Clinical trial Recruiting at 1 site Interventional Ages 16 to 40

Using virtual reality to reduce opioid use after heart and thoracic operations

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

Run by Instituto do Coracao · NCT07063394 · Data updated 2026-11-12

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

Study typeInterventional
Ages16 Years to 40 Years
SexAll
Enrollment60 (estimated)
SponsorInstituto do Coracao
Government
Locations1 site (São Paulo, São Paulo)
StatusRecruiting
StartedDecember 10, 2024
Main results expectedMay 15, 2026
Study endsDecember 30, 2027
Registry record updatedApril 15, 2026
Trial IDNCT07063394 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.