Virtual Reality Exposure for Dental Phobia

Overseen By Jennifer Piscitello, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: New York University

Disqualifiers: Mental disorders, Balance disorders, Epileptic seizures, Cardiac problems, 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

250 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment neVR Fear the Dentist, Virtual Reality Exposure for Dental Fear?

Research shows that virtual reality (VR) can help reduce anxiety and pain during dental treatments. Studies found that VR is beneficial in lowering anxiety levels in patients, with many expressing a desire to use it again in future dental visits. ^{1 2 3 4 5}

Is virtual reality exposure therapy safe for humans?

Virtual reality exposure therapy (VRET) has been studied for various phobias and anxiety conditions, and it is generally considered safe for humans. The studies reviewed did not report any significant safety concerns, suggesting that VRET is a safe treatment option. ^{4 6 7 8 9}

How is the treatment 'neVR Fear the Dentist' different from other treatments for dental phobia?

The 'neVR Fear the Dentist' treatment uses Virtual Reality Exposure Therapy (VRET), which is unique because it allows patients to face their dental fears in a virtual environment, potentially reducing anxiety without the need for real-life exposure. This method can be administered by non-specialists, making it a cost-effective alternative to traditional therapies. ^{1 3 4 10 11}

What is the purpose of this trial?

The purpose of this study is to compare an intervention for dental fear to the usual approach (i.e., whatever your dentist typically does to help you manage fear) in reducing patient fear and making dentist appointments more tolerable. The dental fear intervention (called neVR Fear the Dentist™) has two separate steps. Step 1 involves using a mobile app that is based on research-backed approaches to handling dental fear on your smartphone or device. Step 2 is a 1-hour self-administered virtual reality intervention to be completed in the dental office. This is a randomized study. Participants will be randomized to either the intervention group or an active control. Investigators hypothesize that participants in the intervention condition will show greater declines in self-reported dental fear and improved oral health-related quality of life during post-treatment and follow-up period.

Research Team

Richard Heyman, PhD

Principal Investigator

New York University

Eligibility Criteria

This trial is for individuals with dental phobia. Participants should be willing to use a mobile app and undergo a virtual reality experience at the dentist's office. There are no specific inclusion or exclusion criteria provided, so it's open to anyone who struggles with fear of dental visits.

Inclusion Criteria

Be able and willing to comply with study procedures

Provide a signed and dated informed consent form an/or assent form (if applicable)

Proficient in English because the intervention is in English

Exclusion Criteria

I have a history of heart issues.

Are in pain, require urgent care, or whose necessary treatment will be delayed by participating in the study

I have a hearing or visual impairment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants use a mobile app for dental fear management followed by a 1-hour self-administered virtual reality intervention in the dental office

1-2 weeks

1 visit (in-person) for VR intervention

Follow-up

Participants are monitored for changes in dental fear and anxiety at multiple intervals post-treatment

6 months

Assessments at 1, 3, and 6 months post-treatment

Treatment Details

Interventions

• neVR Fear the Dentist

Trial Overview The study tests 'neVR Fear the Dentist™', which includes an app and a virtual reality session, against standard methods used by dentists to manage patient fear. The goal is to see if this new approach better reduces fear and improves patients' experiences.

Participant Groups

Group I: VRET Intervention Experimental Treatment 1 Intervention

Group II: Active Control Active Control 1 Intervention

neVR Fear the Dentist is already approved in United States for the following indications:

Approved in United States as neVR Fear the Dentist for:

• Dental fear
• Dental anxiety

Who Is Running the Clinical Trial?

New York University

Lead Sponsor

Trials

249

Recruited

229,000+

Virtually Better, Inc.

Industry Sponsor

Trials

10

Recruited

1,000+

Findings from Research

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]

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]

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]

In a study involving 200 children, immersive virtual reality (IVR) significantly reduced perceived pain and anxiety during dental procedures compared to non-immersive virtual reality (NIVR), with post-operative pain scores showing a notable difference (IVR: 0.75 vs. NIVR: 2.72 on the VAS scale).

The results suggest that IVR can be an effective distraction technique during dental treatments, making it a valuable addition to traditional methods for managing children's anxiety and pain during procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immersive and Non-Immersive Virtual Reality Distraction on Pain Perception to Intraoral Injections. Kumari, S., Bahuguna, R., Garg, N., et al.[2022]

A meta-analysis of 14 clinical trials showed that virtual reality exposure therapy (VRET) significantly improves behavioral assessments in patients with specific phobias, with a strong effect size of g = 1.23 after treatment.

VRET was found to be as effective as traditional in vivo exposure therapy, indicating that it can produce meaningful behavior changes in real-life situations, making it a valuable treatment option for specific phobias.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can virtual reality exposure therapy gains be generalized to real-life? A meta-analysis of studies applying behavioral assessments. Morina, N., Ijntema, H., Meyerbröker, K., et al.[2018]

Virtual reality exposure therapy (VRET) effectively helped all 14 patients overcome their fear of driving, with 71% demonstrating adequate driving behavior in real traffic after treatment.

The therapy not only reduced driving avoidance but also alleviated symptoms of posttraumatic stress disorder, indicating its potential for broader psychological benefits beyond just driving fear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating patients with driving phobia by virtual reality exposure therapy - a pilot study. Kaussner, Y., Kuraszkiewicz, AM., Schoch, S., et al.[2020]

A meta-analysis of 21 studies involving 300 subjects showed that virtual reality exposure therapy (VRET) leads to significant reductions in anxiety symptoms, indicating its efficacy as a treatment for anxiety and specific phobias.

The variability in reporting across studies limits the ability to analyze factors that may influence treatment outcomes, suggesting a need for more standardized research practices in future VRET studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Affective outcomes of virtual reality exposure therapy for anxiety and specific phobias: a meta-analysis. Parsons, TD., Rizzo, AA.[2008]

Virtual reality exposure therapy (VRET) was found to be more effective than no treatment for patients with panic disorder and agoraphobia, indicating its potential as a therapeutic intervention.

There was no significant difference in treatment outcomes between VRET delivered through a head-mounted display (HMD) and a computer automatic virtual environment (CAVE), suggesting that both methods are equally effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality exposure treatment of agoraphobia: a comparison of computer automatic virtual environment and head-mounted display. Meyerbröker, K., Morina, N., Kerkhof, G., et al.[2011]

A study involving 30 patients with dental phobia demonstrated that Virtual Reality Exposure Therapy (VRET) significantly reduced anxiety levels compared to an informational pamphlet, with notable improvements measured at multiple time points including 1-week, 3-months, and 6-months follow-up.

The VRET group showed substantial reductions in anxiety scores across various measures (e.g., VAS-A, MDAS, DFS), while the control group did not experience any significant changes, indicating VRET's efficacy as a treatment for dental phobia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of virtual reality exposure therapy for the treatment of dental phobia in adults: A randomized controlled trial. Gujjar, KR., van Wijk, A., Kumar, R., et al.[2020]

Virtual Reality Exposure Therapy (VRET) has been successfully applied to treat dental phobia in two case studies involving female patients aged 56 and 24, showing its potential effectiveness in reducing dental anxiety.

VRET can be administered by non-specialists, such as dental assistants, making it a cost-effective option for treating dental phobia, which could improve access to care for patients with this fear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality Exposure Therapy for Treatment of Dental Phobia. Gujjar, KR., Sharma, R., Jongh, AD.[2018]

References

1. 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]

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

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

3. 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]

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

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

5. Singapore pubmed.ncbi.nlm.nih.gov

Immersive and Non-Immersive Virtual Reality Distraction on Pain Perception to Intraoral Injections. [2022]

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

Can virtual reality exposure therapy gains be generalized to real-life? A meta-analysis of studies applying behavioral assessments. [2018]

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

Treating patients with driving phobia by virtual reality exposure therapy - a pilot study. [2020]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Affective outcomes of virtual reality exposure therapy for anxiety and specific phobias: a meta-analysis. [2008]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Virtual reality exposure treatment of agoraphobia: a comparison of computer automatic virtual environment and head-mounted display. [2011]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy of virtual reality exposure therapy for the treatment of dental phobia in adults: A randomized controlled trial. [2020]

11. England pubmed.ncbi.nlm.nih.gov

Virtual Reality Exposure Therapy for Treatment of Dental Phobia. [2018]