A Virtual Reality based intervention for surgical patients: study protocol of a randomized controlled trial
Abstract Background: Pain after surgery is normal, and treatments, including both pharmacological and psychological components, are fundamental for a proper postoperative care. While several trials have investigated the analgesia effect of traditional non-pharmacological treatments, such Cognitive Behaviors Therapies for pain after surgery, the newer ways of delivering psychological interventions are paucity investigated. The aim of this randomized controlled trial (RCT) is to determine if delivering the psychological content through Virtual Reality (VR) along with the standard pharmacological treatment return better pain outcomes then standard care in adults patients following surgery. Methods: This is a protocol of a parallel RCT conducted in one community hospital. In the following day after surgery, adults (18 to 65 years) will be randomly assigned to either (1) standard treatment after surgery (control group) or (2) VR based intervention along with standard treatment. A minimum of 27 patients is intended to be recruited in each group. For estimating the intensity of pain, both self-report and physiological measures will be used. Repeated measures of pain outcomes will be taken before and after the intervention. Moreover, for allowing in-depth investigation on the effect of VR environments, the estimates of pain intensity will be complemented with measures of the adverse effects, level of immersion, and level of presence in the VR environment. Discussion: It has already been established that VR can improve the outcomes of pain treatment at burn patients. Successful implementation in post-operative settings has the potential to change the recovery trajectory of individuals with surgical interventions. However, the best mode of implementation in terms of efficacy, acceptability, and side effects is still unclear. The present trial will provide guidance for pain interventions to be implemented on large scale and will provide scientific support in discussing treatment options for individual patients. Trial registration status: ClinicalTrials, NCT03776344. Retrospectively registered in December 14, 2018, https://clinicaltrials.gov/ct2/show/NCT03776344.