An Immersive Virtual Reality Intervention for Preoperative Anxiety and Distress Among Adults Undergoing Oncological Surgery: Protocol for a 3-Phase Development and Feasibility Trial (Preprint)

Abstract

Preoperative state anxiety (PSA) is distress and anxiety directly associated to perioperative events. PSA is associated with negative postoperative outcomes like longer hospital length of stay, increased pain, higher opioid use, and higher rates of re-hospitalization. Psychological prehabilitation such as education, exposure to hospital environments, and relaxation, has been shown to mitigate PSA, however there are limited skilled personnel in clinical practice. Immersive virtual reality (VR) has the potential for greater accessibility and enhanced integration into an immersive and interactive virtual experience. VR is rarely used in the preoperative setting, but similar forms of stress inoculation training involving exposure to stressful events have improved subjects’ psychological preparation in contexts such as military deployment. This study seeks to develop and investigate a targeted PSA intervention in patients undergoing an oncologic surgical procedure using a single preoperative exposure to a VR program.

The primary objectives are (i) to develop a novel VR program for patients undergoing oncological surgery with general anesthesia, (ii) to assess the feasibility and acceptability of a single exposure to this intervention in the preoperative period, (iii) to assess the feasibility and acceptability of outcomes measures of perioperative anxiety and distress and (iv) to use these results to refine the VR content and outcome measures for a larger trial of the VR exposure. A secondary objective is to preliminarily assess the clinical utility of the intervention for PSA.

This study comprises 3 phases. Phase 1 (completed) involved the development of a VR prototype targeting PSA, using multidisciplinary iterative input. Phase 2 (ongoing) involves examining the feasibility aspects of the VR intervention. This randomized feasibility trial involves assessing the novel VR preoperative intervention compared to a control VR condition and treatment as usual group among breast cancer surgery patients. Phase 3 will involve refining of the prototype based on feasibility findings and input from people with lived experience for a future clinical trial, employing focus groups with participants from Phase 2.

This study was funded in March 2019. Phase 1 was completed in April 2020. Phase 2 is currently underway and data collection will be completed in January 2024. Focus groups will also be completed in January 2024. Both the feasibility study and focus groups will contribute to further refinement of the initial VR prototype (Phase 3) in Winter of 2023/2024.

The findings from this initiative will contribute to the limited body of research examining feasible and broadly accessible interventions for PSA. Knowledge gained from this research will contribute to the final development of a novel VR intervention to be tested in a large population of oncological patients prior to surgery in a randomized clinical trial.

ClinicalTrials.gov NCT04544618 (Phase 2 only)