N/A N=40 Randomized Supportive Care

Effect of VR on Pain and Patient Satisfaction in Adults Receiving GNRFA

Pain · Patient Satisfaction

Bottom Line

View on ClinicalTrials.gov: NCT05468398 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2025

Primary outcome: Primary: Peak Pain Intensity During Genicular RFA Procedure — 75.8; 70.6 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Soothe VR (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of California, Irvine
Primary completion: Sep 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Peak Pain Intensity During Genicular RFA Procedure	75.8; 70.6	—
PRIMARY Patient Satisfaction With VR Device	93.4	—
SECONDARY Patient Anxiety During Genicular RFA Procedure	67.5; 55	—
SECONDARY Provider Satisfaction During Procedure	60.8; 91.7	—
SECONDARY Use of Additional Local Anesthetic During Genicular RFA Procedure	5; 3; 15; 17	—
SECONDARY Provider Perception of Patient's Pain During Genicular RFA Procedure	70.8; 36.9	—
SECONDARY Prior Knee Radiofrequency Ablation	0; 0; 20; 20	—
SECONDARY Prior Experience With Virtual Reality (VR)	5; 5; 15; 15	—
SECONDARY Side Effects Associated With Virtual Reality During Genicular RFA Procedure	0; 0; 20; 20	—
SECONDARY Duration of Time Spent Thinking About Pain During Genicular RFA Procedure	—	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05468398). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.