Evaluation of Virtual Reality for Reducing Opioid Use After Cardiac and Thoracic Surgery (VR-USP)

Filomena R B G Galas

Status: Enrolling

Conditions: Heart Surgery; Pain; Opioid; Virtual Reality; Thoracic Surgery

Treatments: Device: Passive Virtual Reality; Device: Interactive Virtual Reality

Study type: Interventional

Funder types: Other

Identifiers

NCT07063394

6.889.108 (Other Identifier)

Details and patient eligibility

About

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.

Full description

Postoperative pain management in major cardiac and thoracic surgeries remains a significant clinical challenge due to the side-effect profile of opioids, including respiratory depression and dependency. This study explores Virtual Reality (VR) as a non-pharmacological adjunct based on the gate control theory and the concept of immersive distraction. By engaging multiple sensory faculties, VR aims to compete with nociceptive stimuli for limited attentional resources, thereby modulating pain perception and reducing the emotional component of the pain experience.

This clinical trial compares two distinct VR modalities to identify the most effective mechanism for pain modulation in a high-complexity surgical setting. The Interactive VR arm utilizes high-fidelity devices to engage patients in tasks requiring motor coordination and active cognitive processing, such as interactive gaming. This level of engagement is hypothesized to induce a deeper state of presence. The Passive VR arm focuses on contemplative, 360-degree immersive environments designed to induce physiological relaxation and calmness through visual immersion in tranquil natural settings.

The intervention protocol is standardized to begin on the first postoperative day at the Heart Institute (InCor). Each session is supervised by the research team to ensure proper equipment usage and to monitor for potential adverse effects, such as cybersickness or spatial disorientation. By comparing these immersive levels against a control group receiving standard institutional care, the study seeks to quantify the opioid-sparing effect of digital therapeutics. Statistical analysis will utilize multivariate models to identify associations between VR exposure and improved recovery indicators, providing evidence for the integration of VR into multimodal analgesia strategies.

Enrollment: 60 estimated patients

Sex: All

Ages: 16 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Arm 1: Interactive Virtual Reality

Experimental group

Description:

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.

Treatment:

Device: Interactive Virtual Reality

Arm 2: Passive Virtual Reality

Experimental group

Description:

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.

Treatment:

Device: Passive Virtual Reality

Arm 3: Standard Postoperative Care (Control)

No Intervention group

Description:

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.