Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-25 @ 3:31 AM
NCT ID:
NCT05585905
Eligibility Criteria:
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
* Children that are not English or Spanish speaking
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
18 Years
Study:
NCT05585905
Study Brief:
Protocol Section:
NCT05585905