Virtual Reality in Reducing Acute Orthopedic Pain

Not Applicable

Not yet recruiting

• Conditions: Fractures
• Interventions: Other: virtual reality

• Registration Number: NCT06624969
• Lead Sponsor: Mayo Clinic

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-17
• Study First Submitted QC: 2024-10-01
• Study First Posted: 2024-10-03
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-11
• Study Start: 2025-05
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual reality	virtual reality	Intervention with virtual reality

Primary Outcome Measures

Name	Time	Method
opioid use	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

Secondary Outcome Measures

Name	Time	Method
reduction in anxiolytics	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
hospital length of stay	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	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
User experiences	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