Knee ArthropathyNCT05112302
A Study to Evaluate Virtual Reality As Adjunct to Anesthesia During Orthopedic Surgery
An observational study of Knee Arthropathy and Hip Injuries, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Arthropathy, Hip Injuries
- What is being tested?
- Virtual reality
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2021to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing elective orthopedic surgery
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- Being tested
- Virtual reality
- Keywords
- virtual reality, knee arthroplasty, hip arthroplasty
- Medical subject headings
- Hip Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityOther
Use of virtual reality goggles during procedure
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality | Not described Receives: Other: Virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of virtual reality on anxiety level
Evaluate patients' satisfaction with using virutal reality and reduction in anxiety during orthopedic procedures
Measured: Up to 2 hours
Secondary outcomes (2)
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.
Measured: Up to 2 hours
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.
Measured: Up to 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start17 Aug 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthropathyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klaus D. Torp, Mayo Clinic
- Investigators
- Klaus Torp, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112302
- Sponsor's protocol ID
- 21-005305
- Status last verified
- Jan 2026
- First submitted
- 13 Oct 2021
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05112302
- Acronym / sponsor ID
- 21-005305
- Conditions
- Knee Arthropathy, Hip Injuries
- Keywords
- virtual reality, knee arthroplasty, hip arthroplasty
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 17 Aug 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual reality | – | Other: Virtual reality |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective orthopedic surgery
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual realityUse of virtual reality goggles during procedure | Other | Virtual reality |
Primary outcome
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
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Klaus Torp, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Arthropathy and Hip Injuries, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of virtual reality on anxiety level (time frame: Up to 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026; AzTrials last refreshed its copy on 28 Oct 2026.