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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new virtual reality game (VR-PAT) designed to help manage pain and anxiety during dermatology laser treatments for children and young adults. Participants will either play the game or wear the headset without playing. The researchers believe that using the game will reduce pain and stress during procedures. The trial seeks dermatology patients undergoing their first laser treatment who can communicate orally. As an unphased trial, it offers participants a unique opportunity to contribute to innovative research that could enhance comfort during medical procedures.

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 prior data suggests that this virtual reality therapy is safe for pain and anxiety management?

Research shows that virtual reality (VR) is generally safe and effective for managing pain and anxiety. Studies have found that using VR as a distraction can effectively reduce pain and anxiety during medical procedures. For example, one review found that VR helped lessen pain and fear during needle procedures in children. This suggests that VR can be a useful tool without causing significant side effects.

In this trial, participants will play a VR game called VR-PAT during laser procedures. Since the trial does not involve testing a new drug, there are no concerns about drug side effects. Instead, the focus is on using technology to help manage pain and anxiety. So far, using VR in similar situations has not led to any major safety issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Virtual Reality Game for Procedural Pain and Anxiety because it offers a novel approach to managing pain and anxiety by using immersive technology. Unlike traditional medications that may involve opioids or sedatives with potential side effects, this method provides a non-invasive, drug-free alternative. The VR-PAT game actively engages participants through the Pico Neo 3 Pro Eye headset, potentially diverting attention away from pain and reducing anxiety during procedures. This innovative use of virtual reality could transform how we manage procedural discomfort, providing a safer and more engaging option for patients.

What evidence suggests that VR-PAT is effective for reducing pain and anxiety during laser procedures?

Research has shown that virtual reality (VR) can reduce pain and anxiety during medical procedures. A review of several studies found that VR significantly lowers pain and anxiety levels in children during these procedures. Another study discovered that using VR as a distraction lessens the feeling of pain and fear during medical treatments. In this trial, participants in the VR-PAT arm will actively play the virtual reality game, which is expected to help kids and young adults feel less pain and anxiety during laser procedures. The evidence supports the idea that VR can serve as a useful distraction, making painful procedures easier to handle. ^{2 3 4 6 7}

Who Is on the Research Team?

Henry Xiang, MD, MPH, PhD, MBA

Principal Investigator

Nationwide Children's Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11117134/

Effectiveness of Virtual Reality in Reducing Perceived Pain ... The purpose of this pilot project is to assess the efficacy of using VR as a distraction-based intervention for anxiety or pain management.

2. frontiersin.org frontiersin.org/journals/virtual-reality/articles/10.3389/frvir.2021.699383/full

The Effects of Virtual Reality on Procedural Pain and ... The present study is a systematic review and meta-analysis of studies that have used VR to reduce procedural pain and anxiety in children.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02794103

Virtual Reality Distraction for Procedural Pain Management ... The aim of this study is to assess the feasibility and preliminary efficacy of a virtual reality prototype developed specifically for the hydrotherapy room of ...

4. withpower.com withpower.com/trial/virtual-reality-game-for-procedural-pain-and-anxiety-0c126

Virtual Reality Game for Procedural Pain and Anxiety 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.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11417701/

Effectiveness of Virtual Reality for Managing Pain, Fear, and ... The use of virtual reality as a distraction appears to be a valuable strategy for reducing pain, fear, and anxiety during needle-related procedures.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05645224

Study Details | NCT05645224 | VR-PAT for Pain and ... 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.

7. researchprotocols.org researchprotocols.org/2025/1/e63098

Cooperative Virtual Reality Gaming for Anxiety and Pain ... This study aims to explore the effectiveness of a cooperative virtual reality (VR) game as a novel nonpharmacological solution to reduce anxiety and pain