation support. Primary caregivers will receive text messages, monthly e-newsletters, online links and direct communication from ECEC services. We will assess the impact on child zBMI at 18-month follow-up. Secondary outcomes include duration of consuming any breastmilk, child diet and caregiver responsive feeding practices. We will also assess ECEC policy and practice implementation related to targeted feeding practices, programme cost effectiveness, adverse effects and engagement with the programme (ECECs and caregivers). For the primary outcome, between-group differences will be assessed for paired data using two-level hierarchical linear regression models.

Ethics approval has been provided by HNE Human Research Ethics Committee (HREC) (2023/ETH01158), Deakin University (2024-202) and University of Newcastle HREC (R-2024-0039). Trial results will be submitted for publication in peer-reviewed journals, presented at scientific conferences locally and internationally and to relevant practice stakeholders.

ACTRN12624000576527.

Effective haemorrhage control is crucial in cases of limb trauma involving arterial injury, such as shark attacks, to prevent potentially fatal outcomes. International first aid consensus recommends the use of arterial tourniquets (proprietary or makeshift) as a primary treatment for life-threatening external bleeding. Manual pressure applied directly over a major artery proximal to the injury, such as inguinal fist compression (IFC), is more accessible in a first-aid situation, but is currently not recommended due to limited evidence. The purpose of this study is to determine whether the application of IFC is superior to commercial windlass tourniquets (CWTs) in reducing blood flow in the femoral artery when performed by untrained bystanders.

Stopping Haemorrhage by Application of Randomised Compression or Tourniquet (SHARC-2) is a superiority, assessor-blinded, cross-over, randomised controlled trial conducted with healthy untrained adult volunteers in non-clinical settings. Participants will be rotated as providers and recipients of both IFC and CWT, with providers randomised to the order that they perform the techniques. Providers will be exposed to an educational infographic before applying that technique to a recipient behind a drop sheet. A sonographer, blinded to the technique, will measure the peak systolic velocity of blood flow in the superficial femoral artery using Doppler ultrasound at baseline and then during application of each technique for 5 min. The mean percentage reduction in peak systolic velocity will be compared between IFC and CWT groups.

Ethics approval for this study was granted by the Bond University Human Research Ethics Committee (BUHREC JF01036) on 23 January 2023. All participants will be provided with written informed consent prior to enrolment and the trial will involve healthy adult volunteers. To minimise risk, preintervention screening, sonographic assessment and postintervention follow-up will be implemented with adverse events monitored and reported in accordance with HREC guidelines. Results will be disseminated through peer-reviewed journals, academic conferences, local resuscitation forums and public health education initiatives. A lay summary will also be shared with relevant community groups and via social media platforms to enhance public accessibility.

ACTRN12624001054505.

Women with severe mental illness (SMI) face barriers to cervical cancer screening, leading to lower participation and poorer outcomes. This research aimed to develop and test an informed-choice tool to help women with SMI make informed decisions about screening attendance.

The tool was developed using a realist review of physical health interventions and a systematic review of informed-choice tools for people with SMI. A mixed-methods approach informed its development. Usability and acceptability were assessed through semistructured interviews and the think-aloud method with service users (n=18), clinicians (n=16) and key informants. A preliminary proof-of-concept (n=25) evaluated the impact on decisional conflict—the uncertainty around making value-sensitive choices.

Conducted in two National Health Service (NHS) Mental Health Trusts (urban and rural). Participants included women with SMI accessing secondary mental healthcare, clinicians and service user groups. A key informants’ group guided clinical content.

A cervical screening informed-choice leaflet and an accompanying video.

The tool was usable and acceptable, especially for women overdue or never screened. It may reduce decisional conflict and increase screening uptake, potentially improving survival. An National Institute for Health and Care Research (NIHR)-funded feasibility trial (Improving uptake of cervical screening in people with severe mental illness (OPTMISE)) is underway. The current UK government guidance on Support for people who find it hard to attend cervical screening due to having a mental health condition or having experienced trauma or abuse is based on this research.

Future research may involve further assessments of the real-world impact of the tool and its adaptation to other health-related decisions.