Virtual Reality Exposure for Dental Phobia

Overseen By Jennifer Piscitello, Ph.D

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help individuals with dental anxiety using a virtual reality tool called neVR Fear the Dentist™. The trial compares this tool to standard methods used by dentists to ease patient fears. Participants will either use the virtual reality tool or follow the usual dental approach. Individuals who frequently experience anxiety at dental appointments and own a smartphone or tablet may be suitable for this study. The goal is to determine if the virtual reality method can reduce fear and improve perceptions of dental health. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could transform dental care experiences.

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 prior data suggests that this virtual reality intervention is safe for dental phobia?

Research shows that virtual reality exposure therapy (VRET), such as the "neVR Fear the Dentist" program, is generally easy for patients to handle. Studies have used VRET to help people with dental anxiety, and it has significantly reduced fear without causing major side effects.

One study found that virtual reality glasses lowered both pain and anxiety during dental treatments. Another study highlighted that this therapy is non-invasive, meaning it doesn't physically enter the body, making it a safe option for those afraid of dental procedures.

Overall, using virtual reality to manage dental fear appears to be a safe choice based on current research. Significant negative effects have not been reported, so it might be worth considering for those nervous about dental visits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Virtual Reality Exposure Therapy (VRET) for dental phobia because it offers a new way to tackle anxiety without medication or traditional therapy sessions. Unlike standard options like cognitive-behavioral therapy or anti-anxiety medications, VRET immerses patients in a controlled virtual environment that mimics dental scenarios. This method allows individuals to gradually overcome their fears in a safe and engaging setting, which can be more appealing and less intimidating. Plus, it has the potential to provide quicker relief from anxiety compared to traditional methods, making it a promising option for those who dread the dentist.

What evidence suggests that this virtual reality intervention is effective for dental phobia?

Research has shown that Virtual Reality Exposure Therapy (VRET), which participants in this trial may receive, can help reduce dental anxiety. In one study, 85% of patients no longer feared the dentist six months after using VRET. Another study found that VRET lessens pain and anxiety during dental treatments, especially for children. This therapy uses virtual reality to gradually and safely expose patients to their fears, helping them become less afraid over time. Overall, VRET appears to be a promising, non-invasive treatment for those with dental anxiety. ^{1 2 3 6 7}

Who Is on the Research Team?

Richard Heyman, PhD

Principal Investigator

New York University

Are You a Good Fit for This Trial?

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

Report dental fear of 4 or higher on a scale of 0-9 on the Gatchel dental fear item

Be able and willing to comply with study procedures

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

Exclusion Criteria

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

I have a history of heart issues.

I have a hearing or visual impairment.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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]

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 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 (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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28903790/

Virtual Reality Exposure Therapy for the Treatment of ... Efficacy of VRET was evaluated by comparing the reduction in dental anxiety scores (measured 16 times within a 14-week study period, and at ...

2. withpower.com withpower.com/trial/phase-fear-dental-7-2024-1392b

Virtual Reality Exposure for Dental Phobia Virtual reality (VR) has been shown to effectively reduce pain and anxiety in patients undergoing dental treatments, particularly in children, with a ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0887618518301610

Efficacy of virtual reality exposure therapy for the treatment ... VRET seems to be an effective treatment for dental phobia. Six months after VRET, 85% of patients had lost their dental phobia diagnosis.

4. bmcoralhealth.biomedcentral.com bmcoralhealth.biomedcentral.com/articles/10.1186/s12903-016-0186-z

Efficacy of virtual reality exposure therapy for treatment of ... This study uses novel non-invasive VRET, which may provide a possible alternative treatment for dental anxiety and phobia.

5. isrctn.com isrctn.com/pdf/25824611

The effects of virtual reality exposure therapy (VRET) to ... The aim of this study is to find out whether VRET is an effective way of helping patients who suffer from dental anxiety. Who can participate?

6. researchgate.net researchgate.net/publication/317401693_Virtual_Reality_Exposure_Therapy_for_Treatment_of_Dental_Phobia

(PDF) Virtual reality exposure therapy for treatment of ... The primary outcome measures include participants' dental trait anxiety (Modified Dental Anxiety Scale and Dental Fear Survey) and state anxiety ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0300571225003495

Virtual reality for patients with dental anxiety: A scoping ... 31 studies found that VR glasses significantly reduced pain and anxiety during dental treatment. VR was useful for managing children's behavior during dental ...