Virtual Reality Exposure for Dental Fear

Disseminable Evidence-Based Treatment for the Dental Office: Virtual Exposure Tools for Dental Fear - neVR Fear the Dentist

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dental Fear
• Intervention / Treatment: Behavioral: neVR Fear the Dentist

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10010
      • New York University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Be at least 13 years of age
2. Report dental fear of 4 or higher on a scale of 0-10 on the Gatchel dental fear item
3. Be able and willing to comply with study procedures
4. Provide a signed and dated informed consent form
5. Proficient in English because the intervention is in English
6. Have access to a smartphone or tablet
7. If self-referred, have a dental appointment already scheduled with their own dentist.
8. If self-referred, live in the NYC metro area or are willing to travel to the NYU College of Dentistry.
9. If self-referred, have access to an Oculus headset and live in the U.S.

Exclusion Criteria:

1. Uncorrected, severe, or profound hearing or visual impairment such as stereoscopy blindness or nystagmus
2. Diagnosed with any of the following psychiatric conditions: Posttraumatic Stress Disorder (PTSD) due to dental trauma, Major Neurocognitive Disorder (Dementia), Schizophrenia, or Intellectual Disability
3. Current diagnosis of a balance disorder, such as vertigo
4. Lifetime history of cybersickness
5. Previous history of epileptic seizures
6. A history of cardiac problems
7. Are in pain, require urgent care, or whose necessary treatment will be delayed by participating in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VRET Intervention	Behavioral: neVR Fear the Dentist; neVR Fear the DentistTM comprises two major evidence-based interventions. First is a self-administered eHealth app for CBT/ psychoeducation with exposure therapy - delivered via a mobile tablet - that can be completed anywhere. Second is a 1-hr virtual reality exposure treatment (VRET).
No Intervention: Active Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in dental fear	Overall dental fear will be measured by the self-report Gatchel Dental Fear Item (Gatchel, 1987). This scale uses a one-item assessment of overall dental fear. Patients rate their dental fear on a scale of 0 = "None" to 10 = "High", with higher scores representing higher levels of fear.	Measure will be collected at baseline, immediately post-treatment, and 1-, 3-, and 6-months post treatment.
Dental fear and anxiety	Dental fear and anxiety will also be measured using the Index of Dental Fear and Anxiety (IDAF; Armfield, 2010), an 8-item patient-report survey. Responses range from 1 = "Disagree" to 5 = "Strongly Agree." Total scores range from 5 to 40 with higher scores representing more dental anxiety/fear.	Measure will be collected at baseline, immediately post-treatment, and 1-, 3-, and 6-months post treatment.
Anticipatory dental fear	Anticipatory dental fear will be measured via self-report using the Modified Dental Anxiety Scale (MDAS; Humphries et al., 1995), a 5-item scale. All items are rated on a 1-5 scale where 1 = "Not Anxious" and 5 = "Extremely Anxious," with total scores ranging from 5 to 25. Higher scores indicate higher dental anticipatory anxiety.	Measure will be collected at baseline, immediately post-treatment, and 1-, 3-, and 6-months post treatment.

Collaborators and Investigators

• Sponsor: New York University
• Collaborators: Virtually Better, Inc.
• Investigators: Principal Investigator: Richard Heyman, PhD, New York University

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: May 16, 2024
• First Submitted That Met QC Criteria: July 2, 2024
• First Posted (Actual): July 10, 2024

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: s23-00772

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No