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 pr...
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2023-08-01
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author | Agustín Fernández-Cisnal Beatriz Silla José María Ramón Ernesto Valero Sergio García-Blas Julio Núñez Vicent Bodí Juan Sanchis Gema Miñana |
author_facet | Agustín Fernández-Cisnal Beatriz Silla José María Ramón Ernesto Valero Sergio García-Blas Julio Núñez Vicent Bodí Juan Sanchis Gema Miñana |
author_sort | Agustín Fernández-Cisnal |
collection | DOAJ |
description | 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. Diseño del ensayo registrado en ClinicalTrials.gov (identificador: NCT05458999). |
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last_indexed | 2024-03-12T21:58:56Z |
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series | REC: Interventional Cardiology (English Ed.) |
spelling | doaj.art-516be09f22db401698b01b3178cd261a2023-07-25T10:54:51ZengPermanyerREC: Interventional Cardiology (English Ed.)2604-73222023-08-015320320910.24875/RECICE.M23000370Efficacy of virtual reality reducing anxiety during CTO revascularization: the ReViCTO trial designAgustín Fernández-Cisnal0Beatriz Silla1José María Ramón2Ernesto Valero3Sergio García-Blas4Julio Núñez5Vicent Bodí6Juan Sanchis7Gema Miñana8Unidad de Hemodinámica y Cardiología Intervencionista, Servicio de Cardiología, Hospital Clínico Universitario de València, Instituto de Investigación Sanitaria (INCLIVA), Universidad de Valencia, Valencia, Spain. Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV), SpainUnidad de Hemodinámica y Cardiología Intervencionista, Servicio de Cardiología, Hospital Clínico Universitario de València, Instituto de Investigación Sanitaria (INCLIVA), Universidad de Valencia, Valencia, SpainUnidad de Hemodinámica y Cardiología Intervencionista, Servicio de Cardiología, Hospital Clínico Universitario de València, Instituto de Investigación Sanitaria (INCLIVA), Universidad de Valencia, Valencia, SpainUnidad de Hemodinámica y Cardiología Intervencionista, Servicio de Cardiología, Hospital Clínico Universitario de València, Instituto de Investigación Sanitaria (INCLIVA), Universidad de Valencia, Valencia, Spain. Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV), SpainUnidad de Hemodinámica y Cardiología Intervencionista, Servicio de Cardiología, Hospital Clínico Universitario de València, Instituto de Investigación Sanitaria (INCLIVA), Universidad de Valencia, Valencia, Spain. Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV), SpainUnidad de Hemodinámica y Cardiología Intervencionista, Servicio de Cardiología, Hospital Clínico Universitario de València, Instituto de Investigación Sanitaria (INCLIVA), Universidad de Valencia, Valencia, Spain. Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV), SpainUnidad de Hemodinámica y Cardiología Intervencionista, Servicio de Cardiología, Hospital Clínico Universitario de València, Instituto de Investigación Sanitaria (INCLIVA), Universidad de Valencia, Valencia, Spain. Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV), SpainUnidad de Hemodinámica y Cardiología Intervencionista, Servicio de Cardiología, Hospital Clínico Universitario de València, Instituto de Investigación Sanitaria (INCLIVA), Universidad de Valencia, Valencia, Spain. Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV), SpainUnidad de Hemodinámica y Cardiología Intervencionista, Servicio de Cardiología, Hospital Clínico Universitario de València, Instituto de Investigación Sanitaria (INCLIVA), Universidad de Valencia, Valencia, Spain. Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV), SpainABSTRACT 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. Diseño del ensayo registrado en ClinicalTrials.gov (identificador: NCT05458999).https://recintervcardiol.org/en/index.php?option=com_content&view=article&id=1058Chronic total coronary occlusion Virtual reality Anxiety |
spellingShingle | Agustín Fernández-Cisnal Beatriz Silla José María Ramón Ernesto Valero Sergio García-Blas Julio Núñez Vicent Bodí Juan Sanchis Gema Miñana Efficacy of virtual reality reducing anxiety during CTO revascularization: the ReViCTO trial design REC: Interventional Cardiology (English Ed.) Chronic total coronary occlusion Virtual reality Anxiety |
title | Efficacy of virtual reality reducing anxiety during CTO revascularization: the ReViCTO trial design |
title_full | Efficacy of virtual reality reducing anxiety during CTO revascularization: the ReViCTO trial design |
title_fullStr | Efficacy of virtual reality reducing anxiety during CTO revascularization: the ReViCTO trial design |
title_full_unstemmed | Efficacy of virtual reality reducing anxiety during CTO revascularization: the ReViCTO trial design |
title_short | Efficacy of virtual reality reducing anxiety during CTO revascularization: the ReViCTO trial design |
title_sort | efficacy of virtual reality reducing anxiety during cto revascularization the revicto trial design |
topic | Chronic total coronary occlusion Virtual reality Anxiety |
url | https://recintervcardiol.org/en/index.php?option=com_content&view=article&id=1058 |
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