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| Name | Class |
|---|---|
| Applied VR | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soothe VR | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | Immediately post-genicular RFA procedure (approximately 20 minutes after procedure initiation) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | During the genicular RFA procedure (approximately 20 minutes) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Navid Alem, MD | Faculty | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Irvine Gottschalk Medical Plaza | Irvine | California | 92617 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31941129 | Background | 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. | |
| 31333900 | Background | Kidd 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. |
| Label | URL |
|---|---|
| Applied VR Research Studies | View source |
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Of the 40 participants who consented, all were randomized.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | The control group will receive a genicular RFA with local anesthetic as per the standard-of-care |
| FG001 | VR Intervention | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | The control group will receive a genicular RFA with local anesthetic as per the standard-of-care |
| BG001 | VR Intervention | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | All enrolled participants with available baseline data were included in the baseline analysis. Each participant contributed one unit of analysis. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | All randomized participants who reported peak pain intensity during the genicular RFA procedure were included in this analysis (n=40). Each participant contributed one measurement of peak procedural pain intensity. | Posted | Mean | Standard Deviation | units on a scale | 20 minutes |
|
Participants were monitored continuously during and immediately following the genicular RFA procedure (approximately 20 minutes after procedure initiation).
Participants were continuously observed by clinical personnel for any adverse events (serious or non-serious) during and immediately following the genicular RFA procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | The control group will receive a genicular RFA with local anesthetic as per the standard-of-care |
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This was a single-site, randomized but non-blinded pilot study with a relatively small sample size, which may limit generalizability. Participants and providers were aware of group assignments when the VR device was applied. Self-reported measures and a study pause due to COVID-19 may have impacted data consistency.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Navid Alem, MD / Principal Investigator | University of California, Irvine | (949) 413-4950 | alemn@hs.uci.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 23, 2025 | Jun 17, 2025 | Prot_SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 15, 2020 | Apr 24, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000074822 | Treatment Adherence and Compliance |
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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.
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| 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. | 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. | 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). | 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). | 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). | 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). | 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. | During genicular RFA procedure (intra-procedural) |
| 30271194 | Background | Jamison 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. |
| 31346525 | Background | Hong 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. |
| 28598921 | Background | Chan 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. |
| 6399756 | Background | McCaul KD, Malott JM. Distraction and coping with pain. Psychol Bull. 1984 May;95(3):516-33. No abstract available. |
| 19272275 | Background | Mahrer 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. |
| 17074626 | Background | Hoffman 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. |
| 19377147 | Background | Mosso 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. |
| 19692911 | Background | Carrougher 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. |
| 18036981 | Background | Sharar 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. |
| 31412029 | Background | Spiegel 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. |
| 30785860 | Background | Sikka 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. |
| 29053848 | Background | Gold 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. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | All enrolled participants with available baseline data were included in the baseline analysis. Each participant contributed one unit of analysis. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| Baseline pain intensity was measured using the Visual Analog Scale (VAS) | The VAS assesses the participant's perceived pain level on a continuous scale ranging from 0 (no pain) to 100 (worst imaginable pain). Higher scores indicate worse pain. | Mean | Standard Deviation | units on a scale |
|
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. 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. |
|
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| Primary | 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. | This outcome was assessed only among participants randomized to the VR intervention group, as satisfaction with the VR device was not applicable to control participants. All 20 VR participants provided one post-procedure satisfaction rating and were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Immediately post-genicular RFA procedure (approximately 20 minutes after procedure initiation) |
|
|
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| Secondary | 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). | All 40 participants (20 in the VR group, 20 in the control group) completed the anxiety question during the procedure and were included in this analysis. Anxiety was measured using a 0-100 Visual Analog Scale (VAS), with higher scores indicating greater anxiety. | Posted | Mean | Standard Deviation | units on a scale | During the genicular RFA procedure (approximately 20 minutes) |
|
|
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| Secondary | 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. | Practitioners rated their satisfaction with the procedure using a 0-100 Graphic Rating Scale. Higher scores indicate greater satisfaction. Surveys were completed after each procedure based on the provider's experience with patient behavior and ease of the procedure. | Posted | Mean | Standard Deviation | units on a scale | Immediately post-genicular RFA procedure (approximately 20 minutes after procedure initiation) |
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| Secondary | 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. | Posted | Count of Participants | Participants | During the genicular RFA procedure (approximately 20 minutes) |
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| Secondary | 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). | Ratings were based on provider observation and recorded using a 0-100 Graphic rating Scale, where higher scores indicate greater perceived patient pain. | Posted | Mean | Standard Deviation | units on a scale | During the genicular RFA procedure (approximately 20 minutes) |
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| Secondary | 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). | All participants included in this analysis are the same as those reported in the Participant Flow. | Posted | Count of Participants | Participants | Assessed at baseline (participant history of knee RFA within the past 2 years) |
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| Secondary | 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). | All participants included in this analysis are the same as those reported in the Participant Flow. | Posted | Count of Participants | Participants | Assessed at baseline (participant history of VR use within the past 2 years) |
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|
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| Secondary | 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). | All participants included in this analysis are the same as those reported in the Participant Flow. No participants were excluded from the analysis of VR-related side effects. | Posted | Count of Participants | Participants | Immediately post-procedure (approximately 20 minutes after procedure initiation) |
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| Secondary | 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. | This outcome was included in the pre-specified study protocol; however, it was not incorporated into the final data collection instruments used during study implementation. Therefore, no data were collected or analyzed for this outcome. | Posted | Mean | Standard Deviation | Not collected | During genicular RFA procedure (intra-procedural) |
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | VR Intervention | 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. 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. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D015438 | Health Behavior |
| D001519 | Behavior |