128 Participants Needed

Virtual Reality for Pediatric Dental Anxiety

BF
Overseen ByBeatriz 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
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The use of virtual reality (VR) in pediatric healthcare settings helps to reduce children's pain and anxiety. However, this technology has not been used consistently in pediatric dentistry. Consequently, the goal of this study is to investigate the effectiveness of using a Virtual Reality headset as a distraction technique during dental procedures in children and identify patient and clinician's opinions regarding its use.This study incorporates a single-site, randomized clinical trial design with two paralleled study groups. One group will receive dental treatment following regular standard of care of behavior management while the second group will receive dental treatment using a Virtual Reality distraction headset. Patients in both groups will complete a questionnaire to assess their perception of pain and anxiety before and after the intervention, as well as their satisfaction with the dental treatment. The dentist providing the treatment will also report their observations relating to patient behavior during dental treatment.

Will I have to stop taking my current medications?

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

Is virtual reality safe for children during dental treatments?

Research shows that using virtual reality (VR) glasses or headsets is generally safe for children during dental treatments. It helps reduce anxiety and improve behavior without any reported safety concerns.12345

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

Virtual reality 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.13467

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.23489

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.
See 1 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Pediatric dental treatment using VRExperimental Treatment1 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 groupActive Control1 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

Find a Clinic Near You

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 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.
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 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.
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]
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.
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]

Citations

Effectiveness of virtual reality distraction interventions to reduce dental anxiety in paediatric patients: A systematic review and meta-analysis. [2023]
Effects of distraction using virtual reality technology on pain perception and anxiety levels in children during pulp therapy of primary molars. [2022]
Behaviour and Anxiety Management of Paediatric Dental Patients through Virtual Reality: A Randomised Clinical Trial. [2021]
Effectiveness of Virtual Reality Glasses as a Distraction for Children During Dental Care. [2020]
Efficacy of virtual reality exposure therapy for treatment of dental phobia: a randomized control trial. [2022]
Virtual reality and behaviour management in paediatric dentistry: a systematic review. [2023]
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]
Effects of a Virtual Reality Game on Children's Anxiety During Dental Procedures (VR-TOOTH): Protocol for a Pilot Randomized Controlled Trial. [2023]
Effect of virtual reality distraction on pain and anxiety during infiltration anesthesia in pediatric patients: a randomized clinical trial. [2022]
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