Virtual Reality Goggles for Procedural Pain in Children

Recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether virtual reality goggles can reduce pain and anxiety in children and young adults during blood draws in a hospital setting. Participants will either use the VR goggles or receive standard care, which includes a numbing cream, before the procedure. The goal is to determine if the goggles make the experience less stressful. This trial suits children and young adults aged 5-21 who are hospitalized and scheduled for a morning blood draw. Participants should not have conditions like recent head surgery or migraines that would make wearing the goggles uncomfortable. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance hospital experiences for young patients.

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 prior data suggests that virtual reality goggles are safe for children during venipuncture?

Research has shown that virtual reality goggles are generally safe for children during medical procedures. Studies have found that these goggles can help reduce pain and anxiety in kids undergoing procedures like surgery or blood draws. In one study, children reported feeling less pain and anxiety when using virtual reality goggles compared to not using them.

Regarding safety, virtual reality goggles are well-tolerated. Most children handle the experience without issues. These studies have reported no serious side effects, suggesting that virtual reality is a safe tool to make medical procedures less stressful for children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using virtual reality goggles for managing procedural pain in children because they offer a unique, immersive distraction from the pain associated with procedures like venipunctures. Unlike traditional methods that rely solely on topical anesthetics like Lidocaine/Prilocaine cream, virtual reality goggles provide an engaging experience that can significantly reduce the perception of pain and anxiety. This innovative approach could revolutionize how we manage procedural pain by making the experience more comfortable for young patients without additional medications.

What evidence suggests that virtual reality goggles are effective for reducing procedural pain in children?

Research shows that virtual reality (VR) goggles can reduce pain and anxiety in children during medical procedures. In this trial, one group of participants will use VR goggles during venipuncture, while another group will not. One study found that children using VR during blood draws experienced significantly less pain than those without VR. Another study demonstrated that VR reduces anxiety and pain in children during various medical procedures. Additionally, children using VR reported less discomfort and stress. These findings suggest that VR goggles could be a valuable tool for making medical procedures less painful and stressful for children. ^{2 5 6 7 8}

Who Is on the Research Team?

Courtney A McNamara, MD

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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 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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31160472/

Immersive Virtual Reality for Pediatric Procedural Pain Our aim for this study is to investigate patient satisfaction and pain reduction by using a three-dimensional VR interactive game as a distraction.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6791566/

Systematic Review and Meta-analysis of Virtual Reality in ... This meta-analysis is the first to collate evidence on the effectiveness of VR on reducing pain and anxiety in pediatric patients undergoing medical procedures.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0882596325000697

Virtual reality for distraction during painful procedures in ... The study shows how VR affects the pain and anxiety of pediatric surgery patients. Children in the experimental group reported less pain and anxiety.

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2801490

Effects of an Immersive Virtual Reality Intervention on Pain ... In this randomized clinical trial of 149 pediatric patients undergoing venipuncture, an IVR intervention significantly improved patient-reported pain.

5. jmir.org jmir.org/2025/1/e68348

Virtual Reality for Pediatric Postoperative Pain Management Virtual reality (VR) has emerged as a promising nonpharmacological intervention for pediatric pain management, offering immersive, multisensory ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5532544/

Immersive Virtual Reality for Pediatric Pain - PMC In this paper, we review recent literature in pediatric virtual reality for procedural pain and anxiety, acute and chronic pain, and some rehabilitation ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03998995

Virtual Reality Distraction From Procedural Pain in Children IVR rehabilitation game experience will show less procedural pain, discomfort, and difficulties to movement, compared to usual physical therapy experiences. IVR ...

8. publications.aap.org publications.aap.org/hospitalpediatrics/article/9/7/501/26768/Immersive-Virtual-Reality-for-Pediatric-Procedural

Immersive Virtual Reality for Pediatric Procedural Pain Our aim for this randomized study was to investigate the efficacy and safety of VR distraction for decreasing pain in children aged 7 to 16 ...