Trial Outcomes & Findings for Effect of VR on Pain and Patient Satisfaction in Adults Receiving GNRFA (NCT NCT05468398)
NCT ID: NCT05468398
Last Updated: 2025-07-04
Results Overview
Peak pain intensity experienced by participants during the genicular RFA procedure was assessed using a Graphic Rating Scale (GRS) from 0 (no pain) to 100 (worst imaginable pain). Higher scores indicate greater pain intensity (worse outcome).
COMPLETED
NA
40 participants
20 minutes
2025-07-04
Participant Flow
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.
Of the 40 participants who consented, all were randomized.
Participant milestones
| Measure |
Control
The control group will receive a genicular RFA with local anesthetic as per the standard-of-care
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
22
|
|
Overall Study
COMPLETED
|
18
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control
n=18 Participants
The control group will receive a genicular RFA with local anesthetic as per the standard-of-care
|
VR Intervention
n=22 Participants
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.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=18 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=18 Participants
|
12 Participants
n=22 Participants
|
21 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=18 Participants
|
10 Participants
n=22 Participants
|
19 Participants
n=40 Participants
|
|
Age, Continuous
|
66.3 years
STANDARD_DEVIATION 9.4 • n=18 Participants
|
65.2 years
STANDARD_DEVIATION 8.7 • n=22 Participants
|
65.7 years
STANDARD_DEVIATION 9.0 • n=40 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=18 Participants
|
14 Participants
n=22 Participants
|
25 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=18 Participants
|
8 Participants
n=22 Participants
|
15 Participants
n=40 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
18 participants
n=18 Participants
|
22 participants
n=22 Participants
|
40 participants
n=40 Participants
|
|
Baseline pain intensity was measured using the Visual Analog Scale (VAS)
|
66.3 units on a scale 0 - 100
STANDARD_DEVIATION 9.4 • n=18 Participants
|
65.2 units on a scale 0 - 100
STANDARD_DEVIATION 8.7 • n=22 Participants
|
65.7 units on a scale 0 - 100
STANDARD_DEVIATION 9.0 • n=40 Participants
|
PRIMARY outcome
Timeframe: 20 minutesPopulation: All participants who completed both the pre- and post-procedure pain assessments were included in this analysis (n=40). Pain score reduction was calculated as the difference between pre- and post-procedure VAS scores.
Peak pain intensity experienced by participants during the genicular RFA procedure was assessed using a Graphic Rating Scale (GRS) from 0 (no pain) to 100 (worst imaginable pain). Higher scores indicate greater pain intensity (worse outcome).
Outcome measures
| Measure |
Control
n=18 Participants
The control group will receive a genicular RFA with local anesthetic as per the standard-of-care
|
VR Intervention
n=22 Participants
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.
|
|---|---|---|
|
Peak Pain Intensity During Genicular RFA Procedure
|
78.17 units on a scale
Standard Deviation 18.25
|
68.17 units on a scale
Standard Deviation 24
|
PRIMARY outcome
Timeframe: Immediately post-genicular RFA procedure (approximately 20 minutes after procedure initiation)Population: Only participants in the VR group completed the satisfaction survey. All 22 participants in this group were included in the analysis.
Patient satisfaction with the Virtual Reality (VR) device during the genicular radiofrequency ablation (RFA) procedure was assessed using a Graphic Rating Scale (GRS). 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.
Outcome measures
| Measure |
Control
n=22 Participants
The control group will receive a genicular RFA with local anesthetic as per the standard-of-care
|
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.
|
|---|---|---|
|
Patient Satisfaction With VR Device
|
87.7 units on a 0 -100 scale
Standard Deviation 15.6
|
—
|
SECONDARY outcome
Timeframe: During the genicular RFA procedure (approximately 20 minutes)The duration or proportion of time patients spent thinking about their pain during the genicular radiofrequency ablation (RFA) procedure was assessed using a 0-100 Graphic Rating Scale (GRS). Participants rated how much time they spent thinking about pain during the procedure, with scores ranging from 0 ("no time thinking about pain") to 100 ("entire procedure spent thinking about pain"). Higher scores indicate a worse outcome (greater proportion of procedure time spent thinking about pain).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During the genicular RFA procedure (approximately 20 minutes)Population: All 40 participants (22 in the VR group, 18 in the control group) completed the anxiety question during the procedure and were included in this analysis. Anxiety was measured using a 0-100 Graphic Rating Scale, with higher scores indicating greater anxiety.
Patient anxiety during the genicular radiofrequency ablation (RFA) procedure was assessed using a 0-100 Graphic Rating Scale (GRS). 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).
Outcome measures
| Measure |
Control
n=18 Participants
The control group will receive a genicular RFA with local anesthetic as per the standard-of-care
|
VR Intervention
n=22 Participants
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.
|
|---|---|---|
|
Patient Anxiety During Genicular RFA Procedure Patient Anxiety During Genicular RFA Procedure Patient Anxiety During Genicular RFA Procedure
|
71.17 Units on a 0-100 scale
Standard Deviation 23.15
|
51.4 Units on a 0-100 scale
Standard Deviation 26.13
|
SECONDARY outcome
Timeframe: Immediately post-genicular RFA procedure (approximately 20 minutes after procedure initiation)Population: 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.
Practitioners' satisfaction with the Virtual Reality (VR) device during the genicular radiofrequency ablation (RFA) procedure was assessed using a 0-100 Graphic Rating Scale (GRS). 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.
Outcome measures
| Measure |
Control
n=18 Participants
The control group will receive a genicular RFA with local anesthetic as per the standard-of-care
|
VR Intervention
n=22 Participants
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.
|
|---|---|---|
|
Provider Satisfaction During Procedure
|
61.25 Units on a 0-100 scale
Standard Deviation 24
|
87.9 Units on a 0-100 scale
Standard Deviation 15.25
|
SECONDARY outcome
Timeframe: During the genicular RFA procedure (approximately 20 minutes)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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During the genicular RFA procedure (approximately 20 minutes)Population: Ratings were based on provider observation and recorded using a 0-100 Graphic rating Scale, where higher scores indicate greater perceived patient pain.
Provider's perception of the patient's pain during the genicular RFA procedure was assessed using a 0-100 Graphic Rating Scale (GRS). 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).
Outcome measures
| Measure |
Control
n=18 Participants
The control group will receive a genicular RFA with local anesthetic as per the standard-of-care
|
VR Intervention
n=22 Participants
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.
|
|---|---|---|
|
Provider Perception of Patient's Pain During Genicular RFA Procedure
|
71.11 Units on a 0-100 Scale
Standard Deviation 18.50
|
36.74 Units on a 0-100 Scale
Standard Deviation 21.67
|
SECONDARY outcome
Timeframe: Assessed at baseline (participant history of knee RFA within the past 2 years)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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed at baseline (participant history of VR use within the past 2 years)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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Immediately post-procedure (approximately 20 minutes after procedure initiation)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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed at baseline (demographic information collected at enrollment)A descriptive subgroup analysis of participants was conducted to identify commonalities in response and acceptance of technology across demographic characteristics including age, gender, provider type, and general acceptance of technology.
Outcome measures
Outcome data not reported
Adverse Events
Control
VR Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Navid Alem, MD / Principal Investigator
University of California, Irvine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place