Use of immersive virtual reality for stress reduction during botulinum toxin injection for spasticity (RVTOX): a study protocol of a randomised control trial

Abstract

Introduction Botulinum toxin injection is a common way to help reduce spasticity in the body caused by central neurological damage such as cerebral stroke, multiple sclerosis or traumatic brain injury. The pain felt during the injection causes most patients to experience significant stress for further injections, the level of which is variable between patients.Immersive virtual reality is a digital technique that simulates the three-dimensional spatial and sound environment around a person said to be immersed in this virtualised world. The effectiveness of virtual reality comes from the intensity of this multisensory immersion, known as the feeling of presence (ie, subjective experience of being in one place or one environment, even when you are physically in another one).Only one research article in paediatrics has shown that immersive reality technique has a positive impact on the level of pain and agitation suffered during botulinum toxin injections. The purpose of this study is therefore to evaluate with sufficient assurance the following research hypothesis: virtual reality can help adults cope with the stress and pain of botulinum toxin treatment injection.Methods and analysis The research hypothesis will be tested using a randomised stepped-wedge method versus a non-invasive technique (headset with virtual reality session) to its control (headset with no image nor audio).The design leads to considering the injection as a statistical unit as all participants will undergo the standard condition, the control technique and virtual reality technique.Ethics and dissemination Patients will be fully and fairly informed in terms of their understanding of the objectives and constraints of the study and the possible risks involved. They will also be entitled to refuse the study and/or withdraw, and this refusal will have no impact on their follow-up as part of their pathology. Dissemination of the results of this study will be through peer-reviewed publications, and national and international conferences.Ethics were approved by the Comité de Protection des Personnes Nord-Ouest in January 2022.Trial registration number NCT05364203.