A Study to Evaluate Virtual Reality As Adjunct to Anesthesia During Orthopedic Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Virtual reality.
- Who it may be relevant to
- Registry conditions: Knee Arthropathy, Hip Injuries. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Use of Virtual Reality as an Adjunct for Anesthesia During Orthopedic Procedures Under Regional or Central Neuraxial Nerve Block. A Pilot and Feasibility Study
Overview
The purpose of this study is to obtain feedback from patients and orthopedic surgeons who agree to use virtual reality (VR ) as an adjunct to standard of care in orthopedic cases under regional or central neuraxial nerve block. This will serve as a preliminary study for future trials to compare outcomes between VR and standard of care vs standard of care only.
Interventions
- Other Virtual reality
Use of virtual reality goggles during procedure
Primary outcome measures
- Impact of virtual reality on anxiety level [Time frame: Up to 2 hours]
Secondary outcome measures (2)
- Impact of virtual reality on pharmacological therapy doses [Time frame: Up to 2 hours]
- Impact of virtual reality on patient's perioperative temperature [Time frame: Up to 3 hours]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years old.
- Patients scheduled for orthopedic procedure under regional or central neuraxial nerve block (anterior primary hip arthroplasty or primary knee arthroplasty).
- Subject willing to participate and able to provide informed consent.
Exclusion criteria
- Age < 18 years old.
- History of motion sickness or blindness.
- Unable to consent due to cognitive difficulty.
- Current diagnosis of epilepsy, dementia, or other neurological disease that may prevent use of VR hardware and software.
Sensitivity to flashing light or motion.
- Recent stroke.
- Injury to the eyes, face, neck, or arms that prevents comfortable use of VR hardware or software, or safe use of the hardware (e.g., open wound, sores, or skin rash on face).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Mayo Clinic in Florida — Jackson
Identifiers
NCT: NCT05112302 · 21-005305