NOT_YET_RECRUITING
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.
Conditions:
🦠 Dental Fear
🗓️ Study Start (Actual) August 2024
🗓️ Primary Completion (Estimated) December 2025
✅ Study Completion (Estimated) December 2026
👥 Enrollment (Estimated) 250
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 New York, New York, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Be at least 13 years of age
    • 2. Report dental fear of 4 or higher on a scale of 0-9 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

    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
Ages Eligible for Study: 13 Years to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 16 May 2024
  • First Submitted that Met QC Criteria 2 July 2024
  • First Posted 10 July 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 2 July 2024
  • Last Update Posted 10 July 2024
  • Last Verified May 2024