Efficacy of virtual reality reducing anxiety during CTO revascularization: The ReViCTO trial design

Abstract

Introduction and objectives: Percutaneous coronary interventions (PCI) of chronic total occlusions (CTO) are long procedures where many patients suffer moderate-To-high level anxiety and pain. Virtual reality (VR) has proven capable of reducing procedural pain and anxiety in many medical procedures. The objective of this study is to demonstrate that the use of VR during CTO PCI reduces anxiety and pain compared to conventional routine clinical practice. Methods: Randomized, controlled, open-label, superiority trial clinical trial with 2 parallel arms including 58 patients with a scheduled CTO PCI randomized on a 1:1 ratio to VR during the procedure or conventional management. In both arms, the administration of anxiolytic drugs will be left to the lead operator's discretion and based on the degree of anxiety o pain perceived. The remaining actions for the management of pre-and perioperative anxiety will be identical in both arms. The primary endpoint will be the maximum level of anxiety perceived by the patient. Secondary endpoints will be the level of patient-perceived pain, the need for intraoperative anxiolytic drug therapy, dose of drug administered, and satisfaction with the VR goggles. Results: The results of this study will add significant knowledge on the utility of VR regarding anxiety reduction in CTO PCIs. Conclusions: The ReViCTO trial is the first randomized clinical trial to use VR during a PCI CTO. Its results will show the utility of this technology to reduce anxiety and pain in PCIs performed on CTOs. Trial design registered at ClinicalTrials.gov (Identifier: NCT05458999).