About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Visual impairments.
Cognitive impairment (MMSE ≤ 24).
Severe upper limb motor limitations.
Claustrophobia.
Trial design
Parallel
Treatments tested in this trial
Interactive Virtual Reality
DevicePatients will utilize the Meta Quest 2 headset to engage in interactive applications requiring motor and cognitive tasks, such as Fruit Ninja 2 and Beat Saber, along with passive immersive software like Youtube VR. This dual approach combined with the institutional anesthesia protocol aims to maximize cognitive distraction. The intervention consists of three daily sessions of 30 to 45 minutes for five days postoperatively.
Passive Virtual Reality
DevicePatients in the Passive VR arm will receive standard anesthesia protocol combined with passive Virtual Reality (VR) therapy. This involves the use of a VR headset to watch immersive 360-degree videos, such as tranquil natural landscapes or underwater scenes, designed to promote relaxation and reduce anxiety. The VR sessions do not require active participation, allowing patients to passively observe calming environments. The intervention will be administered for 3 sessions per day, lasting 30-45 minutes each, over 5 consecutive postoperative days.
Treatment groups
Trial outcomes
Primary outcomes
Reduction in Opioid Consumption
Measured by the total dose of opioids administered postoperatively, converted to Morphine Milligram Equivalents (MME), over the first 5 days.
Secondary outcomes
Occurrence of Nausea and Vomiting
Frequency of postoperative nausea and vomiting episodes
Length of ICU Stay
Number of days spent in the ICU
Length of Hospital Stay
Number of days hospitalized
Length of Mechanical Ventilation
Hours of mechanical ventilation
Sponsors and contacts
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Filomena R B G Galas
Lead sponsor
Instituto do Coracao
Sponsor institution