Abstract
BACKGROUND: In the context of outpatient hysteroscopy (OPH), performing a single procedure integrating the operative and diagnostic part is known as "See & Treat hysteroscopy". The virtual reality (VR) technology provides an immersive virtual environment that can provide a non-invasive analgesic. To date, there is limited evidence regarding its use in the OPH setting. OBJECTIVES: To evaluate the feasibility and effectiveness of VR technology for pain and anxiety management in OPH. METHODS: Unblinded, prospective, randomised controlled trial, conducted at the Hysteroscopy Unit of the University of Naples "Federico II" between May and July 2024. Women aged 18-70 years, indicated for OPH, were randomised into a control group (standard OPH care) and an intervention group (OPH care with the addition of a VR headset). MAIN OUTCOME MEASURES: Pain and anxiety were assessed through subjective measures: numerical rating scale (NRS) scores before and after the procedure, and objective measures: heart and respiratory rate pre- and during the procedure. Satisfaction, time, and success rates were also evaluated. RESULTS: Overall, 116 women were enrolled. The VR group compared to the control group reported significantly lower mean standard deviation NRS scores for pain [3.9 (2.7) vs. 5.4 (3.0); mean difference 1.5, 95% confidence interval (CI) 0.4 to 2.5] and anxiety [3.2 (2.1) vs. 4.8 (2.8); mean difference 1.6, 95% CI 0.7 to 2.5] respectively. Regarding satisfaction, 96.5% of the VR group would use the headset again, whereas 3.5% requested its removal. All women in the control group desired a distraction. No serious adverse events were reported. CONCLUSIONS: VR technology proved feasible and effective for pain and anxiety management in OPH, particularly during operative procedures. WHAT IS NEW? Its use can support the implementation of the See & Treat philosophy.