Virtual Reality in Pediatric Dentistry (NCT05585905) | Clinical Trial Compass
CompletedNot Applicable
Virtual Reality in Pediatric Dentistry
United States20 participantsStarted 2023-03-17
Plain-language summary
Dental Fear and Anxiety is an emotional experiences affecting many children and adolescents which can lead to behavioral problems in the dental setting. The purpose of the proposed study is to investigate the effect of virtual reality on anxiety, behavior, and pain in children undergoing restorative dental procedures. Children enrolled in the study will include patients ages 6-18 who are healthy and require two or more dental sealants (at least one sealant per side). The participants in the study will serve as their own control using a split-mouth cross-over randomized control clinical trial design and will be randomly assigned to receive virtual reality or traditional behavior guidance techniques first during dental sealant placement. The objectives of this study are to explore the associations between the use of virtual reality distraction during dental sealant placement with anxiety based on the change in heart rate, compared with to the control group. This model will include treatment, visit, treatment by visit interaction term as well as a treatment sequence variable. This is a pilot study. Data analyzed will be changed in heart rate between baseline and sealant placement using virtual reality or behavior guidance technique.. No statistical analysis will be conducted except mean and range.
Who can participate
Age range
6 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 6-18
* ASA I or II
* Present to the Herman Ostrow School of Dentistry Pediatric Dental Clinic and Children's Dental Health Clinic at Long Beach Memorial Hospital for an initial or periodic exam, and are determined to require two or more dental sealants (at least one sealant per half mouth)
Exclusion Criteria:
Children with visual, auditory, or tactile deficits that would interfere with the ability to complete the experimental tasks
* Children who are unable to tolerate the RelievRx by AppliedVR will be screened after consenting to research participation by trying on the VR goggles and stating that they are comfortable and willing to proceed with wearing them during their dental appointment.
* Examples of children who may be unable to tolerate the VR goggles may include:
* Children who wear glasses and are unable to comfortably adjust the system over their glasses
* Children who experience dizziness, motion sickness or other discomfort during use
* Children who remove the VR goggles prior to dental sealant application
* Children who require pharmacological means to complete dental treatment (nitrous oxide, sedative drugs or general anesthesia)
* Children with a significant medical history of seizure disorders as flickering from devices can trigger epileptic episodes.
* Children with developmental disabilities
* Children with a psychiatric disorder, organic brain syndrome, mental retardation, or other known cognitive/neurological disorders
* C…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Beats Per Minute Change With VR
Timeframe: Time from is from baseline until sealant placement with VR
2
Beats Per Minute Change With BBG
Timeframe: Time from is from baseline until sealant placement with BBG