Trial Outcomes & Findings for Effect of VR on Pain and Patient Satisfaction in Adults Receiving GNRFA (NCT NCT05468398)

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.

Race and Ethnicity were not collected from any participant.

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 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.

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).

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.

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.

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).

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).

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).

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).

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.