COMPLETED

Virtual Reality in Pediatric Dentistry

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 Frankl score, FLACC scale, and anxiety based on the change in heart rate, and pain based on self-reported FPS-R when compared with to the control group. The crossover design will be assessed by a linear mixed model with patient treated as a random effect. This model will include treatment, visit, treatment by visit interaction term as well as a treatment sequence variable. Prior to analysis, the primary outcome measures will be assessed for normality using a Shapiro-Wilk statistic as well as quantile-quantile (QQ) plots. Should the data deviate sharply from a normal distribution, normalizing transformations will be sought and applied to the data.

Official Title

The Effect of Virtual Reality on the Behavior of Pediatric Dental Patients During Dental Sealant Application.

Quick Facts

Study Start:2023-03-17
Study Completion:2024-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05585905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 6-18
  2. * ASA I or II
  3. * 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)
  1. * 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.
  2. * Examples of children who may be unable to tolerate the VR goggles may include:
  3. * Children who wear glasses and are unable to comfortably adjust the system over their glasses
  4. * Children who experience dizziness, motion sickness or other discomfort during use
  5. * Children who remove the VR goggles prior to dental sealant application
  6. * Children who require pharmacological means to complete dental treatment (nitrous oxide, sedative drugs or general anesthesia)
  7. * Children with a significant medical history of seizure disorders as flickering from devices can trigger epileptic episodes.
  8. * Children with developmental disabilities
  9. * Children with a psychiatric disorder, organic brain syndrome, mental retardation, or other known cognitive/neurological disorders
  10. * Children that are not English or Spanish speaking

Contacts and Locations

Principal Investigator

Carla Angela Alvarez, DMD
STUDY_CHAIR
Herman Ostrow School of Dentistry Pediatric Department

Study Locations (Sites)

Children's Dental Health Clinic
Long Beach, California, 90806
United States
Herman Ostrow School of Dentistry Pediatric Department
Los Angeles, California, 90089
United States

Collaborators and Investigators

Sponsor: University of Southern California

  • Carla Angela Alvarez, DMD, STUDY_CHAIR, Herman Ostrow School of Dentistry Pediatric Department

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

Study Start Date2023-03-17
Study Completion Date2024-06-30

Study Record Updates

Study Start Date2023-03-17
Study Completion Date2024-06-30

Terms related to this study

Keywords Provided by Researchers

  • Virtual Reality
  • Dental
  • Local Anesthesia
  • Nitrous Oxide
  • Anxiety
  • Pain

Additional Relevant MeSH Terms

  • Behavior, Child
  • Anxiety, Dental