An interventional study of Soothe VR in Pain and Patient Satisfaction, sponsored by University of California, Irvine. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by University of California, Irvine · Not applicable, Interventional, and Supportive care
The study team aims to investigate whether implementing virtual reality therapy (VRT) during Genicular nerve radiofrequency ablation (GNRFA) procedure will provide better alleviation of procedural pain and augmented satisfaction for patients.
Patients' experience through a medical procedure in a hospital environment is inherently stressful and painful. Although virtual reality (VR) was originally recognized for its entertainment value, it has recently been used as an innovative tool in clinical settings to reduce pain and anxiety, while improving patient satisfaction. VR is a computer generated simulation of a life-like experience that usually serves people for entertainment and social interactive purposes in a simulated three-dimensional environment. Virtual reality therapy (VRT) offers patients an opportunity to "get away" from noxious stimuli as they draw their attention towards another virtual world (Alem).
Virtual reality provides a cognitive distraction through creating a "real world illusion." VR may deter an individual's attention from pain as it offers a multimodal sensory distractor. This positive experience may result in reduction of pain score by decreasing the time patients think about their pain during a procedure.
Genicular nerve radiofrequency ablation (GNRFA) is an option to treat knee pain without surgery. The genicular nerves are the nerves that feed into the knee. Radiofrequency ablation is a process by applying radiofrequency waves to the nerves that are carrying the painful impulses from the knee joint. GNRFA uses fluoroscopy guidance to introduce 3 needles at each of the three genicular nerves which transmit sensation from the knee joint. This is followed by testing for sensory response, followed by administration of local anesthetic (2% lidocaine) per standard-of-care, and then radiofrequency ablation. This method of treatment is known to be very safe, convenient and reliable because fluoroscopy guidance provides high accuracy of localization at the procedure targets outside of the knee joint. Patients with symptomatic knee osteoarthritis have shown short and long term positive results following this method with significant reduction of pain levels (Kidd) and augmented functionality. This non-invasive procedure is able to successfully replace surgery or intra-articular therapy where the procedure is conducted directly on the knee joint.
2,226 studies on the registry are indexed under Pain; 917 are open to participants now.
This study's enrollment of 40 is below the median of 70 across 1,911 interventional studies indexed under Pain.
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Exclusion Criteria:
The control group will receive a genicular RFA with local anesthetic as per the standard-of-care
The VR Intervention group will receive a genicular RFA with local anesthetic as per the standard-of-care and the use of the Soothe VR device.
Device: Soothe VR
The Soothe VR system is manufactured by Applied VR. It is a HIPAA-compliant platform and has been validated by randomized control trials. It has not yet been reviewed by the FDA.
Peak Pain Intensity During Genicular RFA Procedure
Peak pain intensity experienced by participants during the genicular RFA procedure was assessed using a Visual Analog Scale (VAS) from 0 (no pain) to 100 (worst imaginable pain). Higher scores indicate greater pain intensity (worse outcome).
Time frame: 20 minutes
Patient Satisfaction With VR Device
Patient satisfaction with the Virtual Reality (VR) device during the genicular radiofrequency ablation (RFA) procedure was assessed using a Visual Analog Scale (VAS). Participants rated their overall satisfaction immediately following the procedure on a continuous scale ranging from 0 (not satisfied at all) to 100 (extremely satisfied). Higher scores indicate greater satisfaction, representing a better outcome.
Time frame: Immediately post-genicular RFA procedure (approximately 20 minutes after procedure initiation)
Patient Anxiety During Genicular RFA Procedure
Patient anxiety during the genicular radiofrequency ablation (RFA) procedure was assessed using a 0-100 VAS. Patients rated their anxiety level during the procedure only, from 0 ("not anxious at all") to 100 ("extremely anxious"). Higher scores indicate a worse outcome (greater anxiety).
Time frame: During the genicular RFA procedure (approximately 20 minutes)
Provider Satisfaction During Procedure
Practitioners' satisfaction with the Virtual Reality (VR) device during the genicular radiofrequency ablation (RFA) procedure was assessed using a 0-100 satisfaction VAS. Providers rated their overall satisfaction immediately following completion of the procedure, from 0 ("not satisfied at all") to 100 ("extremely satisfied"). Higher scores indicate greater satisfaction, representing a better outcome.
Time frame: Immediately post-genicular RFA procedure (approximately 20 minutes after procedure initiation)
Use of Additional Local Anesthetic During Genicular RFA Procedure
The need for additional local anesthetic administration during the genicular radiofrequency ablation (RFA) procedure was assessed as a binary outcome (Yes/No). Providers recorded whether additional local anesthetic was administered beyond the standard initial dose during the procedure.
Time frame: During the genicular RFA procedure (approximately 20 minutes)
Provider Perception of Patient's Pain During Genicular RFA Procedure
Provider's perception of the patient's pain during the genicular RFA procedure was assessed using a 0-100 VAS. Providers rated their perception of patient pain from 0 ("no perceived pain") to 100 ("extremely severe pain"). Higher scores indicate a worse outcome (higher perceived patient pain).
Time frame: During the genicular RFA procedure (approximately 20 minutes)
Prior Knee Radiofrequency Ablation
Participants were asked if they had undergone a previous knee radiofrequency ablation (RFA) procedure prior to the study intervention. Responses were recorded as binary outcomes (Yes/No).
Time frame: Assessed at baseline (participant history of knee RFA within the past 2 years)
Prior Experience With Virtual Reality (VR)
Participants reported if they had previously used Virtual Reality (VR) technology for any reason (e.g., gaming, therapy) before participation in the study. Responses were recorded as binary outcomes (Yes/No).
Time frame: Assessed at baseline (participant history of VR use within the past 2 years)
Side Effects Associated With Virtual Reality During Genicular RFA Procedure
Participants were asked immediately after the procedure if they experienced any side effects related to the use of Virtual Reality (VR), such as headache, dizziness, nausea, or palpitations. Responses were recorded as binary outcomes (Yes/No).
Time frame: Immediately post-procedure (approximately 20 minutes after procedure initiation)
Duration of Time Spent Thinking About Pain During Genicular RFA Procedure
This outcome was pre-specified in the study protocol but was not collected during the study due to an omission in data collection implementation. As a result, no data are available for this outcome, and it was not analyzed.
Time frame: During genicular RFA procedure (intra-procedural)
Participants were recruited at University of California, Irvine Health's Gottschalk Medical Plaza between December 2020 and September 2024. Due to study scope and completion of planned enrollment, the study closed with 40 enrolled participants.
| Milestone | Control | VR Intervention |
|---|---|---|
| Started | 20 | 20 |
| Completed | 20 | 20 |
| Not completed | 0 | 0 |
Peak pain intensity experienced by participants during the genicular RFA procedure was assessed using a Visual Analog Scale (VAS) from 0 (no pain) to 100 (worst imaginable pain). Higher scores indicate greater pain intensity (worse outcome).
| units on a scale | Control | VR Intervention |
|---|---|---|
| Peak Pain Intensity During Genicular RFA Procedure | 75.8 ± 21.9 | 70.6 ± 22 |
Patient satisfaction with the Virtual Reality (VR) device during the genicular radiofrequency ablation (RFA) procedure was assessed using a Visual Analog Scale (VAS). Participants rated their overall satisfaction immediately following the procedure on a continuous scale ranging from 0 (not satisfied at all) to 100 (extremely satisfied). Higher scores indicate greater satisfaction, representing a better outcome.
| units on a scale | VR Intervention |
|---|---|
| Patient Satisfaction With VR Device | 93.4 ± 11.5 |
Patient anxiety during the genicular radiofrequency ablation (RFA) procedure was assessed using a 0-100 VAS. Patients rated their anxiety level during the procedure only, from 0 ("not anxious at all") to 100 ("extremely anxious"). Higher scores indicate a worse outcome (greater anxiety).
| units on a scale | Control | VR Intervention |
|---|---|---|
| Patient Anxiety During Genicular RFA Procedure | 67.5 ± 26.6 | 55 ± 24.1 |
Practitioners' satisfaction with the Virtual Reality (VR) device during the genicular radiofrequency ablation (RFA) procedure was assessed using a 0-100 satisfaction VAS. Providers rated their overall satisfaction immediately following completion of the procedure, from 0 ("not satisfied at all") to 100 ("extremely satisfied"). Higher scores indicate greater satisfaction, representing a better outcome.
| units on a scale | Control | VR Intervention |
|---|---|---|
| Provider Satisfaction During Procedure | 60.8 ± 23.16 | 91.7 ± 23.7 |
The need for additional local anesthetic administration during the genicular radiofrequency ablation (RFA) procedure was assessed as a binary outcome (Yes/No). Providers recorded whether additional local anesthetic was administered beyond the standard initial dose during the procedure.
| Participants | Control | VR Intervention |
|---|---|---|
| Additional local anesthetic required | 5 | 3 |
| No additional local anesthetic required | 15 | 17 |
Provider's perception of the patient's pain during the genicular RFA procedure was assessed using a 0-100 VAS. Providers rated their perception of patient pain from 0 ("no perceived pain") to 100 ("extremely severe pain"). Higher scores indicate a worse outcome (higher perceived patient pain).
| units on a scale | Control | VR Intervention |
|---|---|---|
| Provider Perception of Patient's Pain During Genicular RFA Procedure | 70.8 ± 25.9 | 36.9 ± 25.2 |
Participants were asked if they had undergone a previous knee radiofrequency ablation (RFA) procedure prior to the study intervention. Responses were recorded as binary outcomes (Yes/No).
| Participants | Control | VR Intervention |
|---|---|---|
| Prior knee radiofrequency ablation | 0 | 0 |
| No Prior knee radiofrequency ablation | 20 | 20 |
Participants reported if they had previously used Virtual Reality (VR) technology for any reason (e.g., gaming, therapy) before participation in the study. Responses were recorded as binary outcomes (Yes/No).
| Participants | Control | VR Intervention |
|---|---|---|
| Prior experience with virtual reality | 5 | 5 |
| No prior experience with virtual reality | 15 | 15 |
Participants were asked immediately after the procedure if they experienced any side effects related to the use of Virtual Reality (VR), such as headache, dizziness, nausea, or palpitations. Responses were recorded as binary outcomes (Yes/No).
| Participants | Control | VR Intervention |
|---|---|---|
| Experienced VR-related side effects (Yes) | 0 | 0 |
| No VR-related side effects (No) | 20 | 20 |
This outcome was pre-specified in the study protocol but was not collected during the study due to an omission in data collection implementation. As a result, no data are available for this outcome, and it was not analyzed.
No measurements were reported for this outcome.
Collected over Participants were monitored continuously during and immediately following the genicular RFA procedure (approximately 20 minutes after procedure initiation).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| VR Intervention | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
All 40 participants (20 in the VR group, 20 in the control group) completed baseline surveys and were included in the baseline analysis. Each participant contributed one unit of analysis.
| Age, Categorical(Participants) | Control | VR Intervention | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 1 | 4 |
| >=65 years | 17 | 19 | 36 |
| Age, Continuous(years) | Control | VR Intervention | Total |
|---|---|---|---|
| Mean | 73.2 ± 5.2 | 70.6 ± 8.5 | 71.9 ± 7.1 |
| Sex: Female, Male(Participants) | Control | VR Intervention | Total |
|---|---|---|---|
| Female | 14 | 11 | 25 |
| Male | 6 | 9 | 15 |
| Race and Ethnicity Not Collected(Participants) | Control | VR Intervention | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Control | VR Intervention | Total |
|---|---|---|---|
| United States | 20 | 20 | 40 |
| Baseline pain intensity was measured using the Visual Analog Scale (VAS)(units on a scale) | Control | VR Intervention | Total |
|---|---|---|---|
| Mean | 71.8 ± 23.04 | 64.4 ± 23.5 | 67.7 ± 22.5 |
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University of California, Irvine