Virtual Reality Therapy for Pain Management During Medical Procedures

NA
PM
Overseen ByPaulette Mensah, BA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Irvine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether virtual reality therapy (VRT) can reduce pain and improve satisfaction for patients undergoing genicular nerve radiofrequency ablation (GNRFA), a common treatment for knee pain. Participants will be divided into two groups: one using the Soothe VR device during the procedure and the other receiving standard care without VR. Ideal candidates for this trial have previously undergone nerve blocks or similar procedures and do not require sedation. As an unphased trial, this study provides patients the chance to explore innovative pain management techniques.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this virtual reality therapy is safe for pain management during medical procedures?

Research shows that virtual reality (VR) therapy is generally safe during medical procedures. Studies have found that immersive VR can effectively manage pain without major side effects. For instance, one study found that VR use significantly reduced pain and anxiety during procedures. Another study showed that patients using VR experienced less intense pain and spent less time focusing on it.

No reports of serious negative effects have emerged from using VR in these situations. This suggests that VR therapy, like the Soothe VR used in this trial, is well-tolerated by patients during medical procedures. Since this treatment is being tested in a study not seeking FDA approval, its safety aligns with its use in other medical settings.12345

Why are researchers excited about this trial?

Researchers are excited about Soothe VR for pain management because it offers a new, immersive way to help patients manage pain during medical procedures. Unlike traditional pain management methods, which often rely on medications like opioids or local anesthetics, Soothe VR uses virtual reality to distract and engage patients' minds, potentially reducing their pain perception without additional drugs. This innovative approach could lead to fewer side effects and less reliance on medication, making it a promising option for enhancing patient comfort and safety during procedures.

What evidence suggests that Soothe VR is effective for pain management during medical procedures?

Research shows that virtual reality (VR) can help reduce pain during medical procedures. Studies have found that people using VR experience less pain and stress. One study found that VR significantly lowered pain levels in patients receiving end-of-life care, while another study noted a reduction in pain and anxiety. Although VR might not increase pain tolerance, it consistently makes pain feel less intense. In this trial, participants in the VR Intervention group will use the Soothe VR device during Genicular nerve radiofrequency ablation (GNRFA), while the control group will receive the procedure with standard care. Overall, VR therapy appears promising for managing pain during medical procedures like GNRFA.13678

Who Is on the Research Team?

NA

Navid Alem, MD

Principal Investigator

Faculty

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are undergoing a genicular nerve radiofrequency ablation, including those with past nerve blocks or similar procedures. It's not suitable for pregnant women, individuals with infections requiring isolation, blindness, deafness, severe motion sickness or nausea/vomiting, refusal to use VR headsets, need for sedation during the procedure, cognitive impairments like dementia or recent stroke/epilepsy/psychosis/claustrophobia.

Inclusion Criteria

Patients aged 18 or older
You have recently undergone a procedure called genicular nerve radiofrequency ablation.
It is okay to participate if you have had nerve blocks or radiofrequency ablation procedures in the past.

Exclusion Criteria

Isolation status for infection control
Pregnancy (Pregnancy testing point of care available for females of child bearing age)
You are unable to see or hear.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo genicular nerve radiofrequency ablation (GNRFA) with or without virtual reality therapy (VRT) for pain management

20 minutes
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure, including assessment of pain, satisfaction, and side effects

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Soothe VR
Trial Overview The study is testing 'Soothe VR', a virtual reality therapy during GNRFA procedures to see if it reduces pain and increases patient satisfaction compared to standard care without VR.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: VR InterventionExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials
580
Recruited
4,943,000+

Applied VR

Collaborator

Trials
1
Recruited
70+

Published Research Related to This Trial

Virtual reality (VR) has been shown to be an effective tool for managing acute pain, with 83% of the studies reviewed reporting decreased pain intensity when using VR compared to non-VR methods.
The effectiveness of VR in pain management is likely due to its ability to distract patients, highlighting the importance of creating immersive and engaging VR experiences to enhance therapeutic outcomes.
A Systematic Review of Virtual Reality Therapeutics for Acute Pain Management.Dreesmann, NJ., Su, H., Thompson, HJ.[2023]
Biofeedback-based virtual reality (VR-BF) is a promising nonpharmacologic approach to pain management that could help reduce the need for opioids in children and adolescents after surgery, addressing the opioid epidemic's impact on this vulnerable population.
In a study involving 23 surgical patients, VR-BF was evaluated for its feasibility and acceptability, aiming to establish a treatment protocol that includes preoperative education and postoperative application to manage pain effectively.
Dataset used to refine a treatment protocol of a biofeedback-based virtual reality intervention for pain and anxiety in children and adolescents undergoing surgery.Orgil, Z., Karthic, A., Bell, N., et al.[2023]
A systematic review of nine studies on the use of immersive virtual reality (VR) for pain and anxiety management in cancer patients showed a trend towards improvement, but only two studies demonstrated statistically significant results.
The current evidence is inconclusive due to methodological limitations and small sample sizes, highlighting the need for further research to better understand the effectiveness of VR in this context.
Effect of Virtual Reality Therapy in Reducing Pain and Anxiety for Cancer-Related Medical Procedures: A Systematic Narrative Review.Chow, H., Hon, J., Chua, W., et al.[2021]

Citations

Efficacy of virtual reality for pain relief in medical proceduresImmersive VR technology offers effective pain control across various medical procedures, albeit statistical heterogeneity.
Virtual reality and pain management: current trends and future ...In clinical settings and experimental studies, participants immersed in VR experience reduced levels of pain, general distress/unpleasantness and report a ...
Efficacy of Virtual Reality in Managing Pain for Patients ...Results. The analysis of ten trials demonstrated VR's capability to significantly reduce pain intensity in palliative care. The pooled effect ...
Effectiveness of Virtual Reality in Reducing Perceived Pain ...Results: The study is already underway, and results support a decrease in perceived pain by 1.00 and a decrease in perceived anxiety by 0.3 ...
Using Virtual Reality Exposure Therapy in Pain ManagementVR can effectively alleviate acute pain. Nevertheless, VR showed little effectiveness in increasing pain tolerance, which may explain in part ...
Effects of Virtual Reality on Analgesia in Wound Care and ...The combined data revealed that the VR group experienced a significant reduction in worst pain intensity, pain unpleasantness intensity, and time spent thinking ...
Virtual reality for pain management: an umbrella reviewThis umbrella review demonstrates successful application of virtual reality in pain control, including perioperative, periprocedural, and chronic pain settings.
Effect of virtual reality (VR) therapy on pain sensation in ...Our results show that the use of virtual reality therapy during ultrasound-guided regional anesthesia placement and hand surgery does not result in lower pain ...
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