Evaluation of Virtual Reality for Reducing Opioid Use After Cardiac and Thoracic Surgery
Trial Parameters
Brief Summary
This clinical trial aims to evaluate the efficacy of virtual reality (VR) as an adjunctive therapeutic method to reduce opioid consumption during the postoperative period of cardiac and thoracic surgeries. It is a single-center, prospective, randomized trial that will include 60 patients aged 16 to 40 undergoing surgeries such as valve replacements, pulmonary decortication, thoracic sympathectomies, and video-assisted thoracic procedures. Patients will be randomized into three groups: Group 1: Standard anesthesia protocol combined with interactive VR therapy using games like Fruit Ninja 2, Beat Saber, and Oculus First Contact, as well as passive contemplation of immersive virtual environments (Blue Planet, Wander). Group 2: Standard anesthesia protocol combined with VR therapy focusing solely on passive imagery, such as immersive 360° videos available on YouTube VR. Group 3 (Control): Standard anesthesia protocol without any VR intervention. The VR intervention will occur in three daily sessions lasting 30-45 minutes each, over the first five postoperative days or until hospital discharge, whichever comes first. Training in VR equipment usage and full supervision by the study team will be provided throughout all sessions. Primary Objective: The primary goal is to reduce total opioid consumption, measured through medical prescriptions and patient-controlled analgesia (PCA) pump usage. Pain control will be assessed using the Visual Analogue Scale (VAS). Secondary Objectives: Evaluate the incidence of postoperative nausea and vomiting (PONV). Measure the duration of mechanical and non-invasive ventilation. Assess the length of stay in the ICU and the total hospital stay. Record the occurrence of paralytic ileus. Evaluate patient satisfaction. Assess cognitive status using the Mini-Mental State Examination (MMSE). Rationale: Postoperative pain following cardiac and thoracic surgeries is commonly treated with opioids, which are associated with adverse effects such as respiratory depression, nausea, vomiting, constipation, and risk of dependency. Virtual reality offers an innovative approach to pain management by creating immersive environments that serve as cognitive distractions. This immersive distraction modulates pain perception, reduces anxiety, and enhances overall well-being. Prior studies have shown that VR can effectively reduce pain perception and improve patient satisfaction, supporting its potential as a non-pharmacological adjunct in various clinical contexts. Methods: Participants will undergo standardized surgical and anesthetic protocols at the Instituto do Coração (InCor) of the Hospital das Clínicas at the University of São Paulo. Clinical and demographic data will be collected, including opioid consumption, VAS pain scores, ventilatory parameters, and other relevant recovery indicators. Statistical analyses will include descriptive statistics, univariate comparisons, and multivariate logistic regression to identify significant associations between the interventions and outcomes. Analyses will be performed using SPSS, with statistical significance set at p \< 0.05. Anticipated Outcomes: The study anticipates that VR will significantly reduce postoperative opioid consumption, enhance pain control, and improve patient satisfaction. Additionally, patients exposed to VR may experience shorter hospital stays, reduced side effects, and better overall recovery metrics. If proven effective, VR could serve as a scalable, cost-effective, and safe complement to traditional postoperative pain management strategies, especially in populations where minimizing opioid use is a clinical priority. Ethical Considerations:
Eligibility Criteria
Inclusion Criteria: * Patients undergoing elective cardiac or thoracic surgeries at the Heart Institute (InCor) of the Hospital das Clínicas of the University of São Paulo. * Eligible thoracic surgeries include: pulmonary decortication, thoracic sympathectomy, video-assisted thoracoscopic surgery (VATS), pulmonary biopsy, and pectus excavatum repair using the Nuss procedure. * Patients aged between 16 and 40 years. * Preserved cognitive function, indicated by a Mini-Mental State Examination (MMSE) score of ≥ 25. Exclusion Criteria: * Visual impairments. * Cognitive impairment (MMSE ≤ 24). * Severe upper limb motor limitations. * Claustrophobia. * Spatial disorientation. * Motion sickness or vestibular disorders. * Infectious or contagious diseases.