Actively Recruiting

Phase Not Applicable
Age: 16Years - 40Years
All Genders
ID07063394

Evaluation of the Efficacy of Virtual Reality to Reduce 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

84 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This clinical trial evaluates virtual reality (VR) as an additional therapy to reduce opioid use after cardiac and thoracic surgeries. It includes 60 patients aged 16 to 40 undergoing surgeries such as valve replacements, pulmonary decortication, and video-assisted thoracic procedures. The study compares two types of VR approaches—interactive and passive—with standard care to see if VR can improve pain control and recovery while lowering opioid use and related side effects. Participants are randomly assigned to one of three groups. The Interactive VR group receives standard anesthesia plus VR with games and immersive environments. The Passive VR group receives standard anesthesia plus VR showing relaxing 360-degree videos. The Control group receives only standard postoperative care without VR. VR sessions occur three times daily for 30 to 45 minutes over five postoperative days or until hospital discharge, supervised to ensure proper use and safety. During the study, patients will be assessed for total opioid consumption via prescriptions and patient-controlled analgesia pumps. Researchers will also monitor pain levels using the Visual Analogue Scale, nausea and vomiting, ventilation duration, ICU and hospital stays, paralytic ileus occurrence, patient satisfaction, and cognitive function with the Mini-Mental State Examination. The study aims to provide detailed insights into VR’s role as a supportive pain management tool in these surgeries.

CONDITIONS

Brief 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 65 25
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery

Duration - Day of surgery

Participants undergo elective cardiac or thoracic surgery at the Heart Institute (InCor).

1 visit (in-person)

Implementation

Duration - Five consecutive postoperative days or until discharge

Participants receive Virtual Reality therapy starting on the first postoperative day. The therapy includes either interactive VR sessions involving active cognitive and motor tasks or passive VR sessions featuring immersive natural environments. Sessions are supervised by the research team to ensure proper equipment use and monitor for side effects.

3 sessions daily, each lasting 30 to 45 minutes, supervised by the study team

Post-operative Follow-up

Duration - Up to 5 days after surgery

Participants are monitored for recovery outcomes, including opioid use, pain levels, and any adverse effects during hospitalization.

Daily assessments during hospital stay

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

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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Published Research Related To This Trial

Effectiveness of virtual reality in managing pain and anxiety in adults during periprocedural period: a systematic review and meta-analysis.

Muhammad Suraim Kodvavi, Mustafa Ali Asghar, Rimmel Abdul Ghaffar...

https://pubmed.ncbi.nlm.nih.gov/37556082

Virtual reality-assisted distraction during transcatheter aortic valve implantation under local anaesthesia: A randomised study.

Alexander Lind, Majid Ahsan, Matthias Totzeck...

https://pubmed.ncbi.nlm.nih.gov/37355243