Virtual Reality in Reducing Acute Orthopedic Pain

NCT06624969 | Recruiting

• 1 other identifier: 24-009261
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Fractures

Keywords

pain control; orthopedic; fracture; hospital

Outcome Measures

Primary Outcomes (1)

• opioid use

  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 Outcomes (4)

• reduction in anxiolytics

  From date of enrollment which begins at hospital admission until the date of hospital discharge, assessed up to 5 weeks

• 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

• User experiences

  obtained once on the day of hospital discharge, up to 5 weeks from study enrollment

Study Arms (2)

Virtual reality

EXPERIMENTAL

Intervention with virtual reality

Other: virtual reality

Standard of care

NO INTERVENTION

No virtual reality intervention

Interventions

virtual reality OTHER

Virtual reality program to reduce pain in orthopedic fractures

Virtual reality

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Hospital

Jacksonville, Florida, 32224, United States

RECRUITING

MeSH Terms

Conditions

Fractures, Bone; Agnosia

Condition Hierarchy (Ancestors)

Wounds and Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Scott Helgeson, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Scott Helgeson, MD

CONTACT

904-953-2000; helgeson.scott@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Assistant Professor of Medicine

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: October 3, 2024
• Study Start: April 23, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)