An interventional study of Immersive Virtual Reality in Pain Management, Injection Pain Prevention and Virtual Reality, sponsored by Atlanta VA Medical Center. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Atlanta VA Medical Center · Not applicable, Interventional, and Device feasibility
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
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:
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.
Background: Intra-articular knee injections are among the most common outpatient procedures for managing chronic knee pain, including knee osteoarthritis, a condition that disproportionately affects veterans. These procedures are often associated with periprocedural pain and anxiety, which are commonly managed with pharmacologic options such as opioids or benzodiazepines that carry risks including respiratory depression and dependence. Immersive VR is a non-pharmacologic approach with a growing evidence base for reducing procedural pain across many clinical settings. However, no published studies have evaluated VR during knee injections, and little is known about how VR can be integrated into the operational demands of a busy outpatient pain clinic.
Design: This is a single-site, two-arm, parallel-group, open-label randomized pilot feasibility trial at the Atlanta VA Healthcare System Arcadia outpatient pain clinic. Following informed consent, participants are randomized 2:1 to VR plus standard of care or standard of care alone using sequentially numbered, sealed, opaque envelopes prepared in advance. No stratification is used. The 2:1 allocation was chosen to maximize VR exposure and safety data.
Intervention: In the VR arm, a trained research team member places a commercially available immersive VR headset (SustainVR) after consent and patient positioning but before needle insertion, and provides a brief orientation to the device. The headset remains on through needle insertion and the full injection and is removed after needle withdrawal. SustainVR is a consumer wellness device used here as a non-pharmacologic adjunct, not a replacement for any part of standard care. All injections and medications are delivered per standard clinical practice.
Feasibility benchmarks: Feasibility will be defined a priori as an enrollment rate of at least 60%, a VR discontinuation rate below 10%, VR setup adding 5 minutes or less to total procedure duration, and willingness to use VR again reported by at least 60% of VR arm participants.
Analysis: Feasibility and workflow outcomes will be summarized descriptively. Patient- and provider-reported comparisons between arms are exploratory and intended to estimate effect sizes and variability for a future fully powered trial.
Safety: VR-related adverse events are monitored in real time by the research coordinator and treating physician. The study will be paused for review if VR-related adverse events occur in more than 20% of VR arm participants.
1,269 studies on the registry are indexed under Agnosia; 524 are open to participants now.
This study's planned enrollment of 45 is below the median of 75 across 1,089 interventional studies indexed under Agnosia.
Browse Agnosia studies →Atlanta VA Medical Center is the lead sponsor of 16 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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.
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
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
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.
Time frame: 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.
Time frame: 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%.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1, immediately following the procedure
Procedural Pain Ratings
Three participant-rated items on 0-10 Numerical Rating Scales, each reported separately: (1) worst pain during the injection (0 = no pain at all, 10 = excruciating pain); (2) pain unpleasantness during the injection (0 = not unpleasant at all, 10 = excruciatingly unpleasant); (3) time spent thinking about pain during the injection (0 = none of the time, 10 = all of the time). Higher scores indicate worse outcomes on all three items. Reported by arm.
Time frame: Day 1, immediately following the procedure
Anxiety During the Procedure, Adjusted for Baseline
Participant-rated anxiety on a 0-10 Numerical Rating Scale (0 = not anxious or nervous at all, 10 = extremely anxious/nervous), measured at baseline (feeling prior to the injection) and post-procedure (feeling during the injection). Higher scores indicate greater anxiety. Procedural anxiety will be compared between arms with adjustment for baseline anxiety.
Time frame: Baseline (Day 1, after consent and before randomization) and Day 1 immediately following the procedure
Change in Cybersickness Symptoms From Baseline
Four participant-rated symptoms on 0-10 Numerical Rating Scales, each reported separately: nausea (0 = no nausea at all, 10 = vomit), dizziness/spinning sensations (0 = no dizziness at all, 10 = extreme dizziness), headache (0 = no headache at all, 10 = extreme headache), and eye strain (0 = no eye strain at all, 10 = extreme eye strain). Each is rated at baseline and post-procedure. Higher scores indicate worse symptoms. Change for each symptom is calculated as post-procedure minus baseline. Reported by arm.
Time frame: Baseline (Day 1, before randomization) and Day 1 immediately following the procedure
Perceived Procedure Experience
Three participant-rated items on 0-10 Numerical Rating Scales, each reported separately: (1) enjoyment during the injection (0 = no fun at all, 10 = extremely fun); (2) perceived speed of the procedure (0 = very slow, 5 = standard, 10 = very fast); (3) vividness of memory of the procedure (0 = no memory, 10 = indistinguishable or extremely vivid). Higher scores indicate more enjoyment, faster perceived speed, and more vivid memory, respectively. Reported by arm.
Time frame: Day 1, immediately following the procedure
Perceived Distraction by the Virtual Environment
Participant rating of how distracted they felt from the knee injection by the virtual world on a 0-10 Numerical Rating Scale (0 = not distracted at all, 10 = extremely distracted). Higher scores indicate greater distraction. VR + standard of care arm only.
Time frame: Day 1, immediately following the procedure
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared. Data will be analyzed and reported in aggregate only. Data are stored on a secured VA research drive and are subject to VA privacy and records management requirements. Aggregate results will be shared through peer-reviewed publication and scientific presentations.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Atlanta VA Medical Center