Exploring customised virtual environments in patients with cognitive decline and responsive behaviours: protocol for a proof-of-concept and feasibility study in a long-term care facility (iEMBRACE).

INTRODUCTION: 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. METHODS AND ANALYSIS: 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. ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: NCT06693193.