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      Eficacia de la realidad virtual en la reducción de la ansiedad en la revascularización de las OTC: diseño del ensayo ReViCTO Translated title: Efficacy of virtual reality reducing anxiety during CTO revascularization: the ReViCTO trial design

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          Abstract

          RESUMEN Introducción y objetivos: Las intervenciones coronarias percutáneas (ICP) sobre oclusiones totales crónicas (OTC) son procedimientos largos en los que muchos pacientes sufren ansiedad y dolor. La realidad virtual ha demostrado reducir el dolor y la ansiedad en muchos procedimientos médicos. Nuestro objetivo es demostrar que el uso de la realidad virtual durante la ICP de OTC reduce la ansiedad y el dolor en comparación con la práctica convencional. Métodos: Ensayo clínico aleatorizado, controlado, abierto y de superioridad con 2 grupos paralelos en el que 58 pacientes con una ICP de OTC programada serán aleatorizados 1:1 al uso de realidad virtual frente al tratamiento convencional. La administración de fármacos ansiolíticos será a criterio del operador principal y en función del grado de ansiedad o dolor percibido. El resto de las acciones para el tratamiento de la ansiedad serán idénticas en ambos grupos. El objetivo primario será el nivel máximo de ansiedad percibido por el paciente. Los objetivos secundarios serán el nivel de dolor percibido por el paciente, la necesidad de tratamiento farmacológico ansiolítico, la dosis de fármaco administrada y la satisfacción con la realidad virtual. Resultados: Los resultados de este estudio añadirán conocimientos importantes sobre la utilidad de la realidad virtual en la reducción de la ansiedad en los procedimientos de ICP de OTC. Conclusiones: El ensayo ReViCTO es el primer ensayo clínico aleatorizado que utiliza la realidad virtual durante la ICP en OTC. Sus resultados mostrarán la utilidad de esta tecnología para reducir la ansiedad y el dolor en esta intervención. Diseño del ensayo registrado en ClinicalTrials.gov (identificador: NCT05458999).

          Translated abstract

          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).

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          Most cited references43

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          SPIRIT 2013 statement: defining standard protocol items for clinical trials.

          The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.
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            The effectiveness of virtual reality distraction for pain reduction: a systematic review.

            Virtual reality technology enables people to become immersed in a computer-simulated, three-dimensional environment. This article provides a comprehensive review of controlled research on the effectiveness of virtual reality (VR) distraction for reducing pain. To be included in the review, studies were required to use a between-subjects or mixed model design in which VR distraction was compared with a control condition or an alternative intervention in relieving pain. An exhaustive search identified 11 studies satisfying these criteria. VR distraction was shown to be effective for reducing experimental pain, as well as the discomfort associated with burn injury care. Studies of needle-related pain provided less consistent findings. Use of more sophisticated virtual reality technology capable of fully immersing the individual in a virtual environment was associated with greater relief. Overall, controlled research suggests that VR distraction may be a useful tool for clinicians who work with a variety of pain problems. Copyright © 2010 Elsevier Ltd. All rights reserved.
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              Assessment of chronic pain. I. Aspects of the reliability and validity of the visual analogue scale.

              The visual analogue scale (VAS) is a simple and frequently used method for the assessment of variations in intensity of pain. In clinical practice the percentage of pain relief, assessed by VAS, is often considered as a measure of the efficacy of treatment. However, as illustrated in the present study, the validity of VAS estimates performed by patients with chronic pain may be unsatisfactory. Two types of VAS, an absolute and a comparative scale, were compared with respect to factors influencing the reliability and validity of pain estimates. As shown in this study the absolute type of VAS seems to be less sensitive to bias than the comparative one and is therefore preferable for general clinical use. Moreover, the patients appear to differ considerably in their ability to use the VAS reliably. When assessing efficacy of treatment attention should therefore be paid to several complementary indices of pain relief as well as to the individual's tendency to bias his estimates.
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                Author and article information

                Journal
                recic
                REC: Interventional Cardiology
                REC Interv Cardiol ES
                Sociedad Española de Cardiología (Madrid, Madrid, Spain )
                2604-7306
                2604-7276
                September 2023
                : 5
                : 3
                : 203-209
                Affiliations
                [2] Madrid orgnameCentro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV) orgdiv1Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV) España
                [1] Valencia orgnameUniversidad de Valencia orgdiv1Hospital Clínico Universitario de València, Instituto de Investigación Sanitaria (INCLIVA) orgdiv2Unidad de Hemodinámica y Cardiología Intervencionista, Servicio de Cardiología España
                Article
                S2604-73062023000300007 S2604-7306(23)00500300007
                10.24875/recic.m23000370
                2f0a4ff7-6dd9-4c15-a1f6-515dad00d25e

                This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

                History
                : 03 February 2023
                : 17 January 2023
                Page count
                Figures: 0, Tables: 0, Equations: 0, References: 43, Pages: 7
                Product

                SciELO Spain

                Categories
                Artículos originales

                Ansiedad,Chronic total coronary occlusion,Virtual reality,Anxiety,Oclusión total crónica,Realidad virtual

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