Virtual Reality for Pediatric Dental Anxiety

Overseen By Beatriz Ferraz dos Santos, DDS, MSc

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Must not be taking: Benzodiazepines

Disqualifiers: Cognitive impairment, Epilepsy, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

128 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether virtual reality (VR) can reduce pain and anxiety in children during dental procedures. One group will use VR headsets for distraction, while the other group will receive standard care. Both groups will report their feelings about pain and anxiety before and after treatment. Children aged 6 to 12, who understand English or French and are scheduled for specific dental procedures, may be suitable for this trial.

As an unphased trial, this study provides a unique opportunity to explore innovative methods to enhance comfort during dental visits.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this virtual reality technique is safe for pediatric dental use?

Research has shown that using virtual reality (VR) during dental visits is generally safe for children. One study found that VR reduced pain and anxiety during dental treatments. Another study demonstrated that VR managed children's behavior by lowering anxiety and fear. These studies reported no major side effects, suggesting that VR is well-tolerated.

While these studies show promising results, it's important to remember that every child is different. Some children might need time to adjust to the headset, but overall, VR appears to be a safe way to make dental visits less stressful. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using virtual reality (VR) for pediatric dental anxiety because it offers a unique, immersive experience that can effectively distract children during dental procedures. Unlike traditional behavior management techniques, like tell-show-do and positive reinforcement, VR provides a fully engaging environment that can help reduce stress and anxiety by transporting kids to a different world. This method has the potential to make dental visits less intimidating and more comfortable for young patients, which could lead to better cooperation and outcomes during dental care.

What evidence suggests that using Virtual Reality is effective for reducing pediatric dental anxiety?

Research has shown that virtual reality (VR), which participants in this trial may receive, can help reduce anxiety and pain for children during dental visits. Studies have found that VR makes kids feel less anxious and reduces their pain during dental procedures. In one study, children who used VR reported feeling calmer and experiencing less pain. Another study highlighted VR's growing popularity as a tool to manage children's fear of the dentist. Overall, evidence suggests that VR could be a promising way to make dental visits less stressful for kids. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for children who experience dental anxiety during procedures. To participate, they must be undergoing a dental treatment and willing to use a VR headset or follow standard care. There are no specific exclusion criteria provided.

Inclusion Criteria

My child can understand and speak French or English.

My child is scheduled for dental work like fillings, crowns, pulp therapy, or extractions.

I am a child aged 6-12, or I am their parent/legal guardian.

Exclusion Criteria

My child cannot play VR games due to epilepsy or another condition.

My child needs urgent dental care.

My child needs dental work with sedation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive dental treatment with or without the use of a Virtual Reality headset as a distraction technique

1 day

1 visit (in-person)

Follow-up

Participants are monitored for their perception of pain and anxiety, and satisfaction with the dental treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality

Trial Overview

The study tests if using Virtual Reality headsets can help manage kids' anxiety during dental visits compared to the usual behavior management techniques. It's a randomized trial where participants are split into two groups: one with VR distraction and one without.

How Is the Trial Designed?

Group I: Pediatric dental treatment using VR Experimental Treatment 1 Intervention

At the beginning of the dental visit, subjects enrolled in the virtual reality (VR) group (n=64) will receive instructions about how to operate the VR system. The research team will then properly fit VR headset onto the child's head and ensure that there are no discomforts. Then, the research team will monitor the intervention using the tablet interface, allowing them to start, pause, and stop the VR intervention. The child will be given 5 minutes to get used to the device. During this time, any adjustments to the headset will be made. The VR intervention will last the duration of the dental procedure, unless told otherwise by the patient, their parent/legal-guardian, or the research team. The entire VR intervention will be closely monitored for any adverse events. Time of play and the patients' compliance of using VR will be noted.

Group II: Control group Active Control 1 Intervention

Subjects enrolled in the control group (n=64) will receive their dental care using the behavior management techniques recommended by the American Academy of Pediatric Dentistry (i.e., tell-show-so, communicative guidance, distraction through stories and positive reinforcement).

Virtual Reality is already approved in United States for the following indications:

Approved in United States as Virtual Reality Therapy for:

• Functional Dyspepsia
• Irritable Bowel Syndrome (IBS)
• Gastroparesis

Who Is Running the Clinical Trial?

McGill University Health Centre/Research Institute of the McGill University Health Centre

Lead Sponsor

Trials

476

Recruited

170,000+

Published Research Related to This Trial

A systematic review of 22 randomized control trials found that virtual reality (VR) is highly effective in managing anxiety and pain in children during dental procedures, outperforming traditional behavioral control techniques.

VR provides an engaging distraction that helps young patients feel more comfortable and satisfied during treatments, but further research is needed to fully understand its potential in pediatric dentistry.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality and behaviour management in paediatric dentistry: a systematic review. Barros Padilha, DX., Veiga, NJ., Mello-Moura, ACV., et al.[2023]

A systematic review of 12 randomized controlled trials involving 818 pediatric patients found that virtual reality (VR) distraction interventions significantly reduced dental anxiety, pain, and heart rate during dental treatments, indicating their effectiveness as a management tool.

Despite the positive results, the evidence for VR's effectiveness in reducing dental anxiety may be weakened by publication bias, highlighting the need for more high-quality studies to confirm these findings and optimize VR delivery in dental settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of virtual reality distraction interventions to reduce dental anxiety in paediatric patients: A systematic review and meta-analysis. Yan, X., Yan, Y., Cao, M., et al.[2023]

In a study involving 80 children aged 5 to 10, the use of a VR headset during dental treatment significantly reduced anxiety, with 95% of the children reporting happiness compared to only 40% in the control group.

The VR headset also improved behaviour during treatment, achieving 100% positive behaviour in the VR group versus 57.5% in the control group, demonstrating its effectiveness as a distraction technique for non-cooperative paediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behaviour and Anxiety Management of Paediatric Dental Patients through Virtual Reality: A Randomised Clinical Trial. Gómez-Polo, C., Vilches, AA., Ribas, D., et al.[2021]

This study investigates the efficacy of Virtual Reality Exposure Therapy (VRET) for dental phobia, comparing it to an informational pamphlet control group, with 30 participants aged 18-50 and follow-ups at 1 week, 3 months, and 6 months.

The study aims to measure reductions in dental anxiety and physiological arousal (heart rate) during VRET, potentially establishing VRET as a non-invasive alternative treatment for dental anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of virtual reality exposure therapy for treatment of dental phobia: a randomized control trial. Raghav, K., Van Wijk, AJ., Abdullah, F., et al.[2022]

In a study involving 40 children aged 4 to 8 years, the use of virtual reality (VR) eyeglasses during pulp therapy significantly reduced both pain perception and anxiety levels, with statistical significance (P < 0.001).

The findings suggest that VR technology could be a beneficial tool for pediatric dentists to improve the experience of young patients during dental procedures, although further research is needed to confirm these results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of distraction using virtual reality technology on pain perception and anxiety levels in children during pulp therapy of primary molars. Niharika, P., Reddy, NV., Srujana, P., et al.[2022]

A review of nine randomized clinical trials found that using virtual reality (VR) glasses during dental treatment significantly improved children's behavior and reduced their pain perception, particularly during restorative procedures.

Despite the positive effects on behavior and pain perception, VR glasses did not significantly reduce anxiety levels during procedures like local anesthesia or the use of rubber dams.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Virtual Reality Glasses as a Distraction for Children During Dental Care. Custódio, NB., Costa, FDS., Cademartori, MG., et al.[2020]

The study evaluated the effectiveness of virtual reality as a distraction technique during local anesthesia administration in 50 pediatric patients aged 6 to 12, finding that those using virtual reality had higher heart rates during the procedure compared to the control group, indicating increased anxiety levels.

Younger children and females reported higher pain scores regardless of the distraction method, suggesting that these demographics may require additional pain management strategies during dental procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of virtual reality distraction on pain and anxiety during infiltration anesthesia in pediatric patients: a randomized clinical trial. Felemban, OM., Alshamrani, RM., Aljeddawi, DH., et al.[2022]

In a study involving 120 healthy children aged 4-6 years, the use of virtual reality eyeglasses during dental procedures significantly reduced both pain perception and anxiety levels, with results showing a P-value of less than 0.001 for both measures.

The findings suggest that virtual reality is an effective tool for managing pain and anxiety in pediatric dental patients, enhancing their overall treatment experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Virtual Reality Distraction on Pain and Anxiety during Dental Treatment in 4-6 Year-Old Children: a Randomized Controlled Clinical Trial. Asl Aminabadi, N., Erfanparast, L., Sohrabi, A., et al.[2022]

This pilot study will evaluate the feasibility and acceptability of using virtual reality (VR) to reduce dental fear and anxiety (DFA) in pediatric patients with special health care needs during dental procedures, involving 20 participants randomized into two groups.

The study aims to assess patient recruitment and completion rates, as well as physiological and behavioral indicators of anxiety, providing a foundation for future research on VR in pediatric dentistry.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Virtual Reality Game on Children's Anxiety During Dental Procedures (VR-TOOTH): Protocol for a Pilot Randomized Controlled Trial. Wu, W., Le May, S., Hung, N., et al.[2023]

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