L'Utilizzo Della realtà Virtuale Mediante l'Impiego Del Visore Ottico Nel Paziente Oncologico Sottoposto al Posizionamento di PICC e PICC-PORT

Virtual reality (VR) has increasingly been explored in medical settings as a non-pharmacological intervention for the management of pain and anxiety associated with invasive procedures. By providing immersive and interactive environments, VR is thought to modulate both sensory and emotional components of pain through mechanisms involving focused attention, cognitive engagement, and altered perception, which share similarities with hypnosis-based approaches. Evidence from previous studies, initially conducted mainly in paediatric populations and more recently extended to adults, suggests that VR may effectively reduce procedural anxiety and pain without increasing procedural duration or clinical workload.

Oncology patients undergoing the placement of vascular access devices, such as peripherally inserted central catheters (PICC) and PICC-PORTs, frequently experience procedural distress, including anxiety and discomfort, related to the invasive nature of the intervention. Procedural anxiety may negatively influence patient experience, cooperation, and overall tolerance of the procedure, potentially increasing the need for pharmacological anxiolytic or analgesic support. Identifying effective, safe, and easily applicable non-pharmacological strategies to reduce distress during these procedures represents a relevant clinical goal in oncology care.

The present study aims to evaluate the effectiveness of virtual reality delivered via a head-mounted display in reducing patient-reported anxiety and pain in adult oncology patients undergoing PICC or PICC-PORT insertion.

This study is designed as a prospective, interventional, randomised controlled trial with a 1:1 allocation ratio using an independent, certified web-based randomisation service. Approximately 120 patients will be enrolled at a single centre, the Istituto Oncologico Veneto (IRCCS), and randomly assigned to one of two study arms. Participants allocated to the intervention arm will receive VR in addition to the standard of care (VR + SOC) throughout the vascular access placement procedure, while participants in the control arm will undergo the standard procedure alone (SOC).

The VR intervention will be delivered using HypnoVR, a software-based medical device classified as Class I, non-sterile, and compliant with Regulation (EU) 2017/745 on Medical Devices. The intervention will be administered via a head-mounted display with audiovisual content designed to promote relaxation, focused attention, and emotional regulation during the procedure.

The primary outcome of this study is a composite patient-reported procedural experience endpoint, assessed immediately after the procedure. The primary analytical component of this composite endpoint is procedural anxiety, measured using a 10-point Visual Analogue Scale for Anxiety (VAS-A). The main statistical analysis will compare changes in VAS-A scores between the intervention group and the control group.

The additional dimensions of the composite endpoint, patient-reported comfort, satisfaction and procedural tolerability, are collected concurrently and are not aggregated into a single score. These dimensions are analysed separately and interpreted jointly with procedural anxiety in order to provide an overall assessment of the patient's procedural experience.

Secondary outcomes include: 1) procedural pain, assessed using a 10-point Visual Analogue Scale (VAS); 2) physiological parameters, including heart rate and arterial blood pressure; 3) procedural characteristics, such as procedure duration and number of device insertion attempts; 4) qualitative assessment of patients' perceptions and lived experiences of the procedure, analysed using Van Kaam's phenomenological method18.

Data collection will include both quantitative and qualitative measures within a mixed-methods framework. Quantitative data will be analysed using descriptive and inferential statistical methods to assess differences between study groups, while qualitative data derived from semi-structured interviews will be analysed using the Van Kaam phenomenological method to explore patients' lived experiences. The aim of this study is to evaluate the effect of an immersive virtual reality intervention on the overall procedural experience of adult oncology patients undergoing PICC and PICC-PORT placement, with patient experience conceived as a primary dimension of quality of care.