Design and Protocol of a Randomised Controlled Trial Evaluating Virtual Reality to Improve Patient Experience During...

Background/Objectives: The placement of central venous access devices, including peripherally inserted central catheters (PICCs) and PICC-PORTs, is a routine procedure in oncology care. Usually associated with limited physical pain, these procedures may nevertheless generate significant anxiety and negatively influence the overall procedural experience. Virtual reality (VR) has emerged as a non-pharmacological intervention capable of modulating attentional and emotional responses during medical procedures; however, evidence in adult oncology patients undergoing vascular access placement remains scarce. The aim of this study is to evaluate the effect of VR on an oncological patient's overall procedural experience. Methods: This manuscript outlines the design and methodology of a prospective, single-centre randomised controlled trial. Adult oncology patients scheduled for PICC/PICC-PORT placement are randomised to receive standard care alone or standard care combined with an immersive VR intervention delivered via a head-mounted display during the procedure under pragmatic, real-world clinical conditions. The primary outcome is a composite patient-reported procedural experience endpoint, assessed through a non-aggregated framework encompassing procedural anxiety, comfort, satisfaction and procedural tolerability. Procedural anxiety constitutes the main quantitative driver; the remaining domains are analysed as individual component dimensions and interpreted jointly to contextualise the overall experience. Secondary outcomes include procedural pain, physiological parameters and procedural characteristics. A mixed-methods approach integrates quantitative assessment with qualitative phenomenological analysis. Results: The study is expected to provide methodological and clinical insight into the role of immersive VR in improving procedural experience and support future multicentre trials. Conclusions: This trial will contribute to the expanding field of digital and immersive health technologies by evaluating VR as a patient-centred adjunct intervention in oncological procedural care using a predefined patient-reported experience-based primary endpoint. The protocol has been submitted to ClinicalTrials.gov with the registration number NCT07384741.