- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05585905
Virtual Reality in Pediatric Dentistry
The Effect of Virtual Reality on the Behavior of Pediatric Dental Patients During Dental Sealant Application.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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:
- Baseline (patient sitting in the chair prior to treatment)
- During sealant placement with Virtual Reality distraction
- During sealant placement with basic behavior guidance techniques
- Post Operative (patient sitting upright in chair, 5 minutes after procedure)
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
California
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Long Beach, California, United States, 90806
- Children's Dental Health Clinic
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Los Angeles, California, United States, 90089
- Herman Ostrow School of Dentistry Pediatric Department
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual Reality
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.
|
The VR system will be worn for approximately 5-10 minutes during dental sealant application
|
|
Active Comparator: Basic Behavior Guidance Techniques
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.
|
Basic behavior guidance techniques will be used as a distraction technique when the VR system is not used during the dental sealant application
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Beats Per Minute Change With VR
Time Frame: Time from is from baseline until sealant placement with VR
|
Behavior and anxiety measured by changed in heart rate were scored at baseline and during sealant placement with virtual reality
|
Time from is from baseline until sealant placement with VR
|
|
Beats Per Minute Change With BBG
Time Frame: Time from is from baseline until sealant placement with BBG
|
Behavior and anxiety measured by changed in heart rate were scored at baseline and during sealant placement with basic behavior guidance.
|
Time from is from baseline until sealant placement with BBG
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parent Satisfaction
Time Frame: 5 minutes after the completion of treatment
|
Will be evaluated post treatment for the Virtual Reality and standard of care.
Satisfaction questions will be asked on a scale on a scale of 1 to 10.
|
5 minutes after the completion of treatment
|
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Patient Satisfaction
Time Frame: 5 minutes after the completion of treatment
|
Will be evaluated post treatment for the Virtual Reality and standard of care.
Satisfaction questions will be asked on a scale on a scale of 1 to 10.
|
5 minutes after the completion of treatment
|
Collaborators and Investigators
Investigators
- Study Chair: Carla Angela Alvarez, DMD, Herman Ostrow School of Dentistry Pediatric Department
Publications and helpful links
General Publications
- 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.
- Sharma A, Kumar D, Anand A, Mittal V, Singh A, Aggarwal N. Factors predicting Behavior Management Problems during Initial Dental Examination in Children Aged 2 to 8 Years. Int J Clin Pediatr Dent. 2017 Jan-Mar;10(1):5-9. doi: 10.5005/jp-journals-10005-1397. Epub 2017 Feb 27.
- Cianetti S, Lombardo G, Lupatelli E, Pagano S, Abraha I, Montedori A, Caruso S, Gatto R, De Giorgio S, Salvato R. Dental fear/anxiety among children and adolescents. A systematic review. Eur J Paediatr Dent. 2017 Jun;18(2):121-130. doi: 10.23804/ejpd.2017.18.02.07.
- 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.
- 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.
- Moore R, Brodsgaard I. Dentists' perceived stress and its relation to perceptions about anxious patients. Community Dent Oral Epidemiol. 2001 Feb;29(1):73-80.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Hockenberry MJ, Wilson D, Winkelstein ML: Wong's Essentials of Pediatric Nursing, ed, 7, St Louis, 2005 p.1259. Used with permission. © Mosby
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Mental Disorders
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Pain
- Anxiety Disorders
- Child Behavior
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, General
- Anesthetics
- Analgesics, Non-Narcotic
- Anesthetics, Inhalation
- Nitrous Oxide
Other Study ID Numbers
- UP-21-00583
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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