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

NCT05112302 | Enrolling By Invitation

• 1 other identifier: 21-005305
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Arthropathy; Hip Injuries

Keywords

virtual reality; knee arthroplasty; hip arthroplasty

Outcome Measures

Primary Outcomes (1)

• Impact of virtual reality on anxiety level

  Evaluate patients' satisfaction with using virutal reality and reduction in anxiety during orthopedic procedures

  Up to 2 hours

Secondary Outcomes (2)

• Impact of virtual reality on pharmacological therapy doses

  Up to 2 hours

• Impact of virtual reality on patient's perioperative temperature

  Up to 3 hours

Study Arms (1)

Virtual reality

Other: Virtual reality

Interventions

Virtual reality OTHER

Use of virtual reality goggles during procedure

Virtual reality

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing elective orthopedic surgery

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jackson, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Hip Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Klaus Torp, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: November 8, 2021
• Study Start: August 17, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

US (1)