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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Main Authors: Agustín Fernández-Cisnal, Beatriz Silla, José María Ramón, Ernesto Valero, Sergio García-Blas, Julio Núñez, Vicent Bodí, Juan Sanchis, Gema Miñana
Format: Article
Language:English
Published: Permanyer 2023-08-01
Series:REC: Interventional Cardiology (English Ed.)
Subjects:
Online Access:https://recintervcardiol.org/en/index.php?option=com_content&view=article&id=1058
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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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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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