A Study to Evaluate Virtual Reality As Adjunct to Anesthesia During Orthopedic Surgery

• Conditions: Knee Arthropathy; Hip Injuries
• Interventions: Other: Virtual reality

• Registration Number: NCT05112302
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-17
• Study First Submitted: 2021-10-13
• Study First Submitted QC: 2021-11-05
• Study First Posted: 2021-11-08
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-15
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 50

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.

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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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Virtual reality	Virtual reality	-

Primary Outcome Measures

Name	Time	Method
Impact of virtual reality on anxiety level	Up to 2 hours	Evaluate patients' satisfaction with using virutal reality and reduction in anxiety during orthopedic procedures

Secondary Outcome Measures

Name	Time	Method
Impact of virtual reality on patient's perioperative temperature	Up to 3 hours	Evaluate if utilizing virtual reality has a positive impact in preventing patient hypothermia intra- and post-operatively.
Impact of virtual reality on pharmacological therapy doses	Up to 2 hours	Elucidate the impact of VR on pharmacological therapy doses required for proper analgesia and anxiolysis and on reduction of drug side effects in patient using VR during surgeries.

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States