Clinical trial NCT06494176: Virtual Reality Exposure for Dental Fear
Official title: Disseminable Evidence-Based Treatment for the Dental Office: Virtual Exposure Tools for Dental Fear - neVR Fear the Dentist
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Fear
Lead sponsor: New York University
Sponsor class: OTHER
Collaborators: name: Virtually Better, Inc.
First posted: 2024-07-10
Enrollment: 250
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 an/or assent form (if applicable)
5. Proficient in English because the intervention is in English
6. Have access to a smartphone or tablet
7. Attending dental appointments at one of our participating dental practices.

Exclusion Criteria:

1. Hearing or visual impairment such as stereoscopy blindness or nystagmus
2. Known mental disorders such as psychosis, post-traumatic stress disorder (PTSD), developmental or intellectual disability, cognitive impairment
3. Known balance disorders such as vertigo and cybersickness
4. Previous history of epileptic seizures
5. A history of cardiac problems
6. Are in pain, require urgent care, or whose necessary treatment will be delayed by participating in the study

Primary outcomes:
measure: Reduction in dental fear
timeFrame: Measure will be collected at baseline, immediately post-treatment, and 1-, 3-, and 6-months post treatment.
measure: Dental fear and anxiety
timeFrame: Measure will be collected at baseline, immediately post-treatment, and 1-, 3-, and 6-months post treatment.
measure: Anticipatory dental fear
timeFrame: Measure will be collected at baseline, immediately post-treatment, and 1-, 3-, and 6-months post treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University
state: New York
Study officials:
affiliation: New York University
name: Richard Heyman, PhD
role: PRINCIPAL_INVESTIGATOR
References: