Virtual Reality in Pediatric Dentistry

NCT05585905 | Completed FDA Device

• 1 other identifier: UP-21-00583
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Behavior, Child; Anxiety, Dental

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Change in behavior on the FLACCS scale

  Behavior Rating Score (FLACCS): Patient's behavior as rated by the FLACC behavioral pain scale. FLACC score includes facial expressions, leg movement, activity (bodily movement), crying, and consolability. Each category is score on the 0-2 scale resulting in a in a total score of 0-10. * 0 = Relaxed and comfortable * 1-3 = Mild discomfort * 4-6 = Moderate pain 12 * 7-10 = Severe discomfort/pain

  Baseline, Immediately after sealant placement with Virtual Reality, Immediately after sealant placement with basic behavior guidance techniques

• Change in behavior on the FRANKL Scale

  Patient's behavior as rated by the dental provider within one of the following categories: 1= definitely negative, 2= negative, 3= positive, 4= definitely positive. This scale is routinely used by dentists and documented in the patient chart.

  Baseline, IImmediately after sealant placement with Virtual Reality, Immediately after sealant placement with basic behavior guidance techniques, and immediately after completion of dental treatment

• Change in anxiety

  Measured by change in heart rate (eg. beats per minute)

  Baseline, Immediately after sealant placement with Virtual Reality, Immediately after sealant placement with basic behavior guidance techniques, and immediately after completion of dental treatment

• Patient perceived pain

  Patient's pain will be evaluated using the self-assessment Face Pain Scale- Revised (FPS-R) taken at outlined points (above) during restorative procedure. The FPS-R has 0-to-10 metric. The scale shows a close linear relationship with visual analog pain scales. Score the chosen face 0, 2, 4, 6, 8, or 10, counting left to right, so "0" equals "No pain" and "10" equals "Very much pain."

  Immediately after sealant placement with Virtual Reality, Immediately after sealant placement with basic behavior guidance techniques

Secondary Outcomes (2)

• Parent Satisfaction

  5 minutes after the completion of treatment

• Patient Satisfaction

  5 minutes after the completion of treatment

Study Arms (2)

Virtual Reality

EXPERIMENTAL

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

Basic Behavior Guidance Techniques

ACTIVE COMPARATOR

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

Interventions

Virtual Reality DEVICE

The VR system will be worn for approximately 5-10 minutes during dental sealant application

Virtual Reality

Basic Behavior Guidance Techniques BEHAVIORAL

Basic behavior guidance techniques will be used as a distraction technique when the VR system is not used during the dental sealant application

Basic Behavior Guidance Techniques

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (2)

Children's Dental Health Clinic

Long Beach, California, 90806, United States

Location

Herman Ostrow School of Dentistry Pediatric Department

Los Angeles, California, 90089, United States

Location

Related Publications (19)

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  PMID: 28377646 BACKGROUND

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• Ramos-Jorge ML, Marques LS, Pavia SM, Serra-Negra JM, Pordeus IA. Predictive factors for child behaviour in the dental environment. Eur Arch Paediatr Dent. 2006 Dec;7(4):253-7. doi: 10.1007/BF03262561.

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• Porritt J, Marshman Z, Rodd HD. Understanding children's dental anxiety and psychological approaches to its reduction. Int J Paediatr Dent. 2012 Nov;22(6):397-405. doi: 10.1111/j.1365-263X.2011.01208.x. Epub 2012 Jan 3.

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• American Academy of Pediatric Dentistry. Behavior guidance for the pediatric dental patient. The Reference Manual of Pediatric Dentistry. Chicago, Ill.: American Academy of Pediatric Dentistry; 2021:306-24.

  BACKGROUND

• Aminabadi NA, Farahani RM, Balayi Gajan E. The efficacy of distraction and counterstimulation in the reduction of pain reaction to intraoral injection by pediatric patients. J Contemp Dent Pract. 2008 Sep 1;9(6):33-40.

  PMID: 18784857 BACKGROUND

• Khandelwal M, Shetty RM, Rath S. Effectiveness of Distraction Techniques in Managing Pediatric Dental Patients. Int J Clin Pediatr Dent. 2019 Jan-Feb;12(1):18-24. doi: 10.5005/jp-journals-10005-1582.

  PMID: 31496566 BACKGROUND

• Lopez-Valverde N, Muriel Fernandez J, Lopez-Valverde A, Valero Juan LF, Ramirez JM, Flores Fraile J, Herrero Payo J, Blanco Antona LA, Macedo de Sousa B, Bravo M. Use of Virtual Reality for the Management of Anxiety and Pain in Dental Treatments: Systematic Review and Meta-Analysis. J Clin Med. 2020 Apr 5;9(4):1025. doi: 10.3390/jcm9041025.

  PMID: 32260538 BACKGROUND

• Piskorz J, Czub M. Effectiveness of a virtual reality intervention to minimize pediatric stress and pain intensity during venipuncture. J Spec Pediatr Nurs. 2018 Jan;23(1). doi: 10.1111/jspn.12201. Epub 2017 Nov 20.

  PMID: 29155488 BACKGROUND

• Walther-Larsen S, Petersen T, Friis SM, Aagaard G, Drivenes B, Opstrup P. Immersive Virtual Reality for Pediatric Procedural Pain: A Randomized Clinical Trial. Hosp Pediatr. 2019 Jul;9(7):501-507. doi: 10.1542/hpeds.2018-0249. Epub 2019 Jun 3.

  PMID: 31160472 BACKGROUND

• Li A, Montano Z, Chen VJ, Gold JI. Virtual reality and pain management: current trends and future directions. Pain Manag. 2011 Mar;1(2):147-157. doi: 10.2217/pmt.10.15.

  PMID: 21779307 BACKGROUND

• Carl E, Stein AT, Levihn-Coon A, Pogue JR, Rothbaum B, Emmelkamp P, Asmundson GJG, Carlbring P, Powers MB. Virtual reality exposure therapy for anxiety and related disorders: A meta-analysis of randomized controlled trials. J Anxiety Disord. 2019 Jan;61:27-36. doi: 10.1016/j.janxdis.2018.08.003. Epub 2018 Aug 10.

  PMID: 30287083 BACKGROUND

• Lahti S, Suominen A, Freeman R, Lahteenoja T, Humphris G. Virtual Reality Relaxation to Decrease Dental Anxiety: Immediate Effect Randomized Clinical Trial. JDR Clin Trans Res. 2020 Oct;5(4):312-318. doi: 10.1177/2380084420901679. Epub 2020 Jan 21.

  PMID: 31962052 BACKGROUND

• Tanja-Dijkstra K, Pahl S, White MP, Andrade J, May J, Stone RJ, Bruce M, Mills I, Auvray M, Gabe R, Moles DR. Can virtual nature improve patient experiences and memories of dental treatment? A study protocol for a randomized controlled trial. Trials. 2014 Mar 22;15:90. doi: 10.1186/1745-6215-15-90.

  PMID: 24655569 BACKGROUND

• Hosey MT, Blinkhorn AS. An evaluation of four methods of assessing the behaviour of anxious child dental patients. Int J Paediatr Dent. 1995 Jun;5(2):87-95. doi: 10.1111/j.1365-263x.1995.tb00170.x.

  PMID: 7547819 BACKGROUND

• American Academy of Pediatric Dentistry. Use of nitrous oxide for pediatric dental patients. The Reference Manual of Pediatric Dentistry. Chicago, Ill.: American Academy of Pediatric Dentistry; 2020:324-9.

  BACKGROUND

• Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.

  PMID: 9220806 BACKGROUND

• Hockenberry MJ, Wilson D, Winkelstein ML: Wong's Essentials of Pediatric Nursing, ed, 7, St Louis, 2005 p.1259. Used with permission. © Mosby

  BACKGROUND

MeSH Terms

Conditions

Child Behavior; Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Behavior; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Carla Angela Alvarez, DMD

  Herman Ostrow School of Dentistry Pediatric Department

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 19, 2022
• Study Start: March 17, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: November 5, 2025

Record last verified: 2025-11

Locations

US (2)