Virtual Reality for Dental Anxiety

Overseen By Sylvie Le May, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: St. Justine's Hospital

Disqualifiers: Epilepsy, Hand paralysis, Eye disease, 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 day per procedure

88 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems focused on using VR for dental anxiety, so it's unlikely that your medications would be affected, but you should confirm with the trial organizers.

What data supports the idea that Virtual Reality for Dental Anxiety is an effective treatment?

The available research shows that Virtual Reality (VR) is effective in reducing dental anxiety. One study found that 65% of patients undergoing dental extractions found VR to be extremely or quite beneficial in reducing anxiety, with 87.5% wanting to use VR again. Another study suggests that VR is more effective than watching television for distraction during dental procedures. Additionally, VR has been shown to reduce anxiety and pain in oral surgery, although more studies are needed to confirm these findings. Overall, VR appears to be a promising tool for managing dental anxiety. ^{1 2 3 4 5}

What safety data exists for using virtual reality to treat dental anxiety?

The studies reviewed indicate that virtual reality (VR) is a promising tool for reducing dental anxiety and pain. VR has been used effectively as a distraction technique during dental procedures, showing positive outcomes in both subjective measures (like self-reported anxiety and pain) and objective measures (such as heart rate). The research suggests VR is safe and beneficial for patients with mild to moderate dental anxiety, including pediatric patients. However, specific safety data or adverse effects are not detailed in the provided abstracts. ^{1 2 3 6 7}

Is Virtual Reality Distraction a promising treatment for dental anxiety?

Yes, Virtual Reality Distraction is a promising treatment for dental anxiety. Research shows that it can help reduce anxiety and pain during dental procedures. Many patients find it beneficial, and it is especially helpful for young adults and those with moderate anxiety. Virtual Reality offers a fun and engaging way to distract patients, making dental visits less stressful. ^{4 5 6 8 9}

What is the purpose of this trial?

The aim of this randomized clinical trial is to verify the efficacy of VR immersion over a muted cartoon on a wall-mounted TV to decrease dental fear and anxiety of children undergoing dental procedures. The study also aims to gain insight on the satisfaction of parents and healthcare providers on the use of VR during dental appointments. Main research question: Does VR immersion compare to a cartoon on a wall-mounted TV is more efficacious to decrease dental fear and anxiety of children requiring dental procedures? Participants will be playing through a VR immersive game wearing a eye-tracking VR headset that requires no movement of the head to play, facilitating the dental procedure. The investigators will take measures of the stress levels of participants and their parents using a validated stress scale and also by taking salivary samples to verify the levels of a stress biomarker (alpha-amylase).

Research Team

Sylvie Le May, PhD

Principal Investigator

St. Justine's Hospital

Eligibility Criteria

This trial is for children who experience dental fear and anxiety when facing dental procedures. To join, they must have a condition related to oral health or have suffered a traumatic dental injury. Children with certain medical conditions that could interfere with the study or those who cannot use VR due to other reasons are not eligible.

Inclusion Criteria

I am between 6 and 17 years old.

Received the dentist's recommendation to participate

I need to have a dental procedure done.

Exclusion Criteria

Any other conditions preventing them from using virtual reality (VR) (e.g., epidermolysis bullosa)

I have weakness or paralysis in my hand.

I have epilepsy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo dental procedures with either VR immersion or watching a muted cartoon on a wall-mounted TV to assess anxiety reduction

1 day per procedure

1 visit (in-person)

Follow-up

Participants are monitored for satisfaction and physiological parameters immediately after the dental procedure

Immediate post-procedure

1 visit (in-person)

Data Collection and Analysis

Data on anxiety levels, satisfaction, and physiological parameters are collected and analyzed

Ongoing throughout the trial

Treatment Details

Interventions

• Virtual Reality Distraction

Trial Overview The trial is testing if using Virtual Reality (VR) games during dental visits can help reduce fear and anxiety in children more effectively than watching cartoons on TV. Kids will wear an eye-tracking VR headset that doesn't require head movement, making it easier for dentists to work.

Participant Groups

Group I: Virtual Reality Distraction Experimental Treatment 1 Intervention

Use of virtual reality (VR) during dental procedure.

Group II: Standard Treatment Active Control 1 Intervention

Dental Clinic's standard treatment during dental procedure.

Who Is Running the Clinical Trial?

St. Justine's Hospital

Lead Sponsor

Trials

205

Recruited

87,300+

Findings from Research

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 randomized controlled trial aims to assess whether virtual reality (VR) can enhance the dental experience for patients undergoing procedures like fillings or extractions, particularly focusing on how it affects their memories of pain and anxiety one week post-treatment.

The study will compare the effectiveness of VR environments—natural versus urban—against standard care, potentially revealing whether VR can help reduce anxiety and improve recollections of dental visits, especially for patients with higher levels of dental anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can virtual nature improve patient experiences and memories of dental treatment? A study protocol for a randomized controlled trial. Tanja-Dijkstra, K., Pahl, S., White, MP., et al.[2022]

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 50 patients undergoing dental extractions, 65% reported that virtual reality (VR) significantly reduced their anxiety levels during the procedure, with 87.5% expressing a desire to use VR again in the future.

The most pronounced benefits of VR were observed in young adults (ages 18-35), males, patients with moderate anxiety, and those undergoing surgical extractions, suggesting that VR could be particularly effective for these groups in dental settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' perceptions of the benefits of virtual reality during dental extractions. Ougradar, A., Ahmed, B.[2020]

The use of virtual reality (VR) headsets in oral surgery has shown promise in significantly reducing both pre-operative and post-operative anxiety and pain, based on a review of 6 relevant studies.

While the initial findings are encouraging, indicating that VR can be an effective non-drug technique for managing patient discomfort, further research is necessary to fully confirm its effectiveness in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contribution of virtual reality in oral surgery: A literature review. Falguière, A., LeGruiec, C., Herry, H., et al.[2021]

Virtual reality (VR) has been shown to effectively reduce pain and anxiety in patients undergoing dental treatments, particularly in children, with a significant effect size of -0.82 for pain reduction based on a meta-analysis of 10 studies.

Despite its effectiveness in pediatric patients, there is a need for more research on the use of VR for adults and its potential as a preparatory tool for dental treatments, as current studies are limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Virtual Reality for the Management of Anxiety and Pain in Dental Treatments: Systematic Review and Meta-Analysis. López-Valverde, N., Muriel Fernández, J., López-Valverde, A., et al.[2020]

Patients using virtual reality (VR) during dental procedures reported significantly lower levels of anxiety and pain, as indicated by self-evaluation questionnaires.

Physiological data also supported these findings, showing a decrease in anxiety levels, suggesting that VR can effectively distract and reduce discomfort for patients with mild to moderate fear and anxiety during dental treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical use of virtual reality distraction system to reduce anxiety and pain in dental procedures. Wiederhold, MD., Gao, K., Wiederhold, BK.[2022]

A review of 27 studies found that virtual reality (VR) is effective in reducing pain and anxiety during dental and oral surgery procedures, with a significant increase in research on this topic from 2011 to 2021.

Most studies focused on dental procedures, indicating a need for more research in oral and maxillofacial surgery, where VR could potentially enhance patient care by managing anxiety and pain more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Virtual Reality to Reduce Pain and Anxiety in Surgical Procedures of the Oral Cavity: A Scoping Review. Martinez-Bernal, D., Vidovich, C., Keenan, C., 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. 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]

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

Can virtual nature improve patient experiences and memories of dental treatment? A study protocol for a randomized controlled trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

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

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

Patients' perceptions of the benefits of virtual reality during dental extractions. [2020]

5. France pubmed.ncbi.nlm.nih.gov

Contribution of virtual reality in oral surgery: A literature review. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Use of Virtual Reality for the Management of Anxiety and Pain in Dental Treatments: Systematic Review and Meta-Analysis. [2020]

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

Clinical use of virtual reality distraction system to reduce anxiety and pain in dental procedures. [2022]

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

The Use of Virtual Reality to Reduce Pain and Anxiety in Surgical Procedures of the Oral Cavity: A Scoping Review. [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]