Virtual Reality in Reducing Acute Orthopedic Pain

May 4, 2026 updated by: Scott A. Helgeson, Mayo Clinic
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic Hospital
        • Contact:
          • Phone Number: 3142832296

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Hospitalized with an orthopedic fracture
  2. Able to participate fully in all aspects of the study
  3. Able to understand and sign informed consent

  4. Individuals with unaided vision or those who can correct their vision using contact lenses

    Exclusion Criteria:

  5. Non-English speaking
  6. Self-reported history of acute and/or chronic severe motion sickness
  7. The presence of a facial/head deformity that will prohibit the wearing of a VR head mounted display.
  8. Legally blind or deaf
  9. Have had a seizure within the past 1 year
  10. Have current (within the past 30 days) clinically significant acute or chronic progressive or unstable/uncontrolled neurologic disorder
  11. Have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual reality
Intervention with virtual reality
Other: virtual reality
Virtual reality program to reduce pain in orthopedic fractures
No Intervention: Standard of care
No virtual reality intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From date of enrollment which begins at hospital admission until the date of hospital discharge, assessed up to 5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change in anxiolytics during the hospital admission from admission to discharge
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
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
Change in sleep aids prescribed during the hospital stay from hospital admission to discharge
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
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
obtained once on the day of hospital discharge, up to 5 weeks from study enrollment

Collaborators and Investigators

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

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Scott Helgeson, MD, Mayo Clinic

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)

April 23, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

September 17, 2024

First Submitted That Met QC Criteria

October 1, 2024

First Posted (Actual)

October 3, 2024

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-009261

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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