Virtual Reality Therapy for Pain Management During Medical Procedures

Overseen By Paulette Mensah, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

Disqualifiers: Sedation, Cognitive impairment, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 20 minutes

67 Participants Needed

Trial Summary

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 data supports the idea that Virtual Reality Therapy for Pain Management During Medical Procedures is an effective treatment?

The available research shows that Virtual Reality Therapy (VRT) is effective in reducing pain during medical procedures. One study found that VRT can distract patients from pain by immersing them in a 3D environment, making it a practical tool for pain management. Another review highlighted that VRT was particularly effective for reducing pain during burn injury care and experimental pain. Although results for needle-related pain were less consistent, more advanced VR technology that fully immerses users was linked to greater pain relief. Overall, these studies suggest that VRT is a promising option for managing pain compared to other treatments. ^{1 2 3 4 5}

What safety data exists for Virtual Reality Therapy for pain management?

The research indicates that Virtual Reality Therapy (VRT) has been studied in various contexts for pain management, including postoperative pain in children and adolescents, cancer-related medical procedures, and general pain reduction. Studies have shown that VRT, including distraction-based and guided relaxation-based VR, can effectively reduce pain and anxiety. However, specific safety data is not detailed in the provided abstracts. The studies focus on effectiveness and feasibility, suggesting that VRT is a promising non-pharmacological option for pain management, but more detailed safety evaluations may be needed. ^{5 6 7 8 9}

Is virtual reality therapy a promising treatment for pain management during medical procedures?

Yes, virtual reality therapy is a promising treatment for pain management. It helps distract patients from pain by immersing them in a 3D virtual world, which can reduce pain and discomfort. This approach has been effective in various settings, including during medical procedures, and offers a non-drug way to manage pain. ^{1 3 5 8 10}

What is the purpose of this trial?

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.

Research Team

Navid Alem, MD

Principal Investigator

Faculty

Eligibility Criteria

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: VR Intervention Experimental Treatment 1 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.

Group II: Control Active Control 1 Intervention

The control group will receive a genicular RFA with local anesthetic as per the standard-of-care

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+

Findings from Research

Virtual reality (VR) therapies have shown promise in effectively distracting patients from both acute and chronic pain, suggesting a new approach to pain management beyond traditional methods like opioids and physical therapy.

Clinical studies indicate that VR can be beneficial for various pain conditions, including fibromyalgia and phantom limb pain, by immersing patients in interactive environments that reduce their perception of pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality as a Clinical Tool for Pain Management. Pourmand, A., Davis, S., Marchak, A., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Virtual Reality Therapeutics for Acute Pain Management. Dreesmann, NJ., Su, H., Thompson, HJ.[2023]

A study involving 100 hospitalized patients showed that a one-time 3D virtual reality (VR) intervention significantly reduced pain more than a 2D distraction video, with an average pain reduction of -1.3 points compared to -0.6 points for the control group.

The VR intervention was not only effective, with 65% of patients experiencing a meaningful pain response, but it was also safe, as no adverse events were reported during the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality for Management of Pain in Hospitalized Patients: Results of a Controlled Trial. Tashjian, VC., Mosadeghi, S., Howard, AR., et al.[2020]

Virtual reality (VR) has been shown to effectively reduce acute pain across different age groups, with juvenile patients experiencing a greater reduction in pain intensity compared to adults.

While VR therapy significantly alleviates acute pain and reduces anxiety and other pain-related indicators, it does not improve pain tolerance and shows limited effectiveness for chronic pain conditions like low back pain and cancer-related pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Virtual Reality Exposure Therapy in Pain Management: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Huang, Q., Lin, J., Han, R., et al.[2022]

A review of 11 controlled studies indicates that virtual reality (VR) distraction is effective in reducing both experimental pain and discomfort during burn injury care.

More advanced VR technology that fully immerses users in a virtual environment tends to provide greater pain relief, suggesting that VR could be a valuable tool for clinicians managing various pain conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of virtual reality distraction for pain reduction: a systematic review. Malloy, KM., Milling, LS.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

This study is evaluating the effectiveness of guided relaxation-based virtual reality (VR-GR) compared to distraction-based VR (VR-D) and a passive control (360 video) in managing pain for 90 children and adolescents undergoing surgery, with a focus on pain intensity and related psychological factors.

The trial aims to determine if VR-GR can provide more lasting pain relief than traditional distraction methods, potentially reducing the need for opioid and benzodiazepine medications post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guided relaxation-based virtual reality versus distraction-based virtual reality or passive control for postoperative pain management in children and adolescents undergoing Nuss repair of pectus excavatum: protocol for a prospective, randomised, controlled trial (FOREVR Peds trial). Olbrecht, VA., Williams, SE., O'Conor, KT., et al.[2021]

In a study involving healthy volunteers aged 18-20, participants using High Tech virtual reality (VR) reported a stronger sense of immersion and significantly greater pain reduction compared to those using Low Tech VR, with reductions of 3.1 vs. 0.7 in worst pain ratings.

The effectiveness of VR in reducing pain was positively correlated with the level of immersion experienced, suggesting that enhancing the illusion of being in a virtual world can improve pain distraction during medical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manipulating presence influences the magnitude of virtual reality analgesia. Hoffman, HG., Sharar, SR., Coda, B., et al.[2008]

Virtual reality (VR) has been beneficial in managing acute pain in adults for over 20 years, showing promise in pain relief through various mechanisms, although results for chronic pain and pediatric populations are mixed.

Many studies on VR's effectiveness have limitations, such as small sample sizes and lack of control over variables, highlighting the need for larger, randomized controlled trials to clarify its most effective applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality and the Mediation of Acute and Chronic Pain in Adult and Pediatric Populations: Research Developments. Hadjiat, Y., Marchand, S.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Virtual Reality as a Clinical Tool for Pain Management. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review of Virtual Reality Therapeutics for Acute Pain Management. [2023]

3. Canada pubmed.ncbi.nlm.nih.gov

Virtual Reality for Management of Pain in Hospitalized Patients: Results of a Controlled Trial. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Using Virtual Reality Exposure Therapy in Pain Management: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The effectiveness of virtual reality distraction for pain reduction: a systematic review. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Dataset used to refine a treatment protocol of a biofeedback-based virtual reality intervention for pain and anxiety in children and adolescents undergoing surgery. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Effect of Virtual Reality Therapy in Reducing Pain and Anxiety for Cancer-Related Medical Procedures: A Systematic Narrative Review. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Guided relaxation-based virtual reality versus distraction-based virtual reality or passive control for postoperative pain management in children and adolescents undergoing Nuss repair of pectus excavatum: protocol for a prospective, randomised, controlled trial (FOREVR Peds trial). [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Manipulating presence influences the magnitude of virtual reality analgesia. [2008]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Virtual Reality and the Mediation of Acute and Chronic Pain in Adult and Pediatric Populations: Research Developments. [2022]