Virtual Reality Exposure for Dental Fear

NCT06494176 | Active Not Recruiting

• 1 other identifier: s23-00772
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Fear

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (2)

VRET Intervention

EXPERIMENTAL

Behavioral: neVR Fear the Dentist

Active Control

NO INTERVENTION

Interventions

neVR Fear the Dentist BEHAVIORAL

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).

VRET Intervention

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• New York University: lead
• Virtually Better, Inc.: collaborator

Study Sites (1)

New York University

New York, New York, 10010, United States

Location

Study Officials

• Richard Heyman, PhD

  New York University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: July 10, 2024
• Study Start: August 9, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 11, 2026

Record last verified: 2025-05

Locations

US (1)