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NCT Number: NCT06494176

Virtual Reality Exposure for Dental Fear

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Dental Fear

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University

New York, 10010, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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).

Primary outcomes

  1. Reduction in dental fear

    Time frame: Measure will be collected at baseline, immediately post-treatment, and 1-, 3-, and 6-months post treatment.

    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.

  2. Dental fear and anxiety

    Time frame: Measure will be collected at baseline, immediately post-treatment, and 1-, 3-, and 6-months post treatment.

    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.

  3. Anticipatory dental fear

    Time frame: Measure will be collected at baseline, immediately post-treatment, and 1-, 3-, and 6-months post treatment.

    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.

Sponsors and collaborators

Lead sponsor

New York University

Other

Collaborators

  • Virtually Better, Inc.

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 10, 2024
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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