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/Actively Recruiting
Led by Filomena R B G Galas · Updated on 2026-04-15
60
Participants Needed
1
Research Sites
84 weeks
Total Duration
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 approachesinteractive and passivewith 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 VRs role as a supportive pain management tool in these surgeries.
CONDITIONS
Evaluation of Virtual Reality for Reducing Opioid Use After Cardiac and Thoracic Surgery
F
Filomena Regina B Galas, PhD
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Filomena R B G Galas
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo elective cardiac or thoracic surgery at the Heart Institute (InCor).
1 visit (in-person)
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
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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Alexander Lind, Majid Ahsan, Matthias Totzeck...
https://pubmed.ncbi.nlm.nih.gov/37355243/Muhammad Suraim Kodvavi, Mustafa Ali Asghar, Rimmel Abdul Ghaffar...
https://pubmed.ncbi.nlm.nih.gov/37556082/Filomena R B G Galas
Lead Sponsor