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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-40
SponsorFilomena R B G Galas

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

Qualifiers

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

Treatments tested in this trial

  • Interactive Virtual Reality
  • Passive Virtual Reality

Treatment groups

60 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Filomena R B G Galas

Lead sponsor

Instituto do Coracao

Sponsor institution