Immersive Technology for Procedural Anxiety

Overseen By Man Yee Suen, MMedSc

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Neurological condition, Developmental disability, 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 explores whether virtual reality (VR) or augmented reality (AR) headsets can reduce anxiety and pain in children during minor medical procedures, such as lumbar punctures or cardiac catheterizations. Researchers aim to determine if these immersive technologies, a form of tech-based distraction, outperform traditional methods that do not use such distractions. The goal is to reduce medication use and improve pain and anxiety scores, as well as discharge times. Children aged 4-17 who speak English and are undergoing minor procedures at Stanford Hospital may be eligible. As an unphased trial, this study offers participants a unique chance to contribute to innovative research that could transform pediatric care.

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 discuss this with the trial coordinators or your doctor.

What prior data suggests that these immersive technologies are safe for pediatric patients?

Research has shown that virtual reality (VR) can reduce anxiety during medical procedures. Studies have found that VR therapy positively impacts patients with anxiety disorders by lowering their anxiety levels.

Additionally, VR headsets often prove more effective than tablets in reducing pain and anxiety during short procedures. Importantly, these technologies are generally well-tolerated, with most people not experiencing negative side effects.

Overall, current research suggests that VR is safe and effectively reduces anxiety and pain during medical procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using immersive technology for reducing procedural anxiety because it offers a novel way to distract and calm patients compared to traditional methods like deep breathing or music. This approach leverages virtual reality headsets and haptic devices, like the Buddy Guard, to create engaging, multisensory experiences that can divert attention away from anxiety-inducing procedures. By providing an interactive environment, these technologies have the potential to not only reduce anxiety more effectively but also to enhance the overall patient experience during medical procedures.

What evidence suggests that immersive technology is effective for reducing procedural anxiety in pediatric patients?

Research shows that virtual reality (VR) therapy can help reduce anxiety and pain. Studies have found that VR greatly improves anxiety levels in patients, including those undergoing medical procedures. For children, VR is particularly useful in managing pain and anxiety during uncomfortable procedures. Most studies emphasize that VR is safe and effective for reducing anxiety and pain in both short- and long-term situations. In this trial, participants in the Immersive Technology group will use VR headsets and other immersive technologies during minor procedures, potentially easing anxiety and pain in children. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for pediatric patients experiencing anxiety or procedural anxiety during minor procedures like lumbar punctures and cardiac catheterization. The study aims to include those who typically receive standard care without technology-based distractions.

Inclusion Criteria

English speaking

Parental consent/patient assent

I am between 4 and 17 years old.

Exclusion Criteria

Patient with a significant neurological condition or major developmental disability

History of severe motion sickness

I have had issues with my vision.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants undergo minor procedures with or without technology-based distractions

1 day

1 visit (in-person)

Immediate Post-Intervention Assessment

Participants' pain and anxiety levels are assessed immediately after the intervention

Immediately after intervention

Follow-up

Participants are monitored for satisfaction and overall effectiveness of the intervention

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Immersive technology

Trial Overview

The study is testing if using immersive technologies such as Virtual Reality (VR) or Augmented Reality (AR) headsets can better reduce pain and anxiety compared to the usual approach of no tech distractions during minor medical procedures.

How Is the Trial Designed?

Group I: Immersive Technology grorup Experimental Treatment 1 Intervention

Immersive technologies including VR headsets, a bluetooth haptic device (Buddy Guard), a screen and projector (BERT), and a tablets with a game will be randomly assigned to the participants. Each participant will receive one technological intervention.

Group II: Standard of Care group Active Control 1 Intervention

No immersive technology will be assigned to the participant. Participant will use their own distraction method.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

Virtual Reality exposure therapy (VRET) has been proven effective in reducing fear and anxiety through decades of research and over 20 randomized controlled trials, but access has been limited due to the high cost of equipment.

Recent advancements in consumer VR technology, like Oculus Rift and Samsung Gear, now allow for broader implementation of VRET in clinical settings and self-help applications, making it more accessible for both providers and patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creating state of the art, next-generation Virtual Reality exposure therapies for anxiety disorders using consumer hardware platforms: design considerations and future directions. Lindner, P., Miloff, A., Hamilton, W., et al.[2018]

Over the past 20 years, there has been a notable decrease in adverse events related to sedation outside of operating rooms, highlighting improvements in patient safety during procedures.

Immersive virtual reality (VR) is emerging as an effective non-pharmacologic technique to distract patients from anxiety and pain during various medical procedures, with its application expected to grow as technology advances and costs decrease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Emerging Role of Virtual Reality as an Adjunct to Procedural Sedation and Anesthesia: A Narrative Review. Hitching, R., Hoffman, HG., Garcia-Palacios, A., et al.[2023]

Immersive technology, particularly virtual reality, has been increasingly studied as a safe and effective non-drug option for managing perioperative anxiety and pain in children, with several studies showing positive results over the last three years.

Despite the promising findings, most studies have small sample sizes and varied methods, highlighting the need for more rigorous research, such as larger randomized controlled trials, to better understand the effectiveness and potential side effects of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

State of the Art: Immersive Technologies for Perioperative Anxiety, Acute, and Chronic Pain Management in Pediatric Patients. Alqudimat, M., Mesaroli, G., Lalloo, C., et al.[2022]

A study involving 30 children aged 6-18 years undergoing radiation therapy showed that an immersive Virtual Reality (VR) intervention significantly reduced anxiety levels in both children and their parents, enhancing their understanding of the procedures.

The VR intervention was highly accepted by participants, with only one child (3.33%) requiring general anesthesia after the intervention, suggesting that VR could improve compliance and reduce the need for more invasive sedation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of immersive virtual reality exposure in preparing pediatric oncology patients for radiation therapy. Tennant, M., Anderson, N., Youssef, GJ., et al.[2023]

In a clinical trial involving 107 young patients (ages 10-21) undergoing peripheral intravenous catheter placement, those who used a virtual reality (VR) intervention reported significantly lower levels of pain and anxiety compared to those receiving standard care.

The VR group showed a reduction in anxiety scores by 1.85 points and pain scores by 1.34 points, indicating that VR can be an effective tool for improving the experience of painful medical procedures in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of an Immersive Virtual Reality Intervention on Pain and Anxiety Associated With Peripheral Intravenous Catheter Placement in the Pediatric Setting: A Randomized Clinical Trial. Gold, JI., SooHoo, M., Laikin, AM., et al.[2022]

Citations

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Immersive Technology for Procedural Anxiety

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The aim of this scoping review was to analyze and sum up the most recent developments in Virtual Reality (VR) use for therapeutic care and medical education.

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researchprotocols.org

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This study aims to explore the effectiveness of a cooperative virtual reality (VR) game as a novel nonpharmacological solution to reduce anxiety and pain

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tandfonline.com/doi/full/10.1080/10494820.2025.2542898

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The learning outcomes indicate notable improvements in behavioral skills and learner engagement but only modest gains in declarative knowledge. Full-IVR ...