Abstract Introduction Vasectomy is a widely performed procedure for male sterilization, with an estimated 33 million procedures conducted annually worldwide. Although vasectomy is generally safe and associated with minimal complications, concerns over procedural pain and anxiety can deter patients from pursuing the procedure. To address these concerns, innovations such as no-needle and no-scalpel techniques have been adopted to minimize pain during vasectomy. However, anticipated pain and anxiety remain significant barriers for patients. Therefore, optimizing patient comfort during procedures performed under local anesthesia is crucial for improving outcomes and satisfaction. Virtual reality (VR) devices have emerged as a promising non-pharmacological intervention for pain modulation in various medical fields. VR technology has demonstrated pain reduction and anxiety alleviation in pediatric burn therapy, physical therapy, dental procedures, and more. The adult urologic community has also embraced VR, with positive results observed in surveillance cystoscopy and office-based prostate biopsy procedures. However, limited research exists on the use of VR headsets during vasectomy, with only one previous non-randomized trial reporting high patient satisfaction but no improvement in pain or anxiety. In this ongoing single-center, randomized, open-label clinical trial, we present interim data evaluating the effectiveness of the SmileyScope VR device in reducing anxiety and pain during in-office vasectomy performed with local anesthesia. Objective The primary objective of this study is to evaluate the efficacy of virtual reality (VR) devices in alleviating peri-procedure anxiety and pain during in-office vasectomy performed with local anesthesia. The secondary goal of this study is to compare the effectiveness of interactive VR, enabling patient control of the experience, with static VR, which does not provide patient control. Methods The study enrolled patients who were scheduled for in-office vasectomy with a single urologist. The patients were randomly assigned to one of three groups: the control group receiving standard in-office vasectomy without a VR headset, the static VR intervention group, or the interactive VR intervention group. The primary outcome measures included patient-reported pain and anxiety levels before and after the procedure, along with heart rate measurements recorded using a wearable device. Results Interim analysis of this ongoing study includes data from a total of 58 men. 20 men were in the control group, 19 in the static VR arm, and 19 in the interactive VR arm. There was no observed difference in subjective pain scores or heart rate variability during the procedure. However, patients who wore a VR headset reported a significantly lower level of pre-procedure anxiety (P = 0.0700). Conclusions Anticipation of periprocedural pain and anxiety are barriers to vasectomy utilization. Initial results from our ongoing randomized clinical trial indicate that the utilization of virtual reality is feasible, safe, and effective in reducing pre-procedure anxiety in patients undergoing vasectomy. Disclosure No.
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