Virtual Reality Goggles for Procedural Pain in Children

Overseen By Courtney A McNamara, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Montefiore Medical Center

Disqualifiers: Photosensitive seizures, Infectious concerns, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 day

200 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a randomized non-blinded trial evaluating the effect of virtual reality goggles on perceived pain and anxiety scores during venipuncture on hospitalized children ages 5-21. We will randomized patients to either standard of care (including Lidocaine 2.5%/Prilocaine 2.5% cream as a topical anesthetic 60-240 minutes prior to venipuncture) or standard of care plus virtual reality goggles.

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 focuses on using virtual reality goggles and a topical anesthetic cream for pain management during venipuncture.

What data supports the effectiveness of the treatment Virtual Reality Goggles for Procedural Pain in Children?

Research shows that using virtual reality (VR) can help reduce pain and anxiety in children during medical procedures like needle insertions. In one study, children reported 41.2% less pain when using VR compared to not using it, suggesting VR can be a powerful tool to help manage pain without medication. ^{1 2 3 4 5}

How does the virtual reality treatment for procedural pain in children differ from other treatments?

Virtual reality (VR) goggles offer a unique, non-drug approach to managing procedural pain in children by immersing them in a computer-generated world, which helps distract them from the pain. Unlike traditional pain medications, VR provides a fun and engaging experience that can reduce both the intensity and unpleasantness of pain without the side effects associated with drugs. ^{1 2 4 6 7}

Research Team

Courtney A McNamara, MD

Principal Investigator

Montefiore Medical Center

Eligibility Criteria

This trial is for hospitalized children and young adults aged 5-21 who are scheduled for a venipuncture. It's not suitable for those who don't speak English, Spanish or Arabic, refuse topical anesthetic cream, can't use VR due to physical or developmental reasons, have discomfort with goggles (like recent neurosurgery), photosensitive seizures, or infections like scabies, lice, COVID-19.

Inclusion Criteria

I am between 5 and 21 years old and scheduled for a blood draw on the 6th floor.

Exclusion Criteria

I am willing to use Lidocaine/Prilocaine cream.

I (or my guardian) can communicate in English, Spanish, or Arabic.

You are not able to use the virtual reality equipment because of health reasons, such as recent head surgery, sensitivity to light, or infectious conditions like scabies or COVID-19 that can't be easily cleaned.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 hour

1 visit (in-person)

Treatment

Participants undergo venipuncture with or without virtual reality goggles and receive Lidocaine/Prilocaine cream

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in pain, anxiety, heart rate, and simulator sickness immediately after venipuncture

Immediate post-procedure

1 visit (in-person)

Treatment Details

Interventions

• Virtual Reality Goggles

Trial Overview The study tests if virtual reality goggles can reduce pain and anxiety during venipuncture in patients aged 5-21 compared to the standard care which includes a topical anesthetic. Participants will be randomly assigned to either receive standard care alone or with the addition of VR goggles.

Participant Groups

Group I: VR goggle with venipuncture Experimental Treatment 1 Intervention

Virtual reality goggles SamsungGearVR supplied by KindVR will be placed on patients at least 2 min prior to venipuncture. All patients will also receive Lidocaine 2.5%/Prilocaine 2.5% cream at least 60 min prior to venipuncture.

Group II: no VR goggle with venipuncture Active Control 1 Intervention

Patients will receive Lidocaine 2.5%/Prilocaine 2.5% cream at least 60 min prior to venipuncture but NO virtual reality goggles.

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

Findings from Research

In a study involving 64 children aged 7 to 16 undergoing venous cannulation, the use of a three-dimensional virtual reality (VR) game as a distraction led to higher patient satisfaction compared to standard care, with 100% of children in the VR group preferring it for future procedures.

Although the VR intervention did not significantly reduce pain scores or procedural times compared to standard care, it was well-received and had a low incidence of adverse effects, suggesting it can be a valuable addition to pain management strategies for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immersive Virtual Reality for Pediatric Procedural Pain: A Randomized Clinical Trial. Walther-Larsen, S., Petersen, T., Friis, SM., et al.[2020]

A case study involving a 16-year-old patient with cerebral palsy showed that using virtual reality (VR) during physiotherapy sessions significantly reduced pain levels by 41.2% compared to sessions without VR.

This study suggests that VR can be an effective non-pharmacologic pain management strategy for children recovering from surgery, especially for those who may not tolerate traditional pain medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality as a pediatric pain modulation technique: a case study. Steele, E., Grimmer, K., Thomas, B., et al.[2011]

The INOVATE-Pain consortium, consisting of 16 experts, aims to improve the use of virtual reality (VR) and augmented reality (AR) in treating pediatric chronic pain by establishing best practices for designing and evaluating these interventions.

Key recommendations include fostering partnerships among stakeholders, standardizing outcome measures for evaluation, and ensuring access to resources, all of which are essential for developing effective VR-based pain management solutions for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leveraging Virtual Reality and Augmented Reality to Combat Chronic Pain in Youth: Position Paper From the Interdisciplinary Network on Virtual and Augmented Technologies for Pain Management. Logan, DE., Simons, LE., Caruso, TJ., et al.[2021]

The pilot trial demonstrated that using virtual reality (VR) during venipuncture significantly improved coping behaviors in children compared to a reference group without support, with a recruitment rate of 93% and successful documentation of coping behaviors.

While VR did not significantly reduce distress or pain ratings compared to other support methods, it showed promise as a feasible and effective tool for enhancing children's coping during medical procedures, warranting further research into its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric Coping During Venipuncture With Virtual Reality: Pilot Randomized Controlled Trial. Canares, T., Parrish, C., Santos, C., et al.[2021]

In a study involving 106 children aged 4-7 years undergoing venous cannulation, the use of a virtual reality (VR) game as a distraction did not significantly reduce pain compared to standard distraction methods using tablets or smartphones, with both groups reporting similar pain levels.

Patient satisfaction was high in both groups, and the study found no significant differences in procedural times or adverse effects, indicating that VR can be an acceptable distraction method but may not provide additional pain relief benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial on virtual reality distraction during venous cannulation in young children. Thybo, KH., Friis, SM., Aagaard, G., 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]

In a study involving 102 children aged 7-12, using virtual reality (VR) headsets during venipuncture significantly reduced post-procedure pain scores (1.46 vs. 4.44 in the control group), demonstrating VR's effectiveness in managing pain during invasive procedures.

The heart rate of children using VR was also significantly lower (99.27 bpm) compared to those who did not use VR (108.20 bpm), indicating that VR may help reduce anxiety and physiological stress during medical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Virtual Reality on Pain Experienced by School-Age Children During Venipuncture: A Randomized Controlled Study. Orhan, E., Gozen, D.[2023]

References

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

Immersive Virtual Reality for Pediatric Procedural Pain: A Randomized Clinical Trial. [2020]

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

Virtual reality as a pediatric pain modulation technique: a case study. [2011]

3. Canada pubmed.ncbi.nlm.nih.gov

Leveraging Virtual Reality and Augmented Reality to Combat Chronic Pain in Youth: Position Paper From the Interdisciplinary Network on Virtual and Augmented Technologies for Pain Management. [2021]

4. Canada pubmed.ncbi.nlm.nih.gov

Pediatric Coping During Venipuncture With Virtual Reality: Pilot Randomized Controlled Trial. [2021]

5. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial on virtual reality distraction during venous cannulation in young children. [2022]

6. 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]

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

The Effect of Virtual Reality on Pain Experienced by School-Age Children During Venipuncture: A Randomized Controlled Study. [2023]