PainNCT05468398
Effect of VR on Pain and Patient Satisfaction in Adults Receiving GNRFA
A study testing Soothe VR in people with Pain and Patient Satisfaction, run by University of California, Irvine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Patient Satisfaction
- What is being tested?
- Soothe VR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2020to 14 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18 or older
- Patients Undergoing a genicular nerve radiofrequency ablation
- Patients who have previously received nerve blocks or radiofrequency ablation procedures may be included
Who cannot join
- Requiring sedation during procedure
- Cognitive impairment or dementia
- History of recent stroke, epilepsy, psychosis, or claustrophobia
- Blindness or deafness
- Refusal to use the headset
- Isolation status for infection control
- Motion sickness or active nausea/vomit
- Pregnancy (Pregnancy testing point of care available for females of child bearing age)
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Irvine Gottschalk Medical Plaza
Irvine, California, 92617
About this study
Official title: The Effect of Virtual Reality on Pain and Patient Satisfaction in Adults Receiving Genicular Nerve Radiofrequency Ablation
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.
Read the detailed description
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.
- Conditions
- Pain, Patient Satisfaction
- Being tested
- Soothe VR
- Keywords
- Genicular Nerve Block, Virtual Reality, Genicular Nerve Radiofrequency Ablation, GNRFA
- Medical subject headings
- Pain, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soothe VRDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The control group will receive a genicular RFA with local anesthetic as per the standard-of-care |
| VR Intervention | Experimental | 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. Receives: Device: Soothe VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Immediately post-genicular RFA procedure (approximately 20 minutes after procedure initiation)
Secondary outcomes (8)
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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: During genicular RFA procedure (intra-procedural)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start2 Dec 2020
- Primary completion6 Sep 2024
- Study completion14 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This was a single-center, non-blinded, randomized controlled trial with a parallel assignment design. Participants were randomly allocated in a 1:1 ratio to receive either standard care alone or standard care with immersive virtual reality (VR) therapy during genicular nerve radiofrequency ablation (GNRFA). The intervention was administered during the procedure only. The study aimed to assess the impact of VR on patient-reported pain, anxiety, satisfaction, and physician-rated procedural outcomes.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Applied VR
- Responsible party
- Principal investigator, Navid Alem, University of California, Irvine
- Investigators
- Navid Alem, MD, Principal investigator, Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468398
- Sponsor's protocol ID
- 20206207
- Status last verified
- May 2026
- First submitted
- 18 Feb 2022
- Last updated
- 22 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Alaterre C, Duceau B, Sung Tsai E, Zriouel S, Bonnet F, Lescot T, Verdonk F. Virtual Reality for PEripheral Regional Anesthesia (VR-PERLA Study). J Clin Med. 2020 Jan 13;9(1):215. doi: 10.3390/jcm9010215.
PubMed 31941129Kidd VD, Strum SR, Strum DS, Shah J. Genicular Nerve Radiofrequency Ablation for Painful Knee Arthritis: The Why and the How. JBJS Essent Surg Tech. 2019 Mar 13;9(1):e10. doi: 10.2106/JBJS.ST.18.00016. eCollection 2019 Mar 26.
PubMed 31333900Jamison DE, Cohen SP. Radiofrequency techniques to treat chronic knee pain: a comprehensive review of anatomy, effectiveness, treatment parameters, and patient selection. J Pain Res. 2018 Sep 18;11:1879-1888. doi: 10.2147/JPR.S144633. eCollection 2018.
PubMed 30271194Hong T, Wang H, Li G, Yao P, Ding Y. Systematic Review and Meta-Analysis of 12 Randomized Controlled Trials Evaluating the Efficacy of Invasive Radiofrequency Treatment for Knee Pain and Function. Biomed Res Int. 2019 Jun 26;2019:9037510. doi: 10.1155/2019/9037510. eCollection 2019.
PubMed 31346525Chan PY, Scharf S. Virtual Reality as an Adjunctive Nonpharmacological Sedative During Orthopedic Surgery Under Regional Anesthesia: A Pilot and Feasibility Study. Anesth Analg. 2017 Oct;125(4):1200-1202. doi: 10.1213/ANE.0000000000002169.
PubMed 28598921McCaul KD, Malott JM. Distraction and coping with pain. Psychol Bull. 1984 May;95(3):516-33. No abstract available.
PubMed 6399756Mahrer NE, Gold JI. The use of virtual reality for pain control: a review. Curr Pain Headache Rep. 2009 Apr;13(2):100-9. doi: 10.1007/s11916-009-0019-8.
PubMed 19272275Hoffman HG, Seibel EJ, Richards TL, Furness TA, Patterson DR, Sharar SR. Virtual reality helmet display quality influences the magnitude of virtual reality analgesia. J Pain. 2006 Nov;7(11):843-50. doi: 10.1016/j.jpain.2006.04.006.
PubMed 17074626Mosso JL, Gorini A, De La Cerda G, Obrador T, Almazan A, Mosso D, Nieto JJ, Riva G. Virtual reality on mobile phones to reduce anxiety in outpatient surgery. Stud Health Technol Inform. 2009;142:195-200.
PubMed 19377147Carrougher GJ, Hoffman HG, Nakamura D, Lezotte D, Soltani M, Leahy L, Engrav LH, Patterson DR. The effect of virtual reality on pain and range of motion in adults with burn injuries. J Burn Care Res. 2009 Sep-Oct;30(5):785-91. doi: 10.1097/BCR.0b013e3181b485d3.
PubMed 19692911Sharar SR, Carrougher GJ, Nakamura D, Hoffman HG, Blough DK, Patterson DR. Factors influencing the efficacy of virtual reality distraction analgesia during postburn physical therapy: preliminary results from 3 ongoing studies. Arch Phys Med Rehabil. 2007 Dec;88(12 Suppl 2):S43-9. doi: 10.1016/j.apmr.2007.09.004.
PubMed 18036981Spiegel B, Fuller G, Lopez M, Dupuy T, Noah B, Howard A, Albert M, Tashjian V, Lam R, Ahn J, Dailey F, Rosen BT, Vrahas M, Little M, Garlich J, Dzubur E, IsHak W, Danovitch I. Virtual reality for management of pain in hospitalized patients: A randomized comparative effectiveness trial. PLoS One. 2019 Aug 14;14(8):e0219115. doi: 10.1371/journal.pone.0219115. eCollection 2019.
PubMed 31412029Sikka N, Shu L, Ritchie B, Amdur RL, Pourmand A. Virtual Reality-Assisted Pain, Anxiety, and Anger Management in the Emergency Department. Telemed J E Health. 2019 Dec;25(12):1207-1215. doi: 10.1089/tmj.2018.0273. Epub 2019 Feb 20.
PubMed 30785860Gold JI, Mahrer NE. Is Virtual Reality Ready for Prime Time in the Medical Space? A Randomized Control Trial of Pediatric Virtual Reality for Acute Procedural Pain Management. J Pediatr Psychol. 2018 Apr 1;43(3):266-275. doi: 10.1093/jpepsy/jsx129.
PubMed 29053848
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality on Pain and Patient Satisfaction in Adults Receiving Genicular Nerve Radiofrequency Ablation
- ClinicalTrials.gov ID
- NCT05468398
- Acronym / sponsor ID
- 20206207
- Conditions
- Pain, Patient Satisfaction
- Keywords
- Genicular Nerve Block, Virtual Reality, Genicular Nerve Radiofrequency Ablation, GNRFA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Applied VR
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 6 Sep 2024 (actual)
- Study completion
- 14 Dec 2024 (actual)
- First posted
- 21 Jul 2022 (actual)
- Results
- Posted 4 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This was a single-center, non-blinded, randomized controlled trial with a parallel assignment design. Participants were randomly allocated in a 1:1 ratio to receive either standard care alone or standard care with immersive virtual reality (VR) therapy during genicular nerve radiofrequency ablation (GNRFA). The intervention was administered during the procedure only. The study aimed to assess the impact of VR on patient-reported pain, anxiety, satisfaction, and physician-rated procedural outcomes.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control group will receive a genicular RFA with local anesthetic as per the standard-of-care |
| VR Intervention | Experimental | Device: Soothe VRThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 or older
- Patients Undergoing a genicular nerve radiofrequency ablation
- Patients who have previously received nerve blocks or radiofrequency ablation procedures may be included
Key exclusion criteria (8 listed)
- Requiring sedation during procedure
- Cognitive impairment or dementia
- History of recent stroke, epilepsy, psychosis, or claustrophobia
- Blindness or deafness
- Refusal to use the headset
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 |
|---|---|---|
| Soothe VRThe 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. | Device | VR Intervention |
Primary outcome
Peak Pain Intensity During Genicular RFA Procedure
Time frame: 20 minutes
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).
Patient Satisfaction With VR Device
Time frame: Immediately post-genicular RFA procedure (approximately 20 minutes after procedure initiation)
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.
8 secondary outcomes
Patient Anxiety During Genicular RFA Procedure
Time frame: During the genicular RFA procedure (approximately 20 minutes)
Provider Satisfaction During Procedure
Time frame: Immediately post-genicular RFA procedure (approximately 20 minutes after procedure initiation)
Use of Additional Local Anesthetic During Genicular RFA Procedure
Time frame: During the genicular RFA procedure (approximately 20 minutes)
Provider Perception of Patient's Pain During Genicular RFA Procedure
Time frame: During the genicular RFA procedure (approximately 20 minutes)
Prior Knee Radiofrequency Ablation
Time frame: Assessed at baseline (participant history of knee RFA within the past 2 years)
Prior Experience With Virtual Reality (VR)
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
Time frame: Immediately post-procedure (approximately 20 minutes after procedure initiation)
Duration of Time Spent Thinking About Pain During Genicular RFA Procedure
Time frame: During genicular RFA procedure (intra-procedural)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31941129Alaterre C, Duceau B, Sung Tsai E, Zriouel S, Bonnet F, Lescot T, Verdonk F. Virtual Reality for PEripheral Regional Anesthesia (VR-PERLA Study). J Clin Med. 2020 Jan 13;9(1):215. doi: 10.3390/jcm9010215.
- Background: PubMed 31333900Kidd VD, Strum SR, Strum DS, Shah J. Genicular Nerve Radiofrequency Ablation for Painful Knee Arthritis: The Why and the How. JBJS Essent Surg Tech. 2019 Mar 13;9(1):e10. doi: 10.2106/JBJS.ST.18.00016. eCollection 2019 Mar 26.
- Background: PubMed 30271194Jamison DE, Cohen SP. Radiofrequency techniques to treat chronic knee pain: a comprehensive review of anatomy, effectiveness, treatment parameters, and patient selection. J Pain Res. 2018 Sep 18;11:1879-1888. doi: 10.2147/JPR.S144633. eCollection 2018.
- Background: PubMed 31346525Hong T, Wang H, Li G, Yao P, Ding Y. Systematic Review and Meta-Analysis of 12 Randomized Controlled Trials Evaluating the Efficacy of Invasive Radiofrequency Treatment for Knee Pain and Function. Biomed Res Int. 2019 Jun 26;2019:9037510. doi: 10.1155/2019/9037510. eCollection 2019.
- Background: PubMed 28598921Chan PY, Scharf S. Virtual Reality as an Adjunctive Nonpharmacological Sedative During Orthopedic Surgery Under Regional Anesthesia: A Pilot and Feasibility Study. Anesth Analg. 2017 Oct;125(4):1200-1202. doi: 10.1213/ANE.0000000000002169.
- Background: PubMed 6399756McCaul KD, Malott JM. Distraction and coping with pain. Psychol Bull. 1984 May;95(3):516-33. No abstract available.
- Background: PubMed 19272275Mahrer NE, Gold JI. The use of virtual reality for pain control: a review. Curr Pain Headache Rep. 2009 Apr;13(2):100-9. doi: 10.1007/s11916-009-0019-8.
- Background: PubMed 17074626Hoffman HG, Seibel EJ, Richards TL, Furness TA, Patterson DR, Sharar SR. Virtual reality helmet display quality influences the magnitude of virtual reality analgesia. J Pain. 2006 Nov;7(11):843-50. doi: 10.1016/j.jpain.2006.04.006.
- Background: PubMed 19377147Mosso JL, Gorini A, De La Cerda G, Obrador T, Almazan A, Mosso D, Nieto JJ, Riva G. Virtual reality on mobile phones to reduce anxiety in outpatient surgery. Stud Health Technol Inform. 2009;142:195-200.
- Background: PubMed 19692911Carrougher GJ, Hoffman HG, Nakamura D, Lezotte D, Soltani M, Leahy L, Engrav LH, Patterson DR. The effect of virtual reality on pain and range of motion in adults with burn injuries. J Burn Care Res. 2009 Sep-Oct;30(5):785-91. doi: 10.1097/BCR.0b013e3181b485d3.
- Background: PubMed 18036981Sharar SR, Carrougher GJ, Nakamura D, Hoffman HG, Blough DK, Patterson DR. Factors influencing the efficacy of virtual reality distraction analgesia during postburn physical therapy: preliminary results from 3 ongoing studies. Arch Phys Med Rehabil. 2007 Dec;88(12 Suppl 2):S43-9. doi: 10.1016/j.apmr.2007.09.004.
- Background: PubMed 31412029Spiegel B, Fuller G, Lopez M, Dupuy T, Noah B, Howard A, Albert M, Tashjian V, Lam R, Ahn J, Dailey F, Rosen BT, Vrahas M, Little M, Garlich J, Dzubur E, IsHak W, Danovitch I. Virtual reality for management of pain in hospitalized patients: A randomized comparative effectiveness trial. PLoS One. 2019 Aug 14;14(8):e0219115. doi: 10.1371/journal.pone.0219115. eCollection 2019.
- Applied VR Research StudiesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Navid Alem, MD principal investigator
Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soothe VR in people with Pain and Patient Satisfaction, run by University of California, Irvine at 1 site in United States.
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: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 4 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Pain Intensity During Genicular RFA Procedure (time frame: 20 minutes). The study lists 2 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 NCT05468398, which also lists 14 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 22 May 2026.