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

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality headset, Augmented Reality Headset) are more effective than the standard of care (i.e., no technology-based distraction) for decreasing anxiety and pain scores in pediatric patients undergoing various minor procedures (i.e lumbar punctures and cardiac catheterization). The anticipated primary outcome will be a reduction of overall cumulative medication and secondary outcomes include but are not limited to: physician satisfaction, discharge time, pain scores, anxiety scores, and procedure time.

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.

Is immersive technology safe for reducing anxiety during medical procedures?

Research shows that immersive technology like virtual reality is generally safe for reducing anxiety during medical procedures, with no significant adverse events reported in studies. ^{1 2 3 4 5}

How does immersive technology treatment differ from other treatments for procedural anxiety?

Immersive technology, such as Virtual Reality (VR), offers a unique approach to treating procedural anxiety by creating a virtual environment that can simulate real-life scenarios, allowing patients to experience and manage their anxiety in a controlled setting. Unlike traditional methods, this treatment leverages consumer VR systems, making it more accessible and cost-effective, and it can be tailored to individual needs through features like gamification and virtual social learning. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Immersive technology for procedural anxiety?

Research shows that immersive virtual reality (a type of immersive technology) can help reduce anxiety during medical procedures, such as surgery and radiation therapy, by creating a virtual environment that distracts and calms patients. ^{1 3 5 11 12}

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

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]

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]

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]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of Immersive Virtual Reality on Patient Anxiety During Surgery Under Regional Anesthesia: A Randomized Clinical Trial. [2023]

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

State of the Art: Immersive Technologies for Perioperative Anxiety, Acute, and Chronic Pain Management in Pediatric Patients. [2022]

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

Effects of immersive virtual reality exposure in preparing pediatric oncology patients for radiation therapy. [2023]

4. United States 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. [2022]

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

Virtual reality and noise canceling headphone distraction during pediatric dermatologic procedures. [2023]

6. 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]

7. Switzerland pubmed.ncbi.nlm.nih.gov

The Emerging Role of Virtual Reality as an Adjunct to Procedural Sedation and Anesthesia: A Narrative Review. [2023]

8. England 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. [2018]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Virtual reality combats test anxiety: a case study report. [2004]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Do conversations with virtual avatars increase feelings of social anxiety? [2019]

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

A meta-analysis on the relationship between self-reported presence and anxiety in virtual reality exposure therapy for anxiety disorders. [2022]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Arguing in Favor of Revising the Simulator Sickness Questionnaire Factor Structure When Assessing Side Effects Induced by Immersions in Virtual Reality. [2021]