Clinical Trial

Evaluation of Virtual Reality for Reducing Opioid Use After Cardiac and Thoracic Surgery

Study acronym: VR-USP
Recruiting
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Record status
This record was last updated April 15, 2026 (before its estimated May 15, 2026 completion). Its status may not reflect the trial's current state.
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. Conducted at InCor/HCFMUSP, this single-center, prospective, randomized trial will include 60 patients aged 16 to 40 undergoing procedures such as valve replacements, pulmonary decortication, and video-assisted thoracic surgeries. Patients will be randomized into three groups. The Interactive VR group receives standard anesthesia protocol combined with interactive VR therapy using games and immersive environments. The Passive VR group receives standard protocol combined with passive 360-degree immersive videos. The Control group receives standard anesthesia protocol without VR intervention. The intervention occurs in three daily sessions lasting 30-45 minutes each over the first five postoperative days or until hospital discharge. The primary objective is to measure the reduction in total opioid consumption through medical prescriptions and patient-controlled analgesia (PCA) pump usage. Secondary objectives include pain intensity assessed by the Visual Analogue Scale (VAS), incidence of postoperative nausea and vomiting (PONV), duration of mechanical and non-invasive ventilation, length of stay in the ICU and hospital, occurrence of paralytic ileus, patient satisfaction, and cognitive status using the Mini-Mental State Examination (MMSE). Opioids are standard for postoperative pain but are associated with adverse effects like respiratory depression. VR offers an innovative approach by creating immersive environments that serve as cognitive distractions to modulate pain perception and reduce anxiety. The study anticipates that VR will enhance pain control and improve recovery metrics, serving as a safe and scalable complement to traditional postoperative management.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-07-03.
Trial Details
NCT Number NCT07063394
Lead Sponsor Filomena R B G Galas
Conditions Heart Surgery, Thoracic Surgery, Opioid, Virtual Reality, Pain
Enrollment 60 participants
Start Date 2024-12-10
Primary Completion 2026-05-15 (estimated)
Study Completion 2027-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-15