The Effect of Virtual Reality on Pain and Patient Satisfaction in Adults Receiving Genicular Nerve Radiofrequency Ablation
Phase: NA
Conditions: Pain, Patient Satisfaction
Sponsor: University of California, Irvine

 
 
 
 
 
 
 
 
Official Study Title: The Effect of Virtual Reality on Pain and Patient 
Satisfaction in Adults Receiving Genicular Nerve Radiofrequency Ablation 
 
NCT Number: NCT05468398 
Date: April 23, 2025 

Study Protocol 
Study Title 
The Effect of Virtual Reality on Pain and Anxiety in Adults Receiving Genicular Nerve 
Radiofrequency Ablation 
Principal Investigator 
Dr. Navid Alem, MD 
Department of Anesthesia and Perioperative Care 
University of California, Irvine 
Email: alemn@hs.uci.edu 
Phone: (949) 413-4950 
Sponsor 
University of California, Irvine 
1. Background and Rationale 
This study aimed to investigate whether Virtual Reality (VR) therapy could reduce 
procedural pain and anxiety in adults undergoing genicular nerve radiofrequency ablation 
(GNRFA). The study utilized the SootheVR system, a medically curated immersive VR 
device, during the procedure. VR therapy has emerged as a promising non-pharmacologic 
adjunct for managing procedural discomfort and anxiety. 
2. Study Objectives 
Primary Objective: 
- To evaluate the effect of VR therapy on post-procedural pain levels using the Visual Analog 
Scale (VAS). 
 
Secondary Objectives: 
- To assess pre- and post-procedure anxiety scores. 
- To measure patient satisfaction with the procedure. 
- To assess provider satisfaction and perception of patient pain. 
- To determine the use of additional local anesthetic. 

3. Study Design 
This was a randomized, non-blinded, single-site interventional study. Participants 
undergoing GNRFA were randomized to either receive standard care alone or standard care 
plus VR therapy using the SootheVR headset. Surveys were administered before and after 
the procedure to collect pain, anxiety, and satisfaction scores. Data were entered via 
Qualtrics. 
4. Eligibility Criteria 
Inclusion Criteria: 
- Adults ≥18 years 
- Undergoing genicular nerve radiofrequency ablation 
- Ability to consent 
 
Exclusion Criteria: 
- Need for sedation during procedure 
- Cognitive impairment 
- Neurological contraindications (e.g., epilepsy) 
- Refusal or intolerance to VR headset 
- Pregnancy 
- Motion sickness, visual/auditory impairments affecting headset use 
5. Study Procedures 
Participants were screened and consented on the day of the procedure. Baseline pain, 
anxiety, and prior VR experience were recorded via survey. Participants were then 
randomized to either VR or control group. Standard GNRFA was performed using 
fluoroscopy guidance. The VR group used the SootheVR headset during the procedure. Post-
procedure, surveys captured outcome data including pain, anxiety, and satisfaction metrics. 
6. Statistical Analysis Plan 
Data were analyzed using descriptive statistics and comparative tests. Paired t-tests or 
Wilcoxon signed-rank tests were used to evaluate changes in pain and anxiety scores. Group 
comparisons were conducted using independent t-tests or Mann-Whitney U tests where 
applicable. Significance was set at p < 0.05. 
7. Data Management 
Data were entered into Qualtrics and exported to secure institutional drives for analysis. No 
protected health information was stored outside of secure UCI systems. Only authorized 
personnel had access to the data. Surveys and raw data were retained for IRB compliance 
and results reporting. 

8. Ethics and Oversight 
This study was reviewed and approved by the University of California, Irvine Institutional 
Review Board (IRB #2020-6207). All participants gave informed consent. Data 
confidentiality was maintained throughout the study. The study was minimal risk and 
included monitoring for adverse reactions to VR technology. 
9. Study Status 
The study has been completed. Enrollment and data collection are finalized. Results analysis 
is underway and will be submitted to ClinicalTrials.gov.