700 Participants Needed

VR Therapy for Pain and Anxiety During Medical Procedures

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Overseen ByNhat Ngo, BS, BA
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how virtual reality (VR) might reduce pain and anxiety in children during medical procedures, such as receiving an IV or having a cast removed. Researchers compare the standard care at Children's Hospital Los Angeles with an added VR experience using devices like Merge VR and Oculus Go. Children aged 7 to 21, who speak English and undergo a painful procedure, may qualify if they are not currently on pain or anxiety medication and do not have certain medical conditions. The goal is to determine if VR can make these experiences less stressful and painful for children. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could transform pediatric care.

Do I need to stop my current medications to join the trial?

Yes, if you are currently taking pain or anxiety medications, you cannot participate in this trial.

What prior data suggests that virtual reality is safe for reducing pain and anxiety in children during medical procedures?

Research has shown that virtual reality (VR) is generally safe and effective for managing pain during medical procedures. Studies have found that VR can help control pain in various situations, such as surgeries and long-term pain conditions.

Most people tolerate VR therapy well. However, if discomfort occurs, it is important to stop using it. Some individuals might experience dizziness or headaches, so taking breaks is advisable if needed.

Overall, VR is considered a safe method to reduce pain and anxiety, especially for children undergoing medical procedures.12345

Why are researchers excited about this trial?

Researchers are excited about VR therapy for managing pain and anxiety during medical procedures because it offers a totally different approach compared to traditional methods like medication or sedation. Unlike these standard treatments, VR therapy uses immersive virtual environments to distract and engage patients, which can reduce the perception of pain and anxiety without the side effects associated with drugs. This cutting-edge technique not only provides a novel delivery method through head-mounted displays but also has the potential to enhance the overall patient experience, making medical procedures less daunting for children.

What evidence suggests that VR is effective for reducing pain and anxiety in children during medical procedures?

Research has shown that virtual reality (VR) therapy can help reduce pain and anxiety during medical procedures. In this trial, some participants will receive VR therapy, engaging with virtual worlds to distract them during their procedures. Studies have found that VR technology effectively controls pain through such distractions. For children undergoing painful procedures, VR can significantly lower pain and anxiety. Reviews highlight VR's success in managing sudden pain, making it a promising tool for pain relief without medication. Using VR in medical settings offers a fun and engaging way to ease discomfort during difficult procedures.13678

Who Is on the Research Team?

JI

Jeffrey I Gold, PhD

Principal Investigator

Children's Hospital Los Angeles

Are You a Good Fit for This Trial?

This trial is for children aged 7-21 who speak English, undergoing painful medical procedures like IV placements or cast removals. They must be developing normally as reported by parents and not taking pain or anxiety medication, have no seizure history, flu-like symptoms, cognitive disorders, sensory deficits, or motion sickness.

Inclusion Criteria

Only children who are in the normal range of development will be recruited for this study. This will be assessed by report from the parents. The rationale for excluding patients with developmental delay is that due to their cognitive impairments, such children react to the stressors of surgery differently than do children without such developmental delay. It is unclear how such children would use the interventions included in this study, and it is likely that their responses on baseline and outcome measures will differ from children of normal developmental parameters.
This criterion does not provide specific information.
Inclusion criteria for healthcare providers:
See 5 more

Exclusion Criteria

My child has a history of seizures.
My child gets motion sickness.
My child is currently experiencing flu-like symptoms, a headache, or an earache.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo painful medical procedures with or without VR distraction

Single session
1 visit (in-person)

Follow-up

Participants are monitored for pain and anxiety levels post-procedure

Approximately 5-15 minutes after procedure

Data Analysis

Data collected from surveys and scales are analyzed to assess the effectiveness of VR

What Are the Treatments Tested in This Trial?

Interventions

  • Merge VR
  • Oculus Go
  • Samsung Gear VR
Trial Overview The study tests if VR headsets (Samsung Gear VR, Merge VR, Oculus Go) can reduce pain and anxiety in kids during medical procedures at CHLA. It measures their comfort levels through what they and their caregivers say.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: VR RandomizationExperimental Treatment3 Interventions
Group II: Standard of Care (No VR) RandomizationActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Hospital Los Angeles

Lead Sponsor

Trials
257
Recruited
5,075,000+

AppliedVR Inc.

Industry Sponsor

Trials
11
Recruited
3,100+

Published Research Related to This Trial

A systematic review of nine studies on the use of immersive virtual reality (VR) for pain and anxiety management in cancer patients showed a trend towards improvement, but only two studies demonstrated statistically significant results.
The current evidence is inconclusive due to methodological limitations and small sample sizes, highlighting the need for further research to better understand the effectiveness of VR in this context.
Effect of Virtual Reality Therapy in Reducing Pain and Anxiety for Cancer-Related Medical Procedures: A Systematic Narrative Review.Chow, H., Hon, J., Chua, W., et al.[2021]
Virtual reality (VR) has been shown to effectively reduce pain and anxiety in patients undergoing dental treatments, particularly in children, with a significant effect size of -0.82 for pain reduction based on a meta-analysis of 10 studies.
Despite its effectiveness in pediatric patients, there is a need for more research on the use of VR for adults and its potential as a preparatory tool for dental treatments, as current studies are limited.
Use of Virtual Reality for the Management of Anxiety and Pain in Dental Treatments: Systematic Review and Meta-Analysis.López-Valverde, N., Muriel Fernández, J., López-Valverde, A., et al.[2020]
A study involving 77 healthy volunteers demonstrated that a High-Tech VR helmet significantly reduced procedural pain more effectively than a Low-Tech VR helmet, with participants reporting up to 34% less worst pain and 46% less pain unpleasantness.
The High-Tech VR helmet also led to a higher percentage of participants experiencing clinically significant pain reduction (65% vs. 29% in the Low-Tech group), emphasizing the importance of VR technology quality in pain management during medical procedures.
Virtual reality helmet display quality influences the magnitude of virtual reality analgesia.Hoffman, HG., Seibel, EJ., Richards, TL., et al.[2022]

Citations

Efficacy of virtual reality for pain relief in medical proceduresImmersive VR technology offers effective pain control across various medical procedures, albeit statistical heterogeneity.
Virtual reality for pain management: an umbrella reviewThis umbrella review demonstrates successful application of virtual reality in pain control, including perioperative, periprocedural, and chronic pain settings.
VR Therapy for Pain and Anxiety During Medical ProceduresThis trial tests if VR can reduce pain and anxiety in children aged 7-21 during medical procedures by distracting them with a virtual world.
(PDF) Efficacy of virtual reality for pain relief in medical ...We aimed to evaluate the efficacy of Immersive virtual reality (VR) technology in reducing patient's pain perception during various medical ...
Using Virtual Reality Exposure Therapy in Pain ManagementVR can effectively alleviate acute pain. In terms of chronic low back pain and cancer-related pain, there was no statistical difference between ...
Health & Safety Information | AR/VR Learning & CreationNEVER continue to use the Merge Headset if you are experiencing any discomfort. WARNING-IN THE EVENT YOU EXPERIENCE DISCOMFORT. IMMEDIATELY DISCONTINUE USE ...
Virtual Reality in Chronic Pain Rehabilitation: A Systematic ...VR interventions are safe and effective for chronic pain management in rehabilitation settings. Immersive and non-immersive techniques are used in VR ...
Fully Immersive Virtual Reality Using 360° Videos to ...The aim of this scoping review is to assess the effectiveness of 360° interventions on well-being in older adults with or without cognitive impairment.
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