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

Official title

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

Overview

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.

Detailed 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.

Interventions

• Device Interactive Virtual Reality
  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.
• Device Passive Virtual Reality
  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

Primary outcome measures

• Reduction in Opioid Consumption [Time frame: From the end of surgery up to 5 days after surgery]

Secondary outcome measures (8)

• Occurrence of Nausea and Vomiting [Time frame: Within 5 days after surgery]
• Length of ICU Stay [Time frame: Within 5 days after surgery]
• Length of Hospital Stay [Time frame: Within 30 days after surgery]
• Length of Mechanical Ventilation [Time frame: Within 5 days after surgery]
• Length of Non-Invasive Ventilation [Time frame: Within 5 days after surgery]
• Occurrence of Paralytic Ileus [Time frame: Within 5 days after surgery]
• Patient Satisfaction [Time frame: Within 5 days after surgery]
• Postoperative Pain [Time frame: Within 5 days after surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Brazil · 1 center

• Incor - Heart Institute - University of Sao Paulo — São Paulo

Publications

• 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. PMID 37556082
• 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. PMID 37355243

Identifiers

NCT: NCT07063394 · 6.889.108 · 6.889.108

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗