Pain ManagementNCT07884851
Testing the Timing and Application of Virtual Reality Distraction During Knee Injections in a VA Pain Clinic
A study testing Immersive Virtual Reality in people with Pain Management and Injection Pain Prevention, run by Atlanta VA Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Management, Injection Pain Prevention, Virtual Reality
- What is being tested?
- Immersive Virtual Reality
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Theory to Application: Workflow Feasibility of Virtual Reality Sedation in a VA Pain Clinic
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
Read more
- 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.
Read the detailed description
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.
- Conditions
- Pain Management, Injection Pain Prevention, Virtual Reality, Feasibility Studies, Distraction, Immersive Virtual Reality
- Being tested
- Immersive Virtual Reality
- Keywords
- virtual reality, injection, veterans, workflow, pain management, acute procedural pain
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Virtual RealityDevice
Also called SustainVR, VR
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Immersive Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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%.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1, immediately following the procedure
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1, immediately following the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atlanta VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Mercy Udoji, MD, Atlanta VA Medical Center
- Investigators
- Mercy L Udoji, MD, Principal investigator, Atlanta VA Medical Center, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884851
- Sponsor's protocol ID
- 2026P001360
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 7145389Krishnamurthy 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.
PubMed 34481599Hoffman 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.
PubMed 21264690Lier 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.
PubMed 36943251Teh 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.
PubMed 38355563
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Theory to Application: Workflow Feasibility of Virtual Reality Sedation in a VA Pain Clinic
- ClinicalTrials.gov ID
- NCT07884851
- Acronym / sponsor ID
- 2026P001360
- Conditions
- Pain Management, Injection Pain Prevention, Virtual Reality, Feasibility Studies, Distraction, Immersive Virtual Reality
- Keywords
- virtual reality, injection, veterans, workflow, pain management, acute procedural pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Atlanta VA Medical CenterUS federal agency
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 21 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Immersive Virtual RealityParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immersive Virtual RealityAlso: SustainVR, VRCommercially 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. | Device | VR Plus Standard of Care |
Primary outcome
Enrollment Rate
Time frame: Throughout the enrollment period (approximately 8 weeks)
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.
Virtual Reality Setup Time
Time frame: Day 1, from headset placement (after the pre-procedure timeout) to VR engagement, before needle insertion
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.
Virtual Reality Discontinuation Rate
Time frame: Day 1, from headset placement through needle withdrawal
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%.
Total Procedure Duration
Time frame: Day 1, from signing of procedure consent to dressing application
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.
Patient Satisfaction With the Procedure
Time frame: Day 1, immediately following 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.
Provider-Reported Workflow Disruption
Time frame: Day 1, immediately following the procedure
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.
Provider-Reported Patient Comfort
Time frame: Day 1, immediately following the procedure
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.
Willingness to Use Virtual Reality Again
Time frame: Day 1, immediately following the procedure
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.
5 secondary outcomes
Procedural Pain Ratings
Time frame: Day 1, immediately following the procedure
Anxiety During the Procedure, Adjusted for Baseline
Time frame: Baseline (Day 1, after consent and before randomization) and Day 1 immediately following the procedure
Change in Cybersickness Symptoms From Baseline
Time frame: Baseline (Day 1, before randomization) and Day 1 immediately following the procedure
Perceived Procedure Experience
Time frame: Day 1, immediately following the procedure
Perceived Distraction by the Virtual Environment
Time frame: Day 1, immediately following the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 7145389Nemesanszky 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.
- Background: PubMed 34481599Krishnamurthy 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.
- Background: PubMed 21264690Hoffman 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.
- Background: PubMed 36943251Lier 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.
- Background: PubMed 38355563Teh 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.
- VA Diffusion Marketplace: Re-engaging Veterans in Pain Through Immersive TechnologyLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mercy L Udoji, MD principal investigator
Atlanta VA Medical Center, Department of Anesthesiology
Questions about this trial
What is this clinical trial studying?
A study testing Immersive Virtual Reality in people with Pain Management and Injection Pain Prevention, run by Atlanta VA Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mercy Udoji, MD (404-297-1540, Mercy.Udoji@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment Rate (time frame: Throughout the enrollment period (approximately 8 weeks)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07884851, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.