Virtual Reality for Acute Pain in Children

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

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Nationwide Children's Hospital

Must not be taking: Pain medications

Disqualifiers: Pain, Impairments, Seizure, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how virtual reality (VR) can reduce pain during medical procedures for children. Researchers will use a special brain imaging tool to study pain responses and relief as children engage in activities like playing a VR game or watching a VR video. The goal is to predict and enhance how VR manages pain. Children who are healthy, not currently experiencing pain, and understand English may be suitable for this trial. As an unphased trial, this study provides a unique opportunity for children to contribute to innovative research that could improve pain management techniques for future patients.

Will I have to stop taking my current medications?

The trial requires that participants have not taken any pain medication within the past 12 hours before participating.

What prior data suggests that Virtual Reality Pain Alleviation Therapy (VR-PAT) is safe for children?

Research shows that Virtual Reality for Pain Relief (VR-PAT) is generally safe for helping children manage sudden pain. Studies have found that VR effectively reduces pain during various medical procedures for kids and lowers their anxiety about these procedures. Most research indicates that VR is well-tolerated, with few reports of negative side effects.

Although VR is not yet widely used for pain management, existing studies highlight its safety and effectiveness. Many parents also feel positive about using VR to relieve their children's pain. Overall, VR-PAT appears to be a promising and safe method for managing pain in children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Virtual Reality Pain Alleviation Therapy (VR-PAT) for acute pain in children because it offers a novel, non-invasive way to manage pain. Unlike traditional pain relief methods, which often rely on medications like acetaminophen or ibuprofen, VR-PAT uses immersive virtual reality experiences to distract and engage children, reducing their perception of pain. The active engagement in a VR game may enhance the pain relief effect compared to passive viewing or non-immersive platforms like an iPad. This innovative approach not only aims to minimize the need for medication but also makes pain management interactive and potentially more effective for kids.

What evidence suggests that Virtual Reality Pain Alleviation Therapy could be effective for acute pain in children?

This trial will compare different approaches to pain management in children using Virtual Reality Pain Alleviation Therapy (VR-PAT). Studies have shown that VR-PAT effectively reduces pain and anxiety in children. Research indicates that VR provides a safe, non-drug method for pain relief during medical procedures. Specifically, VR has been found to lower pain levels and help children focus less on their pain. Evidence suggests VR may outperform traditional methods like distraction and relaxation techniques. Overall, VR-PAT has shown promising results in reducing pain and stress for children in medical settings. Participants in this trial may experience different forms of VR-PAT, including active and passive VR experiences, or compare these to traditional methods like playing a game on an iPad. ^{1 2 6 7 8}

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 healthy children who can participate in a study involving simulated pain and virtual reality. They will be part of an experiment to understand how the brain reacts to pain and if VR can help manage it.

Inclusion Criteria

I am between 6 and 17 years old.

Subjects and legal guardians can communicate (read and write) using English

Exclusion Criteria

I have a history of motion sickness, seizures, dizziness, or migraines triggered by visual auras.

I have taken pain medication in the last 12 hours.

Minors in foster care, incarcerated, or currently pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Experimental Session

Participants undergo a 1-hour research visit involving simulated pain and VR interventions

1 hour

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the experimental session

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality Pain Alleviation Therapy (VR-PAT)

Trial Overview

The study tests how different forms of distraction (an immersive VR game, a passive VR video, and playing on an iPad) affect the brain's response to simulated pain using fNIRS neuroimaging technology.

How Is the Trial Designed?

Group I: Active VR-PAT Experimental Treatment 1 Intervention

Participants will wear an fNIRS neuroimaging device and undergo an experimental pain session using a blood pressure cuff around the calf. Participants actively play an engaging virtual reality game on a VR headset.

Group II: Control Active Control 1 Intervention

Participants will wear an fNIRS neuroimaging device and undergo an experimental pain session using a blood pressure cuff around the calf. No distraction tool will be used.

Group III: Passive VR-PAT Active Control 1 Intervention

Participants will wear an fNIRS neuroimaging device and undergo an experimental pain session using a blood pressure cuff around the calf. Participants view a video of the same VR game on a VR headset, without engagement.

Group IV: iPad game Active Control 1 Intervention

Participants will wear an fNIRS neuroimaging device and undergo an experimental pain session using a blood pressure cuff around the calf. Participants actively play the same VR game on an iPad, without the immersion of a VR headset.

Who Is Running the Clinical Trial?

Nationwide Children's Hospital

Lead Sponsor

Trials

354

Recruited

5,228,000+

Published Research Related to This Trial

The INOVATE-Pain consortium, consisting of 16 experts, aims to improve the use of virtual reality (VR) and augmented reality (AR) in treating pediatric chronic pain by establishing best practices for designing and evaluating these interventions.

Key recommendations include fostering partnerships among stakeholders, standardizing outcome measures for evaluation, and ensuring access to resources, all of which are essential for developing effective VR-based pain management solutions for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leveraging Virtual Reality and Augmented Reality to Combat Chronic Pain in Youth: Position Paper From the Interdisciplinary Network on Virtual and Augmented Technologies for Pain Management. Logan, DE., Simons, LE., Caruso, TJ., et al.[2021]

A case study involving a 16-year-old patient with cerebral palsy showed that using virtual reality (VR) during physiotherapy sessions significantly reduced pain levels by 41.2% compared to sessions without VR.

This study suggests that VR can be an effective non-pharmacologic pain management strategy for children recovering from surgery, especially for those who may not tolerate traditional pain medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality as a pediatric pain modulation technique: a case study. Steele, E., Grimmer, K., Thomas, B., et al.[2011]

In a case series involving 10 chronic pain patients, 5 reported reduced pain during virtual reality (VR) therapy sessions, suggesting potential short-term benefits of VR for pain management.

While VR therapy did not show significant overall changes in pain scores after treatment, it was safe with no serious adverse events, although 60% of participants experienced some cybersickness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality as an Adjunct Home Therapy in Chronic Pain Management: An Exploratory Study. Garrett, B., Taverner, T., McDade, P.[2020]

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]

Citations

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It was developed for pain alleviation during burn dressing changes by Nationwide Children's Research Information Solutions and Innovation ...