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Evaluation of the Efficacy of Virtual Reality as a Therapeutic Method to Reduce Opioid Consumption in Postoperative Cardiac and Thoracic Surgery

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 40
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Brazil
Incor - Heart Institute - University of Sao Paulo
RECRUITING
São Paulo
Contact Information
Primary
Filomena Regina B Galas, PhD
filomenagalas@hotmail.com
+55 11 99319-0441
Time Frame
Start Date: 2024-12-10
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 60
Treatments
Experimental: Arm 1: Interactive Virtual Reality
Participants in Arm 1 will receive standard postoperative care plus virtual reality (VR) therapy using both interactive games and passive imagery. The goal is to reduce opioid consumption and improve recovery through immersive distraction. VR sessions will be held three times daily, lasting 30-45 minutes each, for five consecutive postoperative days or until discharge. Games such as Fruit Ninja 2, Beat Saber, and Oculus First Contact offer stimulating experiences, while passive content from YouTube VR provides relaxing visual environments. Patients will be trained to operate the VR device and choose content based on their preference. All sessions will be supervised by the study team to ensure proper use and maximize therapeutic effect.
Experimental: Arm 2: Passive Virtual Reality
Participants in Arm 2 will receive standard postoperative care plus virtual reality (VR) therapy focused solely on passive imagery for distraction. VR sessions will occur three times daily, each lasting 30-45 minutes, for five consecutive postoperative days or until discharge. Patients will view calming, immersive content-such as nature scenes and relaxing landscapes-available on platforms like YouTube VR. These experiences aim to reduce opioid consumption and improve recovery by decreasing pain perception. Participants will be trained to use the device and guided by the study team, who will supervise each session to ensure proper use and maximize therapeutic effect.
No_intervention: Arm 3: Standard Postoperative Care (Control)
Participants in Arm 3 will serve as the control group, receiving standard postoperative care without virtual reality (VR) intervention. Standard care includes institutional pain management protocols, such as the use of opioids and non-opioid analgesics after cardiac or thoracic surgery. No immersive or distraction-based technologies will be provided. This group serves as a baseline for comparison with the VR groups (Groups 1 and 2), enabling evaluation of the impact of VR on opioid consumption, pain perception, and recovery outcomes. Data from Group 3 will help assess the added value of VR as a complementary tool in postoperative care.
Sponsors
Leads: Filomena R B G Galas

This content was sourced from clinicaltrials.gov