Clinical Research Directory

Using Virtual Reality During PICC and PICC-PORT Placement in Cancer Patients

Sponsor: Istituto Oncologico Veneto IRCCS

Summary

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 a random number generator within REDCap. A total of 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 measure is the reduction of anxiety levels at the end of the procedure, assessed using the validated Visual Analogue Scale for Anxiety (VAS-A). Secondary outcomes include patient-reported pain, qualitative assessment of procedural comfort, and perceived ease of procedural management as reported by healthcare staff. 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 study aims to provide evidence on the role of virtual reality as a supportive, non-pharmacological option for anxiety and pain management during vascular access placement in oncology patients.

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

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