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Recruiting NCT06624969

Virtual Reality in Reducing Acute Orthopedic Pain

No phase Interventional Fractures

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: virtual reality.
Who it may be relevant to
Registry conditions: Fractures. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other virtual reality
    Virtual reality program to reduce pain in orthopedic fractures

Primary outcome measures

  • opioid use [Time frame: From date of enrollment which begins at hospital admission until the date of hospital discharge, assessed up to 5 weeks]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mayo Clinic Hospital — Jacksonville

Identifiers

NCT: NCT06624969 · 24-009261

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗