Testing the Timing and Application of Virtual Reality Distraction During Knee Injections in a VA Pain Clinic

NCT07884851 | Not Yet Recruiting

• 1 other identifier: 2026P001360
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn whether virtual reality (VR) can be added to routine knee injection appointments at a VA outpatient pain clinic without slowing down or disrupting clinic operations. The study will enroll 45 adult veterans who are scheduled for a knee injection at the Atlanta VA Arcadia pain clinic. The main questions it aims to answer are

• Can a VR headset be set up and used during a knee injection with minimal time disruptions?
• How many patients agree to take part, how many need to stop using the headset early, and how satisfied are patients and clinicians with the experience? Researchers will compare patients who wear a VR headset during their injection to patients who receive the usual injection without VR. This will show whether VR may change anxiety, time spent thinking about pain, satisfaction, and memory of the procedure. Participants will:
• Be assigned by chance to one of two groups. Two out of every three participants will use VR, and one out of every three will receive usual care only.
• If in the VR group, wear a headset showing a virtual environment with little motion. A research team member will place the headset before the needle goes in and remove it after the injection is finished.
• Receive their scheduled knee injection as usual from their clinician.
• Complete a short survey right after the procedure. Taking part happens during one clinic visit and takes about 30 minutes. The knee injection itself is standard care and is not changed by the study.

Conditions

Feasibility Studies; Distraction; Immersive Virtual Reality; Pain Management; Injection Pain Prevention; Virtual Reality

Keywords

virtual reality; injection; veterans; workflow; pain management; acute procedural pain

Outcome Measures

Primary Outcomes (8)

• Enrollment Rate

  Proportion of eligible patients approached who provide written informed consent, calculated as the number consented divided by the number eligible and approached. Pre-specified feasibility benchmark: enrollment rate of 60% or greater.

  Throughout the enrollment period (approximately 8 weeks)

• Virtual Reality Setup Time

  Time in minutes from VR headset placement to participant engagement with the VR environment, recorded by stopwatch on the workflow timing log by the research coordinator. Assessed in the VR + standard of care arm only.

  Day 1, from headset placement (after the pre-procedure timeout) to VR engagement, before needle insertion

• Virtual Reality Discontinuation Rate

  Proportion of VR + standard of care participants requiring headset removal before needle withdrawal and dressing application, with documented reason (participant request, observed distress or adverse reaction, or treating physician determination that the headset interferes with the procedure). Pre-specified feasibility benchmark: discontinuation rate below 10%.

  Day 1, from headset placement through needle withdrawal

• Total Procedure Duration

  Time in minutes from signing of the clinical consent for the knee injection to needle withdrawal and dressing application, recorded by stopwatch on the workflow timing log. Durations will be compared between arms to estimate time added by VR. Pre-specified feasibility benchmark: VR adds 5 minutes or less to total procedure duration.

  Day 1, from signing of procedure consent to dressing application

• Patient Satisfaction With the Procedure

  Participant-rated overall satisfaction with the knee injection procedure on a 0-10 Numerical Rating Scale (0 = not satisfied, 10 = completely satisfied). Higher scores indicate greater satisfaction. Reported by arm.

  Day 1, immediately following the procedure

• Provider-Reported Workflow Disruption

  Proportion of procedures in which the treating provider reports that the VR headset required modification to standard procedure steps (yes/no), with optional free-text description.

  Day 1, immediately following the procedure

• Provider-Reported Patient Comfort

  Treating provider's rating of how comfortable the patient appeared during the procedure on a 0-10 Numerical Rating Scale (0 = not comfortable at all, 10 = extremely comfortable). Higher scores indicate greater perceived comfort. Reported by arm.

  Day 1, immediately following the procedure

• Willingness to Use Virtual Reality Again

  Proportion of VR + standard of care participants answering "yes" to whether they would enjoy using VR in this procedure again. Pre-specified feasibility benchmark: 60% or greater.

  Day 1, immediately following the procedure

Secondary Outcomes (5)

• Procedural Pain Ratings

  Day 1, immediately following the procedure

• Anxiety During the Procedure, Adjusted for Baseline

  Baseline (Day 1, after consent and before randomization) and Day 1 immediately following the procedure

• Change in Cybersickness Symptoms From Baseline

  Baseline (Day 1, before randomization) and Day 1 immediately following the procedure

• Perceived Procedure Experience

  Day 1, immediately following the procedure

• Perceived Distraction by the Virtual Environment

  Day 1, immediately following the procedure

Study Arms (2)

Standard of Care

NO INTERVENTION

Participants receive their scheduled intra-articular knee injection per standard clinical practice with no additional intervention. Participants complete a post-procedure survey, and the treating provider completes a provider survey.

VR Plus Standard of Care

EXPERIMENTAL

Participants receive their scheduled intra-articular knee injection per standard clinical practice, with the addition of an immersive virtual reality headset (SustainVR). After consent and patient positioning, a trained research team member places the headset and provides a brief orientation to the device and virtual environment. The headset remains on before and throughout needle insertion and the full injection and is removed after needle withdrawal. The headset is removed immediately if the participant requests it, if an adverse reaction is observed, or if the treating physician determines it interferes with the procedure. Participants complete a post-procedure survey, and the treating provider completes a provider survey.

Device: Immersive Virtual Reality

Interventions

Immersive Virtual Reality DEVICE

Commercially available, non-invasive, head-mounted immersive virtual reality system used as a non-pharmacologic distraction adjunct during a standard of care intra-articular knee injection. The virtual environment contains low levels of motion to reduce the risk of cybersickness. A trained research team member places the headset after patient positioning and before needle insertion, provides a brief orientation, and removes it after needle withdrawal. Delivered once, during a single clinic visit. The device does not replace any component of standard clinical care.

Also known as: SustainVR, VR

VR Plus Standard of Care

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 years or older
• Presenting to the Atlanta VA Health Care System Arcadia outpatient pain clinic for a scheduled intra-articular knee injection
• Able to provide written informed consent

You may not qualify if:

• Inability to read, write, and comprehend English
• Inability to complete study measures or questionnaires
• Any physical or mental health condition that, in the opinion of the principal investigator or research staff, precludes or may negatively impact the ability to participate
• History of severe claustrophobia
• Pregnancy
• Any medical condition that may prevent the use of virtual reality, including current or prior diagnosis of epilepsy or seizure disorder, hypersensitivity to flashing light or motion, migraines, any medical condition predisposing to nausea or dizziness (e.g., vertigo, inner ear conditions, motion sickness susceptibility), dementia, absence of stereoscopic vision, or severe hearing impairment
• Injury to the eyes, face, or neck that prevents comfortable use of a VR headset
• Open facial skin lesions, rashes, or draining wounds in headset contact areas

Sponsors & Collaborators

• Atlanta VA Medical Center: lead

Related Publications (5)

• Nemesanszky E. [The significance of myocardium-specific isoenzymes in the diagnosis of myocardial infarct]. Orv Hetil. 1982 Aug 15;123(33):2037-43. No abstract available. Hungarian.

  PMID: 7145389 BACKGROUND

• Krishnamurthy A, Lang AE, Pangarkar S, Edison J, Cody J, Sall J. Synopsis of the 2020 US Department of Veterans Affairs/US Department of Defense Clinical Practice Guideline: The Non-Surgical Management of Hip and Knee Osteoarthritis. Mayo Clin Proc. 2021 Sep;96(9):2435-2447. doi: 10.1016/j.mayocp.2021.03.017.

  PMID: 34481599 BACKGROUND

• Hoffman HG, Chambers GT, Meyer WJ 3rd, Arceneaux LL, Russell WJ, Seibel EJ, Richards TL, Sharar SR, Patterson DR. Virtual reality as an adjunctive non-pharmacologic analgesic for acute burn pain during medical procedures. Ann Behav Med. 2011 Apr;41(2):183-91. doi: 10.1007/s12160-010-9248-7.

  PMID: 21264690 BACKGROUND

• Lier EJ, de Vries M, Steggink EM, Ten Broek RPG, van Goor H. Effect modifiers of virtual reality in pain management: a systematic review and meta-regression analysis. Pain. 2023 Aug 1;164(8):1658-1665. doi: 10.1097/j.pain.0000000000002883. Epub 2023 Mar 22.

  PMID: 36943251 BACKGROUND

• Teh JJ, Pascoe DJ, Hafeji S, Parchure R, Koczoski A, Rimmer MP, Khan KS, Al Wattar BH. Efficacy of virtual reality for pain relief in medical procedures: a systematic review and meta-analysis. BMC Med. 2024 Feb 14;22(1):64. doi: 10.1186/s12916-024-03266-6.

  PMID: 38355563 BACKGROUND

Related Links

• VA Diffusion Marketplace: Re-engaging Veterans in Pain Through Immersive Technology

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

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

Study Officials

• Mercy L Udoji, MD

  Atlanta VA Medical Center, Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mercy Udoji, MD

CONTACT

404-297-1540‬; Mercy.Udoji@va.gov

Asher L Seibel, AEMT

CONTACT

206-698-5082; alseibe@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mercy Udoji, MD

Model Details: Two-arm, parallel-group, randomized pilot feasibility trial. Participants are randomized 2:1 to VR plus standard of care (n=30) or standard of care alone (n=15) after informed consent, using sequentially numbered, sealed, opaque envelopes prepared in advance by a study team member. Each participant completes a single study visit within their scheduled knee injection appointment.

Study Record Dates

• First Submitted: October 14, 2026
• First Posted: October 21, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: October 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share