An interventional study of Virtual Reality and Basic Behavior Guidance Techniques in Behavior, Child and Anxiety, Dental, sponsored by University of Southern California. Completed at 2 sites in United States. Open to participants aged 6 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by University of Southern California · Not applicable, Interventional, and Treatment
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.
This study is a randomized controlled trial with a crossover design. Patients who are visiting the clinic for a comprehensive or periodic dental exam and are found to require two or more dental sealants (at least one sealant per side). The study subjects will include children ages 6-18 who are ASA I or II, as defined by the American Society of Anesthesiologists classification system. The proposed sample size for the study is 40 participants.
The children who are enrolled in the study will serve as both the experimental group and their own control. This is a split mouth design in which children who are enrolled in the study will serve as both the experimental group and their own control. After the child and parent are scheduled for the dental sealant appointment, they will be randomly assigned to receive the virtual reality system as a distraction technique for the first half or the latter half of the appointment (for research purposes). During the time when virtual reality is not used, traditional basic behavior guidance techniques will be used, as is the standard of care.
The virtual reality system being used for research purposes is the RelieVR by Applied VR which includes the goggle headset only. The VR experience will be an immersive experience where the child will interact with the system and navigate their way through a game that will involve bright colors, cartoon-like characters and settings with age-appropriate content. The VR system will be worn for approximately 5-10 minutes during the dental sealant application.
The behavior, and anxiety will be analyzed at specific steps of the procedure including:
The patient's anxiety will be evaluated with a change in heart rate.
Additionally, at the end of each appointment for the duration of the study, the provider will assign the patient a Frankl behavior score 1-5, and record it in the patient's chart, as is the standard of care. The provider will also complete a Healthcare Provider Questionnaire through Qualtrics.
The demographic factors will be collected from the patient's medical chart. The parent will be asked "how many hours of "screen time" (TV, computer, video games, tablet use), would you say that your child is allowed per week?". Parents and patients will also be asked to complete a satisfaction survey post-treatment.
224 studies on the registry are indexed under Child Behavior; 41 are open to participants now.
This study's enrollment of 20 is below the median of 140 across 197 interventional studies indexed under Child Behavior.
Browse Child Behavior studies →University of Southern California is the lead sponsor of 791 studies on the registry; 136 are open to participants now.
Of its 70 completed or terminated interventional studies of FDA-regulated products, 32 (46%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Children with visual, auditory, or tactile deficits that would interfere with the ability to complete the experimental tasks
Examples of children who may be unable to tolerate the VR goggles may include:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The virtual reality system being used for research purposes is the RelievRx by AppliedVR which is an immersive virtual reality device that includes a goggle headset and remote control. The VR experience will be an immersive experience where the child will interact with the system and navigate their way through a game that will involve bright colors, cartoon-like characters, and settings with age-appropriate content.
Device: Virtual Reality
The control sample will include basic behavior guidance techniques and is standard of care. The use of basic behavior guidance techniques is common in pediatric dentistry and is not unique to this study.
Behavioral: Basic Behavior Guidance Techniques
The VR system will be worn for approximately 5-10 minutes during dental sealant application
Basic behavior guidance techniques will be used as a distraction technique when the VR system is not used during the dental sealant application
Beats Per Minute Change With VR
Behavior and anxiety measured by changed in heart rate were scored at baseline and during sealant placement with virtual reality
Time frame: Time from is from baseline until sealant placement with VR
Beats Per Minute Change With BBG
Behavior and anxiety measured by changed in heart rate were scored at baseline and during sealant placement with basic behavior guidance.
Time frame: Time from is from baseline until sealant placement with BBG
Patients were offered enrollment when treatment planned for sealants
| Milestone | Virtual Reality (VR) With Right Side Seals First, Then Basic Behavior Guidance (BBG) With Left Side | VR With Left Side Seals First, Then BBG With Seals on Right Side | BBG With Right Side Sealants First, Then VR With Left Side Sealant | BBG With Left Side Sealants First, Then VR With Right Side Sealant |
|---|---|---|---|---|
| Started | 4 | 4 | 8 | 4 |
| Completed | 4 | 4 | 7 | 4 |
| Not completed | 0 | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 | 0 |
Behavior and anxiety measured by changed in heart rate were scored at baseline and during sealant placement with virtual reality
| Beats per minute | Virtual Reality (VR) With Right Side Seals First, Then Basic Behavior Guidance (BBG) With Left Side | VR With Left Side Seals First, Then BBG With Seals on Right Side | BBG With Right Side Sealants First, Then VR With Left Side Sealant | BBG With Left Side Sealants First, Then VR With Right Side Sealant |
|---|---|---|---|---|
| Beats Per Minute Change With VR | -2 (-9 to 2) | -6.25 (-9 to -4) | -8.8 (-18 to 4) | -6.25 (-12 to -3) |
Behavior and anxiety measured by changed in heart rate were scored at baseline and during sealant placement with basic behavior guidance.
| Beats per minute | Virtual Reality (VR) With Right Side Seals First, Then Basic Behavior Guidance (BBG) With Left Side | VR With Left Side Seals First, Then BBG With Seals on Right Side | BBG With Right Side Sealants First, Then VR With Left Side Sealant | BBG With Left Side Sealants First, Then VR With Right Side Sealant |
|---|---|---|---|---|
| Beats Per Minute Change With BBG | -2 (-13 to 8) | -2.75 (-10 to 1) | -3 (-14 to 15) | -0.5 (-16 to 7) |
Collected over No SAEs or AEs were collected or monitored. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Virtual Reality (VR) With Right Side Seals First, Then Basic Behavior Guidance (BBG) With Left Side | — | — | — |
| VR With Left Side Seals First, Then BBG With Seals on Right Side | — | — | — |
| BBG With Right Side Sealants First, Then VR With Left Side Sealant | — | — | — |
| BBG With Left Side Sealants First, Then VR With Right Side Sealant | — | — | — |
The numbers listed are the number of participants in each group which were randomly selected. The study was a pilot study.
| Age, Categorical(Participants) | Virtual Reality (VR) With Right Side Seals First, Then Basic Behavior Guidance (BBG) With Left Side | VR With Left Side Seals First, Then BBG With Seals on Right Side | BBG With Right Side Sealants First, Then VR With Left Side Sealant | BBG With Left Side Sealants First, Then VR With Right Side Sealant | Total |
|---|---|---|---|---|---|
| <=18 years | 4 | 4 | 8 | 4 | 20 |
| Between 18 and 65 years | 0 | 0 | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Virtual Reality (VR) With Right Side Seals First, Then Basic Behavior Guidance (BBG) With Left Side | VR With Left Side Seals First, Then BBG With Seals on Right Side | BBG With Right Side Sealants First, Then VR With Left Side Sealant | BBG With Left Side Sealants First, Then VR With Right Side Sealant | Total |
|---|---|---|---|---|---|
| Female | 3 | 2 | 4 | 4 | 13 |
| Male | 1 | 2 | 4 | 0 | 7 |
| Race and Ethnicity Not Collected(Participants) | Virtual Reality (VR) With Right Side Seals First, Then Basic Behavior Guidance (BBG) With Left Side | VR With Left Side Seals First, Then BBG With Seals on Right Side | BBG With Right Side Sealants First, Then VR With Left Side Sealant | BBG With Left Side Sealants First, Then VR With Right Side Sealant | Total |
|---|---|---|---|---|---|
| Count of participants | — | — | — | — | 0 |
| Heart Rate Baseline(beats per minute) | Virtual Reality (VR) With Right Side Seals First, Then Basic Behavior Guidance (BBG) With Left Side | VR With Left Side Seals First, Then BBG With Seals on Right Side | BBG With Right Side Sealants First, Then VR With Left Side Sealant | BBG With Left Side Sealants First, Then VR With Right Side Sealant | Total |
|---|---|---|---|---|---|
| Mean | 87.7 (64 to 106) | 75.25 (63 to 92) | 76.6 (61 to 90) | 90.75 (80 to 108) | 82.575 (61 to 108) |
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