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

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The objective of this study is to develop central nervous system (CNS) biomarkers of pain experienced during medical procedures and pain relief induced by Virtual Reality Pain Alleviation Therapy (VR-PAT). The study team plans to use innovative functional near-infrared spectroscopy (fNIRS) to identify and quantify the targeted CNS biomarkers. The ultimate goal of this project is to optimize the CNS biomarkers for predicting and/or monitoring response to virtual reality (VR)-based pain reduction approaches for pain management in clinical trials. 20 healthy children will be recruited for a 1-hour research visit where they will wear a blood pressure cuff to simulate pain and an fNIRS neuroimaging device while playing an immersive/engaging VR game, a passive VR video, and an iPad game.

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.

Is virtual reality safe for children in clinical trials for pain management?

Virtual reality (VR) has been used in various studies to help manage pain in children, and while it shows promise as a non-drug option, more research is needed to fully understand its safety and effectiveness. Current studies suggest VR is generally safe, but larger trials are necessary to confirm this. ^{1 2 3 4 5}

How is Virtual Reality Pain Alleviation Therapy (VR-PAT) different from other treatments for acute pain in children?

VR-PAT is unique because it uses virtual reality (VR) as a non-drug method to help distract children from pain, making it different from traditional pain treatments that often rely on medications. This approach is particularly beneficial for children who may not tolerate or respond well to standard pain medications. ^{1 2 4 5 6}

What data supports the effectiveness of the treatment Virtual Reality Pain Alleviation Therapy (VR-PAT) for acute pain in children?

Research shows that virtual reality (VR) can help reduce pain in children during medical procedures, making it a promising non-drug option for pain relief. Although more studies are needed, VR has been found to be effective in reducing pain and fear in children, suggesting it could be a useful tool for managing acute pain. ^{1 2 3 4 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 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]

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]

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]

Citations

1. Canada 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. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Does virtual reality reduce pain in pediatric patients? A systematic review. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Use of Virtual Reality Distraction to Reduce Child Pain and Fear during Painful Medical Procedures in Children with Physical Disabilities in Uganda: A Feasibility Study. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Virtual Reality Animal Rescue World: Pediatric virtual reality analgesia during just noticeable pressure pain in children aged 2-10 years old (crossover design). [2022]

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

Virtual reality as a pediatric pain modulation technique: a case study. [2011]

7. Canada pubmed.ncbi.nlm.nih.gov

Virtual Reality as an Adjunct Home Therapy in Chronic Pain Management: An Exploratory Study. [2020]