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

March 12, 2024 updated by: Klaus D. Torp, Mayo Clinic

Use of Virtual Reality as an Adjunct for Anesthesia During Orthopedic Procedures Under Regional or Central Neuraxial Nerve Block. A Pilot and Feasibility Study

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic in Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients undergoing elective orthopedic surgery

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Virtual reality
Other: Virtual reality
Use of virtual reality goggles during procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of virtual reality on anxiety level
Time Frame: Up to 2 hours
Evaluate patients' satisfaction with using virutal reality and reduction in anxiety during orthopedic procedures
Up to 2 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Klaus Torp, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2021

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

October 13, 2021

First Submitted That Met QC Criteria

November 5, 2021

First Posted (Actual)

November 8, 2021

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-005305

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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