FracturesNCT06624969
Virtual Reality in Reducing Acute Orthopedic Pain
A study testing virtual reality in people with Fractures, run by Mayo Clinic at 1 site in United States.
Trial summary
The primary aim of this research is to show that a virtual reality (VR) service line is feasible and can sustain itself with the ability to take care of patients. Additionally, the investigators aim to learn about the limitations of a service line and provide a pathway for future improvements in building a VR service… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fractures
- What is being tested?
- virtual reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2026to Dec 2028
- Phase
- Interventional
- 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
Who may be able to join
- Hospitalized with an orthopedic fracture
- Able to participate fully in all aspects of the study
- Able to understand and sign informed consent
- Individuals with unaided vision or those who can correct their vision using contact lenses
Who cannot join
- Non-English speaking
- Self-reported history of acute and/or chronic severe motion sickness
- The presence of a facial/head deformity that will prohibit the wearing of a VR head mounted display.
- Legally blind or deaf
- Have had a seizure within the past 1 year
- Have current (within the past 30 days) clinically significant acute or chronic progressive or unstable/uncontrolled neurologic disorder
- Have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic Hospital
Jacksonville, Florida, 32224
3142832296
About this study
The primary aim of this research is to show that a virtual reality (VR) service line is feasible and can sustain itself with the ability to take care of patients. Additionally, the investigators aim to learn about the limitations of a service line and provide a pathway for future improvements in building a VR service line that is optimally aligned with the user's needs. Secondary aims are to evaluate the clinical aspects of the patient's outcomes including length of stay, morphine equivalents in pain medicine required during the hospital stay, and user experiences.
- Conditions
- Fractures
- Being tested
- virtual reality
- Keywords
- pain control, orthopedic, fracture, hospital
- Medical subject headings
- Fractures, Bone, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual realityOther
Virtual reality program to reduce pain in orthopedic fractures
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality | Experimental | Intervention with virtual reality Receives: Other: virtual reality |
| Standard of care | No intervention | No virtual reality intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
opioid use
Change in opioid equivalents during hospital stay from hospital admission to discharge
Measured: From date of enrollment which begins at hospital admission until the date of hospital discharge, assessed up to 5 weeks
Secondary outcomes (4)
reduction in anxiolytics
Change in anxiolytics during the hospital admission from admission to discharge
Measured: From date of enrollment which begins at hospital admission until the date of hospital discharge, assessed up to 5 weeks
hospital length of stay
Measured: From date of enrollment which begins at hospital admission until the date of hospital discharge, assessed up to 5 weeks
reduction in sleep aids prescribed
Change in sleep aids prescribed during the hospital stay from hospital admission to discharge
Measured: From date of enrollment which begins at hospital admission until the date of hospital discharge, assessed up to 5 weeks
User experiences
Subjective user experiences with the virtual reality program obtained at hospital discharge using a questionnaire with Likert scale answers showing higher scores to have better experiences with the intervention
Measured: obtained once on the day of hospital discharge, up to 5 weeks from study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start23 Apr 2026
- Primary completionJan 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FracturesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott A. Helgeson, Mayo Clinic
- Investigators
- Scott Helgeson, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624969
- Sponsor's protocol ID
- 24-009261
- Status last verified
- May 2026
- First submitted
- 17 Sep 2024
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality in Reducing Acute Orthopedic Pain
- ClinicalTrials.gov ID
- NCT06624969
- Acronym / sponsor ID
- 24-009261
- Conditions
- Fractures
- Keywords
- pain control, orthopedic, fracture, hospital
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 23 Apr 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 3 Oct 2024 (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 primary aim of this research is to show that a virtual reality (VR) service line is feasible and can sustain itself with the ability to take care of patients. Additionally, the investigators aim to learn about the limitations of a service line and provide a pathway for future improvements in building a VR service line that is optimally aligned with the user's needs. Secondary aims are to evaluate the clinical aspects of the patient's outcomes including length of stay, morphine equivalents in pain medicine required during the hospital stay, and user experiences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality | Experimental | Other: virtual realityIntervention with virtual reality |
| Standard of care | No intervention | –No virtual reality intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hospitalized with an orthopedic fracture
- Able to participate fully in all aspects of the study
- Able to understand and sign informed consent
- Individuals with unaided vision or those who can correct their vision using contact lenses
Key exclusion criteria (7 listed)
- Non-English speaking
- Self-reported history of acute and/or chronic severe motion sickness
- The presence of a facial/head deformity that will prohibit the wearing of a VR head mounted display.
- Legally blind or deaf
- Have had a seizure within the past 1 year
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 realityVirtual reality program to reduce pain in orthopedic fractures | Other | Virtual reality |
Primary outcome
opioid use
Time frame: From date of enrollment which begins at hospital admission until the date of hospital discharge, assessed up to 5 weeks
Change in opioid equivalents during hospital stay from hospital admission to discharge
4 secondary outcomes
reduction in anxiolytics
Time frame: From date of enrollment which begins at hospital admission until the date of hospital discharge, assessed up to 5 weeks
hospital length of stay
Time frame: From date of enrollment which begins at hospital admission until the date of hospital discharge, assessed up to 5 weeks
reduction in sleep aids prescribed
Time frame: From date of enrollment which begins at hospital admission until the date of hospital discharge, assessed up to 5 weeks
User experiences
Time frame: obtained once on the day of hospital discharge, up to 5 weeks from study enrollment
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 5 May 2026.
- Individual participant dataSharing planned: No
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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.
Scott Helgeson, 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?
A study testing virtual reality in people with Fractures, 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 4 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: looking for participants now, as of the sponsor's last update on 5 May 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?
Contact Scott Helgeson, MD (904-953-2000, helgeson.scott@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
opioid use (time frame: From date of enrollment which begins at hospital admission until the date of hospital discharge, assessed up to 5 weeks). 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 5 May 2026.