700 Participants Needed

VR Therapy for Pain and Anxiety During Medical Procedures

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

Trial Summary

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 data supports the effectiveness of the treatment Merge VR for pain and anxiety during medical procedures?

Research shows that virtual reality (VR) can help reduce pain and anxiety during medical procedures. For example, a study found that using VR during orthopedic procedures reduced pain intensity by 43% and anxiety by 43%. Another study with burn patients showed that VR made pain less intense and more bearable during therapy.12345

Is virtual reality therapy safe for reducing pain and anxiety during medical procedures?

Research suggests that virtual reality (VR) therapy is generally safe for reducing pain and anxiety during medical procedures. Studies have shown that VR can effectively reduce pain and anxiety without the risks associated with anesthesia or high doses of pain medication, making it a promising non-drug option for pain management.36789

How does VR therapy differ from other treatments for pain and anxiety during medical procedures?

VR therapy is unique because it uses immersive virtual environments to distract patients from pain and anxiety, unlike traditional treatments that often rely on medications. This non-drug approach can be more cost-effective and accessible, providing relief without the side effects associated with painkillers.45101112

What is the purpose of this trial?

This trial tests if VR can reduce pain and anxiety in children aged 7-21 during medical procedures by distracting them with a virtual world. The study compares the effectiveness of using VR versus not using VR. Virtual reality (VR) has been shown to decrease pain and anxiety in children undergoing various medical procedures.

Research Team

JI

Jeffrey I Gold, PhD

Principal Investigator

Children's Hospital Los Angeles

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: VR RandomizationExperimental Treatment3 Interventions
Children in the VR condition will undergo the invasive procedure while distracted by interaction with an immersive virtual environment (VE) presented via a head mounted display (HMD). The intervention group will receive standard CHLA treatment with VR distraction.
Group II: Standard of Care (No VR) RandomizationActive Control1 Intervention
In the standard of care treatment condition, participants will receive the standard CHLA treatment protocol for the medical procedure.

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+

Findings from Research

Virtual reality (VR) therapy has shown potential to improve clinical outcomes, such as reduced pain and anxiety, in adult patients undergoing surgical procedures, based on a review of 18 studies.
Factors like patient comfort and healthcare worker concerns about cost-effectiveness and infection control influence the acceptability and feasibility of VR therapy in acute care settings, indicating a need for further research to solidify its effectiveness.
Virtual reality interventions and the outcome measures of adult patients in acute care settings undergoing surgical procedures: An integrative review.Wang, S., Lim, SH., Aloweni, FBAB.[2022]
A study involving 100 hospitalized patients showed that a one-time 3D virtual reality (VR) intervention significantly reduced pain more than a 2D distraction video, with an average pain reduction of -1.3 points compared to -0.6 points for the control group.
The VR intervention was not only effective, with 65% of patients experiencing a meaningful pain response, but it was also safe, as no adverse events were reported during the study.
Virtual Reality for Management of Pain in Hospitalized Patients: Results of a Controlled Trial.Tashjian, VC., Mosadeghi, S., Howard, AR., et al.[2020]
A case study demonstrated that immersive virtual reality (VR) significantly reduced pain intensity by 43% and anxiety by 43% during the removal of external fixator pins in a conscious patient, compared to standard care without VR.
Using VR as a non-pharmacologic analgesic not only improved patient satisfaction with pain management but also has the potential to lower opioid use and associated risks during outpatient orthopedic procedures.
Case Report: Virtual Reality Analgesia in an Opioid Sparing Orthopedic Outpatient Clinic Setting: A Case Study.Firoozabadi, R., Elhaddad, M., Drever, S., et al.[2021]

References

Virtual reality interventions and the outcome measures of adult patients in acute care settings undergoing surgical procedures: An integrative review. [2022]
Virtual Reality for Management of Pain in Hospitalized Patients: Results of a Controlled Trial. [2020]
Case Report: Virtual Reality Analgesia in an Opioid Sparing Orthopedic Outpatient Clinic Setting: A Case Study. [2021]
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]
Feasibility of articulated arm mounted Oculus Rift Virtual Reality goggles for adjunctive pain control during occupational therapy in pediatric burn patients. [2022]
Systematic Review and Meta-analysis of Virtual Reality in Pediatrics: Effects on Pain and Anxiety. [2020]
A Virtual Reality Intervention for the Treatment of Phantom Limb Pain: Development and Feasibility Results. [2020]
Virtual reality helmet display quality influences the magnitude of virtual reality analgesia. [2022]
Guided relaxation-based virtual reality versus distraction-based virtual reality or passive control for postoperative pain management in children and adolescents undergoing Nuss repair of pectus excavatum: protocol for a prospective, randomised, controlled trial (FOREVR Peds trial). [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Effect of Virtual Reality Therapy in Reducing Pain and Anxiety for Cancer-Related Medical Procedures: A Systematic Narrative Review. [2021]
Use of Virtual Reality for the Management of Anxiety and Pain in Dental Treatments: Systematic Review and Meta-Analysis. [2020]
12.United Statespubmed.ncbi.nlm.nih.gov
Virtual Reality as a Clinical Tool for Pain Management. [2018]
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