Using virtual reality to reduce opioid use after heart and thoracic operations
Evaluation of the Efficacy of Virtual Reality as a Therapeutic Method to Reduce Opioid Consumption in Postoperative Cardiac and Thoracic Surgery
This study will test whether adding virtual reality sessions after cardiac or thoracic surgery can lower opioid use in patients aged 16–40.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 16 Years to 40 Years |
| Sex | All |
| Sponsor | Instituto do Coracao Government |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT07063394 on ClinicalTrials.gov |
What this trial studies
This single-center, randomized trial at InCor will enroll 60 patients aged 16–40 undergoing elective cardiac or thoracic procedures and randomize them to interactive VR, passive VR, or standard care without VR. VR interventions consist of three supervised sessions per day lasting 30–45 minutes for the first five postoperative days or until discharge. The primary outcome is postoperative opioid consumption, with safety monitoring for adverse effects such as cybersickness or spatial disorientation. The trial compares active, interactive engagement versus passive immersive environments to determine which modality, if any, provides greater pain modulation and opioid-sparing effects.
Who should consider this trial
Good fit: Ideal candidates are patients aged 16–40 with preserved cognition (MMSE ≥ 25) undergoing elective cardiac or specified thoracic surgeries at the Heart Institute (InCor) of the University of São Paulo.
Not a fit: Patients with visual impairment, significant cognitive or upper-limb motor limitations, vestibular disorders, severe motion sickness, claustrophobia, or active infectious conditions are excluded and unlikely to benefit from the VR interventions.
Why it matters
Potential benefit: If successful, the intervention could reduce postoperative opioid requirements and their side effects, improving recovery and patient comfort.
How similar studies have performed: Smaller trials and systematic reviews in acute and procedural pain settings suggest VR can reduce pain and opioid needs, but randomized evidence in major cardiac and thoracic postoperative care remains limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
São Paulo, São Paulo
- Incor - Heart Institute - University of Sao Paulo — São Paulo, São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Filomena Regina B. G. Galas, MD PhD — Instituto do Coracao (InCor) - HCFMUSP
- Study coordinator: Filomena Regina B Galas, PhD
- Email: filomenagalas@hotmail.com
- Phone: +55 11 99319-0441
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.