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| ID | Type | Description | Link |
|---|---|---|---|
| 6.889.108 | Other Identifier | Plataforma Brasil |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Interactive Virtual Reality | Experimental | 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. |
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| Arm 2: Passive Virtual Reality | Experimental | 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. |
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| Arm 3: Standard Postoperative Care (Control) | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interactive Virtual Reality | Device | Patients 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Opioid Consumption | Measured by the total dose of opioids administered postoperatively, converted to Morphine Milligram Equivalents (MME), over the first 5 days. | From the end of surgery up to 5 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Nausea and Vomiting | Frequency of postoperative nausea and vomiting episodes | Within 5 days after surgery |
| Length of ICU Stay | Number of days spent in the ICU |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Filomena Regina B Galas, PhD | Contact | +55 11 99319-0441 | filomenagalas@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Filomena Regina B. G. Galas, MD PhD | Instituto do Coracao (InCor) - HCFMUSP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Incor - Heart Institute - University of Sao Paulo | Recruiting | São Paulo | São Paulo | 05403000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37556082 | Result | Kodvavi MS, Asghar MA, Ghaffar RA, Nadeem I, Bhimani S, Kumari V, Rabbani A, Iqbal M, Naeem R, Nasir AM, Hassan SS, Ghazni MS. Effectiveness of virtual reality in managing pain and anxiety in adults during periprocedural period: a systematic review and meta-analysis. Langenbecks Arch Surg. 2023 Aug 9;408(1):301. doi: 10.1007/s00423-023-03046-5. | |
| 37355243 |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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This is a prospective, randomized, single-center, parallel-group trial with three arms. Participants undergoing elective cardiac or thoracic surgery will be randomized in a 1:1:1 ratio to receive: (1) standard postoperative care plus virtual reality (VR) with interactive games and/or passive imagery; (2) standard care plus VR with passive contemplative imagery only; or (3) standard postoperative care alone (control). The VR intervention will be administered over five consecutive postoperative days, with three supervised sessions per day, each lasting 30 to 45 minutes.
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| Passive Virtual Reality | Device | Patients 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. |
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| Within 5 days after surgery |
| Length of Hospital Stay | Number of days hospitalized | Within 30 days after surgery |
| Length of Mechanical Ventilation | Hours of mechanical ventilation | Within 5 days after surgery |
| Length of Non-Invasive Ventilation | Hours of non-invasive ventilation | Within 5 days after surgery |
| Occurrence of Paralytic Ileus | Presence of paralytic ileus postoperatively | Within 5 days after surgery |
| Patient Satisfaction | Patient satisfaction will be assessed using a Likert scale ranging from 1 to 5, where 1 indicates "very dissatisfied" and 5 indicates "very satisfied". Higher scores represent a better outcome (greater satisfaction). | Within 5 days after surgery |
| Postoperative Pain | Pain intensity will be measured using the Visual Analog Scale (VAS), which ranges from 0 to 10. A score of 0 represents "no pain" and 10 represents the "worst pain imaginable". Higher scores represent a worse outcome (greater pain intensity). | Within 5 days after surgery |
| Lind A, Ahsan M, Totzeck M, Al-Rashid F, Haddad A, Dubler S, Brenner T, Skarabis A, El Gabry M, Rassaf T, Janosi RA. Virtual reality-assisted distraction during transcatheter aortic valve implantation under local anaesthesia: A randomised study. Int J Cardiol. 2023 Sep 15;387:131130. doi: 10.1016/j.ijcard.2023.131130. Epub 2023 Jun 22. |