Virtual Reality for Pediatric Dental Anxiety

No longer recruiting at 1 trial location

Overseen By Alexander Alcaraz, DMD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Must not be taking: Nitrous oxide, sedative drugs

Disqualifiers: Seizure disorders, developmental disabilities, 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: 2

Duration: 1 visit

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how virtual reality (VR) might reduce anxiety, improve behavior, and ease pain for children receiving dental sealants. Children will either use a VR headset to play games during the procedure or receive standard behavior guidance, then switch in a later visit to compare effects. It suits healthy children aged 6-18 who need two or more dental sealants and can comfortably wear VR goggles during their dental appointment. As an unphased trial, this study offers a unique opportunity for children to experience innovative technology that could enhance their 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. However, children who require sedative drugs or general anesthesia for dental treatment are excluded from the study.

What prior data suggests that this virtual reality technique is safe for children?

Research has shown that virtual reality (VR) is generally safe for reducing pain and anxiety in children during dental visits. In one study, children who used VR reported less anxiety and pain, with no major safety issues or side effects identified. Another study examined VR's ability to distract children during dental treatments to manage stress. It found that children handle VR well, effectively lowering anxiety without causing harm.

Additionally, a review of self-guided VR therapy highlighted its ease of use and acceptance by children, confirming its safety. While VR is a new tool in dental care, these studies show promising results, suggesting that VR can safely and effectively help children feel more comfortable during dental visits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using virtual reality (VR) to tackle pediatric dental anxiety because it offers a unique, immersive experience that goes beyond traditional methods like basic behavior guidance. Unlike standard techniques, which rely on verbal reassurance and distraction, the VR system engages children through interactive games featuring bright colors and cartoon-like characters, making dental visits more enjoyable. This innovative approach not only helps manage anxiety but also has the potential to transform the dental experience into something fun and engaging for kids, leading to better overall dental care outcomes.

What evidence suggests that virtual reality is effective for reducing dental anxiety in children?

Research shows that virtual reality (VR), which participants in this trial may experience, can help reduce anxiety and pain for kids during dental visits. Studies have found that VR technology calms children and lessens their pain. One study confirmed that immersive VR significantly reduces pain, as measured by the FLACC scale. Another study found that VR effectively lowers anxiety in children during dental visits. Although more research is needed to understand its long-term effects, current findings are promising. ^{1 2 4 6 7}

Who Is on the Research Team?

Carla Angela Alvarez, DMD

Principal Investigator

Herman Ostrow School of Dentistry Pediatric Department

Are You a Good Fit for This Trial?

This trial is for children aged 6-18 who need at least two dental sealants and are healthy (ASA I or II). They must be comfortable with wearing VR goggles without discomfort, dizziness, or motion sickness. Kids with seizures, developmental disabilities, significant cognitive disorders, or those needing sedation for treatment are excluded.

Inclusion Criteria

I am between 6 and 18 years old.

ASA I or II

I need at least two dental sealants, one for each half of my mouth, determined during a dental exam.

Exclusion Criteria

Children who wear glasses and are unable to comfortably adjust the system over their glasses

My child needs medication to undergo dental procedures.

My child has a developmental disability.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo dental sealant application with either virtual reality distraction or basic behavior guidance techniques

1 visit

1 visit (in-person)

Post-Operative Observation

Participants are observed for changes in anxiety, behavior, and pain immediately after treatment

5 minutes

1 visit (in-person)

Follow-up

Participants are monitored for satisfaction and any delayed reactions post-treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality

Trial Overview The study tests if virtual reality can reduce anxiety and pain during dental procedures compared to basic behavior guidance techniques. Using a split-mouth cross-over design, each child experiences both methods in random order while getting dental sealants.

How Is the Trial Designed?

Group I: Virtual Reality Experimental Treatment 1 Intervention

The virtual reality system being used for research purposes is the RelievRx by AppliedVR which is an immersive virtual reality device that includes a goggle headset and remote control. The VR experience will be an immersive experience where the child will interact with the system and navigate their way through a game that will involve bright colors, cartoon-like characters, and settings with age-appropriate content.

Group II: Basic Behavior Guidance Techniques Active Control 1 Intervention

The control sample will include basic behavior guidance techniques and is standard of care. The use of basic behavior guidance techniques is common in pediatric dentistry and is not unique to this study.

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

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 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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10809031/

The Effectiveness of Virtual Reality in Controlling Pain and ... This cohort study explores the use of VR technology in reducing anxiety and pain perception during dental procedures for children.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40611601/

Evaluating the Effectiveness of Virtual Reality in Reducing ... VR shows promise for reducing dental anxiety and improving treatment outcomes, though additional research is needed to assess its long-term effects.

3. jomos.org jomos.org/articles/mbcb/full_html/2024/02/mbcb240052/mbcb240052.html

Does immersive virtual reality reduce pain and anxiety in ... Our work confirms the very recent interest of immersive VR in reducing pain and anxiety in pediatric dentistry.

4. frontiersin.org frontiersin.org/journals/oral-health/articles/10.3389/froh.2025.1539018/full

Effect of immersive virtual reality on pain in different dental ... Results confirmed that VR distraction significantly reduced pain perception, as measured by the FLACC scale, regardless of whether local ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05898100

Virtual Reality Distraction for Dental Anxiety (PILOT) A recent clinical trial by Alshatrat et al (2022) concluded that VR is an effective tool in reducing anxiety in young children during dental procedures.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05898100

Virtual Reality Distraction for Dental Anxiety (PILOT) It aims at reducing anxiety in children aged 6 to 17 years old by mean of immersive distraction. ... The primary outcome will be assessment of dental fear and ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1386505625001194

Review article Self-guided virtual reality therapy for anxiety This systematic review aimed to examine the effectiveness and user experience (i.e., usability, acceptability, safety, and attrition rates) of self-guided VR ...