VR Therapy for Pain and Anxiety During Medical Procedures

Overseen by Jeffrey I Gold, PhD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Children's Hospital Los Angeles

Must not be taking: Pain medications, Anxiolytics

Disqualifiers: Psychiatric disorder, Cognitive disorders, Seizure, others

No Placebo Group

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{3 6 7 8 9}

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. ^{4 5 10 11 12}

Research Team

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:

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.

Trial 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 (Behavioural Intervention)
• Oculus Go (Behavioural Intervention)
• Samsung Gear VR (Behavioural Intervention)

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

Group I: VR Randomization Experimental Treatment 3 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) Randomization Active Control 1 Intervention

In the standard of care treatment condition, participants will receive the standard CHLA treatment protocol for the medical procedure.

Who Is Running the Clinical Trial?

Children's Hospital Los Angeles

Lead Sponsor

Trials

257

Recruited

5,075,000+

Paul S. Viviano

Children's Hospital Los Angeles

Chief Executive Officer since 2015

Master of Public Health from UCLA Fielding School of Public Health

Alan S. Wayne

Children's Hospital Los Angeles

Chief Medical Officer since 2023

MD

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality for Management of Pain in Hospitalized Patients: Results of a Controlled Trial. Tashjian, VC., Mosadeghi, S., Howard, AR., et al.[2020]

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]

An 11-year-old burn patient experienced significant pain reduction during therapy when using inexpensive Oculus Rift Virtual Reality (VR) goggles, with pain intensity ratings dropping from severely painful to moderately painful.

This study suggests that immersive VR environments can be an effective and cost-efficient method for managing acute procedural pain in burn patients, warranting further research into its broader applications in pain control and therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of articulated arm mounted Oculus Rift Virtual Reality goggles for adjunctive pain control during occupational therapy in pediatric burn patients. Hoffman, HG., Meyer, WJ., Ramirez, M., et al.[2022]

A meta-analysis of 17 studies involving pediatric patients showed that virtual reality (VR) significantly reduces pain (SMD = 1.30) and anxiety (SMD = 1.32) during medical procedures, indicating its effectiveness as a distraction tool.

The research primarily focused on VR as a distraction during procedures like burn care, but more studies are needed to explore its potential as a preparatory tool for medical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review and Meta-analysis of Virtual Reality in Pediatrics: Effects on Pain and Anxiety. Eijlers, R., Utens, EMWJ., Staals, LM., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality helmet display quality influences the magnitude of virtual reality analgesia. Hoffman, HG., Seibel, EJ., Richards, TL., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Virtual reality (VR) therapies have shown promise in effectively distracting patients from both acute and chronic pain, suggesting a new approach to pain management beyond traditional methods like opioids and physical therapy.

Clinical studies indicate that VR can be beneficial for various pain conditions, including fibromyalgia and phantom limb pain, by immersing patients in interactive environments that reduce their perception of pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality as a Clinical Tool for Pain Management. Pourmand, A., Davis, S., Marchak, A., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Virtual reality interventions and the outcome measures of adult patients in acute care settings undergoing surgical procedures: An integrative review. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

Virtual Reality for Management of Pain in Hospitalized Patients: Results of a Controlled Trial. [2020]

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

Case Report: Virtual Reality Analgesia in an Opioid Sparing Orthopedic Outpatient Clinic Setting: A Case Study. [2021]

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

Feasibility of articulated arm mounted Oculus Rift Virtual Reality goggles for adjunctive pain control during occupational therapy in pediatric burn patients. [2022]

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

Systematic Review and Meta-analysis of Virtual Reality in Pediatrics: Effects on Pain and Anxiety. [2020]

7. England pubmed.ncbi.nlm.nih.gov

A Virtual Reality Intervention for the Treatment of Phantom Limb Pain: Development and Feasibility Results. [2020]

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

Virtual reality helmet display quality influences the magnitude of virtual reality analgesia. [2022]

9. England pubmed.ncbi.nlm.nih.gov

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 States pubmed.ncbi.nlm.nih.gov

Effect of Virtual Reality Therapy in Reducing Pain and Anxiety for Cancer-Related Medical Procedures: A Systematic Narrative Review. [2021]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Use of Virtual Reality for the Management of Anxiety and Pain in Dental Treatments: Systematic Review and Meta-Analysis. [2020]

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

Virtual Reality as a Clinical Tool for Pain Management. [2018]