Actively Recruiting

Phase Not Applicable
Age: 16Years - 40Years
All Genders
NCT07063394

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

Led by Filomena R B G Galas · Updated on 2026-04-15

60

Participants Needed

1

Research Sites

159 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 16Years - 40Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 or higher
Not Eligible

You will not qualify if you...

  • Visual impairments
  • Cognitive impairment with MMSE score 24 or lower
  • Severe upper limb motor limitations
  • Claustrophobia
  • Spatial disorientation
  • Motion sickness or vestibular disorders
  • Infectious or contagious diseases

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Incor - Heart Institute - University of Sao Paulo

São Paulo, São Paulo, Brazil, 05403000

Actively Recruiting

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Research Team

F

Filomena Regina B Galas, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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