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

Knee Arthropathy Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05112302
• Other study ID #: 21-005305
• Status: Enrolling by invitation
• Start date: August 17, 2021
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Hip Injuries
• Knee Arthropathy

Intervention

Other:
• Virtual reality
Use of virtual reality goggles during procedure

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Impact of virtual reality on pharmacological therapy doses	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.	Up to 2 hours
Secondary	Impact of virtual reality on patient's perioperative temperature	Evaluate if utilizing virtual reality has a positive impact in preventing patient hypothermia intra- and post-operatively.	Up to 3 hours