Virtual Reality Game for Procedural Pain and Anxiety

Overseen By Henry Xiang, MD, MPH, PhD, MBA

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Nationwide Children's Hospital

Disqualifiers: Vision, hearing, cognitive impairments, others

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

Compensation: Varies

Number of Visits: 2

Duration: 2 sessions

40 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will assess the feasibility and efficacy of our Virtual Reality Pain Alleviation Therapy (VR-PAT) for pain management during pediatric and young adult outpatient laser procedures and evaluate the impact of VR use on reducing anxiety in patients undergoing dermatologic laser procedures. The investigators hypothesize that patients using VR-PAT will report less pain and anxiety during the laser procedure than patients who do not play the game.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators or your doctor for guidance.

What data supports the effectiveness of the treatment VR-PAT for reducing procedural pain and anxiety?

Research shows that using virtual reality (VR) during medical procedures can help reduce anxiety and pain. In a review of 16 studies, most found that VR improved patient experiences by lowering anxiety and pain levels during procedures. This suggests that VR-PAT could be effective for similar purposes. ^{1 2 3 4 5}

Is virtual reality safe for reducing pain and anxiety during medical procedures?

Research shows that using virtual reality (VR) during medical procedures is generally safe for both children and adults. Studies have found that VR can help reduce anxiety and pain without significant adverse effects, making it a promising tool for improving patient comfort during procedures. ^{1 2 6 7 8}

How does the virtual reality treatment for procedural pain and anxiety differ from other treatments?

This virtual reality treatment is unique because it uses immersive environments to distract and relax patients, potentially increasing pain tolerance and reducing anxiety without medication. Unlike traditional pain management methods, it targets cognitive and emotional processes, offering a non-drug, low-risk option that can improve mood and reduce pain perception. ^{9 10 11 12 13}

Research Team

Henry Xiang, MD, MPH, PhD, MBA

Principal Investigator

Nationwide Children's Hospital

Eligibility Criteria

This trial is for dermatology patients aged 5 and older who are about to have their first laser procedure at Nationwide Children's Outpatient Laser. They must be able to speak and have a guardian if under 18. It's not for those with wounds affecting the study, vision/hearing issues, history of motion sickness or migraines from visual effects, non-English speakers, pregnant women, prisoners, or minors in foster care.

Inclusion Criteria

Can communicate orally

I am under 18 and will have a legal guardian with me for consent.

I have been a dermatology patient for over 5 years and am about to have my first laser procedure.

Exclusion Criteria

Prisoners

I am a minor currently in foster care.

I cannot communicate in English.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo two laser procedures with crossover between VR-PAT intervention and control groups

2 sessions

2 visits (in-person)

Follow-up

Participants are monitored for pain and anxiety immediately following each laser procedure

Immediately following each procedure

Treatment Details

Interventions

• VR-PAT

Trial Overview The study tests Virtual Reality Pain Alleviation Therapy (VR-PAT) to manage pain and anxiety during pediatric outpatient laser procedures. The hypothesis is that VR-PAT will help reduce pain and anxiety compared to those not using it during the treatment.

Participant Groups

Group I: VR-PAT Experimental Treatment 1 Intervention

Participant wears the Pico Neo 3 Pro Eye headset and actively plays the VR-PAT game.

Group II: Control Active Control 1 Intervention

Participant wears the Pico Neo 3 Pro Eye headset to protect eyes, but it is not turned on.

Who Is Running the Clinical Trial?

Nationwide Children's Hospital

Lead Sponsor

Trials

354

Recruited

5,228,000+

Findings from Research

In a study involving 64 children aged 7 to 16 undergoing venous cannulation, the use of a three-dimensional virtual reality (VR) game as a distraction led to higher patient satisfaction compared to standard care, with 100% of children in the VR group preferring it for future procedures.

Although the VR intervention did not significantly reduce pain scores or procedural times compared to standard care, it was well-received and had a low incidence of adverse effects, suggesting it can be a valuable addition to pain management strategies for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immersive Virtual Reality for Pediatric Procedural Pain: A Randomized Clinical Trial. Walther-Larsen, S., Petersen, T., Friis, SM., et al.[2020]

In a study involving 49 pediatric patients undergoing phlebotomy for food allergy diagnosis, those using virtual reality (VR) experienced significantly less anxiety and fear during the procedure compared to those receiving standard care.

The VR group also reported lower pain levels and demonstrated better procedural compliance, suggesting that interactive VR applications can effectively improve the experience of pediatric patients during potentially stressful medical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality Reduces Pediatric Anxiety During Food Allergy Clinical Trials: A Pilot Randomized, Pragmatic Study. Alonzi, S., Caruso, TJ., Sindher, SB., et al.[2022]

In a study involving 106 children aged 4-7 years undergoing venous cannulation, the use of a virtual reality (VR) game as a distraction did not significantly reduce pain compared to standard distraction methods using tablets or smartphones, with both groups reporting similar pain levels.

Patient satisfaction was high in both groups, and the study found no significant differences in procedural times or adverse effects, indicating that VR can be an acceptable distraction method but may not provide additional pain relief benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial on virtual reality distraction during venous cannulation in young children. Thybo, KH., Friis, SM., Aagaard, G., et al.[2022]

This study demonstrates that immersive virtual reality (VR) can significantly increase heat-pain tolerance limits in healthy participants, suggesting its potential as a nonpharmacological intervention for pain management.

VR not only enhances pain tolerance but also improves mood and reduces situational anxiety when the experience is enjoyable, although these mood changes do not directly affect pain tolerance levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality: physiological and behavioral mechanisms to increase individual pain tolerance limits. Colloca, L., Raghuraman, N., Wang, Y., et al.[2022]

A novel virtual reality neuroscience-based therapy (VRNT) significantly reduced pain intensity and interference in 31 participants with chronic back pain compared to usual care, with effects lasting for at least two weeks after treatment.

VRNT not only improved pain-related outcomes but also enhanced overall functioning by potentially altering brain networks associated with pain, as indicated by MRI findings showing changes in connectivity and white matter integrity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Virtual Reality Neuroscience-based Therapy on Clinical and Neuroimaging Outcomes in Patients with Chronic Back Pain: A Randomized Clinical Trial. Čeko, M., Baeuerle, T., Webster, L., et al.[2023]

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]

Virtual reality (VR) gaming technologies show promise in enhancing chronic pain interventions, particularly in treating conditions like chronic low back pain by addressing pain-related fear and disability.

The review suggests that while VR can optimize existing therapies, there are limitations with traditional VR interfaces that need to be addressed for effective chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The promise and challenge of virtual gaming technologies for chronic pain: the case of graded exposure for low back pain. Trost, Z., Zielke, M., Guck, A., et al.[2015]

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]

References

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

Can virtual reality enhance the patient experience during awake invasive procedures? A systematic review of randomized controlled trials. [2023]

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

Immersive Virtual Reality for Pediatric Procedural Pain: A Randomized Clinical Trial. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Immersive Virtual Reality for Pain Control and Anxiolysis During IV Blood Draws in Adults: A Randomized Controlled Trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Effectiveness of virtual reality intervention on reducing the pain, anxiety and fear of needle-related procedures in paediatric patients: A systematic review and meta-analysis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Immersive virtual reality vs. non-immersive distraction for pain management of children during bone pins and sutures removal: A randomized clinical trial protocol. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Virtual Reality Reduces Pediatric Anxiety During Food Allergy Clinical Trials: A Pilot Randomized, Pragmatic Study. [2022]

7. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial on virtual reality distraction during venous cannulation in young children. [2022]

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

Interactive video games to reduce paediatric procedural pain and anxiety: a systematic review and meta-analysis. [2021]

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

Virtual reality: physiological and behavioral mechanisms to increase individual pain tolerance limits. [2022]

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

The Effects of Virtual Reality Neuroscience-based Therapy on Clinical and Neuroimaging Outcomes in Patients with Chronic Back Pain: A Randomized Clinical Trial. [2023]

11. 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]

12. England pubmed.ncbi.nlm.nih.gov

The promise and challenge of virtual gaming technologies for chronic pain: the case of graded exposure for low back pain. [2015]

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

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