Virtual Reality for Pediatric Dental Anxiety

Recruiting at1 trial location

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Southern California

Must not be taking: Nitrous oxide, sedative drugs

Disqualifiers: Seizure disorders, developmental disabilities, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial investigates if using a VR headset with interactive games can reduce anxiety and pain in children aged 6-18 during dental sealant procedures. The VR system aims to distract children, making them less aware of the procedure and more comfortable. Virtual reality (VR) has been shown to effectively reduce anxiety and pain in children during various dental procedures.

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 data supports the effectiveness of the treatment Virtual Reality Therapy for reducing dental anxiety in children?

Research shows that using virtual reality (VR) headsets during dental treatment can significantly reduce anxiety and improve behavior in children. In one study, 95% of children using VR were happy, and 100% showed positive behavior, compared to lower rates in those not using VR. ^{1 2 3 4 5}

Is virtual reality safe for children during dental treatments?

Research shows that using virtual reality (VR) for children during dental treatments is generally safe. It helps reduce anxiety and improve behavior without any reported safety concerns. ^{1 3 5 6 7}

How does virtual reality treatment differ from other treatments for pediatric dental anxiety?

Virtual reality (VR) treatment is unique because it uses immersive and interactive environments to distract children during dental procedures, reducing anxiety and improving their experience without the need for medication. Unlike traditional methods that may rely on drugs, VR provides a nonpharmacologic option that engages the senses to manage anxiety and pain. ^{1 5 6 8 9}

Research Team

Carla Angela Alvarez, DMD

Principal Investigator

Herman Ostrow School of Dentistry Pediatric Department

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Virtual Reality (Behavioural Intervention)

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.

Participant Groups

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+

Dr. Samir A.

University of Southern California

Chief Executive Officer since 2024

PhD in Molecular Biology from the University of Southern California

Dr. Chung

University of Southern California

Chief Medical Officer since 2016

MD from UC San Diego

Findings from Research

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 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]

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]

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]

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]

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]

References

1. India 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. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Effectiveness of virtual reality distraction interventions to reduce dental anxiety in paediatric patients: A systematic review and meta-analysis. [2023]

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

Behaviour and Anxiety Management of Paediatric Dental Patients through Virtual Reality: A Randomised Clinical Trial. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Efficacy of virtual reality exposure therapy for treatment of dental phobia: a randomized control trial. [2022]

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

Effectiveness of Virtual Reality Glasses as a Distraction for Children During Dental Care. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Virtual reality and behaviour management in paediatric dentistry: a systematic review. [2023]

7. Iran 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. [2022]

8. Canada 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. [2023]

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

Effect of virtual reality distraction on pain and anxiety during infiltration anesthesia in pediatric patients: a randomized clinical trial. [2022]