Virtual Reality in Pediatric Dentistry

Sponsor

University of Southern California (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05585905

Collaborator

(none)

Enrollment

Locations

Arms

19.9

Anticipated Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Dental Fear and Anxiety is an emotional experience affecting many children and adolescents and 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 and behavior in children undergoing restorative dental procedures. Children enrolled in the study will include patients ages 6-18 who are healthy and require 2 or more appointments for restorative dental treatment. Each child will serve as their own control, and their behavior and anxiety will be measured at one appointment using traditional behavior management techniques with or without the use of nitrous oxide, and at another appointment while wearing a virtual reality headset as a distraction tool. The study outcomes including the child's Frankl Score, Face, Legs, Activity, Cry, Consolability scale (FLACC), Face Pain Scale- Revised (FPS-R), diastolic and systolic blood pressure, heart rate, and parent/patient satisfaction survey will be analyzed using t-tests.

Condition or Disease	Intervention/Treatment	Phase
Behavior, Child Anxiety, Dental	Device: Virtual Reality Behavioral: Nitrous Oxide-Oxygen	N/A

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 future appointments for restorative treatment will be recruited for the study. Restorative treatment will be defined as the placement of sealants, Class I, II or III composites, stainless steel crowns, and extractions needing local anesthesia administration. 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 38 participants.

The 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 their two necessary restorative dental appointments (standard of care), they will be randomly assigned to receive the virtual reality system as a distraction technique for one appointment (for research purposes). During the appointment where virtual reality is not used, traditional basic behavior guidance techniques with/without nitrous oxide will be used, as is the standard of care.

The virtual reality system being used for research purposes is RelievRx by AppliedVR which includes a goggle headset and handheld remote. The VR system will be worn for approximately 5-10 minutes during the administration of local anesthesia. Each patient will serve as their own control.

Each of the restorative dental appointments will be video recorded, for research purposes and data collection. The video camera will be placed to include the child's face in order to monitor their facial expressions, legs movement, and activity during the administration of local anesthesia. The video camera will also be placed to include the blood pressure monitor and heart rate readings.

The behavior, pain, and anxiety will be analyzed at specific steps of the procedure including:

Baseline (patient sitting in the chair prior to treatment)
Local anesthetic injection
Post Operative (patient sitting upright in chair)

The Face, Legs, Activity, Cry, Consolabilit (FLACC) scale is a behavioral pain scale that will be conducted at the previously mentioned time intervals.

Patient's anxiety will be evaluated with systolic and diastolic blood pressure and 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.

Data will be analyzed statistically to assess the relationship between a child's behavior (measured by the Frankl score and FLACCS scale), pain (measured by FPS-R) and anxiety (measured by heart rate and blood pressure) with the use of virtual reality or nitrous oxide as a behavior management technique. Other factors will also be analyzed including timing of intervention (1st vs. 2nd appointment), age, gender, type of local anesthetic administration (maxillary infiltration or inferior alveolar nerve block (IAN), previous dental experience, and average amount of "screen time" a child is allowed per week.

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 will also be asked to complete a satisfaction survey after the Virtual Reality appointment and the Standard of Care appointment.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Effect of Virtual Reality on the Behavior of Pediatric Dental Patients During Local Anesthesia Administration

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

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.	Device: Virtual Reality The VR system will be worn for approximately 5-10 minutes during the administration of local anesthesia.
Active Comparator: Nitrous Oxide-Oxygen The control sample will include basic behavior guidance techniques with/without nitrous oxide. The American Academy of Pediatric Dentistry (AAPD) recognizes nitrous oxide/oxygen inhalation as a safe and effective technique that is routinely used during dental care to reduce anxiety and produce analgesia. The techniques for the use of nitrous oxide are standard when providing dental treatment to anxious patients. Nitrous oxide use is common in pediatric dentistry and is not unique to this study.	Behavioral: Nitrous Oxide-Oxygen The patient will settle on 50% nitrous oxide/oxygen mixture for 5-10 minutes before the administration of local anesthesia. The patient will receive the nitrous oxide/oxygen mixture until the restorative treatment is completed.

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.

Device: Virtual Reality

The VR system will be worn for approximately 5-10 minutes during the administration of local anesthesia.

Active Comparator: Nitrous Oxide-Oxygen

The control sample will include basic behavior guidance techniques with/without nitrous oxide. The American Academy of Pediatric Dentistry (AAPD) recognizes nitrous oxide/oxygen inhalation as a safe and effective technique that is routinely used during dental care to reduce anxiety and produce analgesia. The techniques for the use of nitrous oxide are standard when providing dental treatment to anxious patients. Nitrous oxide use is common in pediatric dentistry and is not unique to this study.

Behavioral: Nitrous Oxide-Oxygen

The patient will settle on 50% nitrous oxide/oxygen mixture for 5-10 minutes before the administration of local anesthesia. The patient will receive the nitrous oxide/oxygen mixture until the restorative treatment is completed.

Outcome Measures

Primary Outcome Measures

Change in behavior on the FLACCS scale [Baseline, Immediately after local anesthetic injection, and immediately after completion of dental treatment]
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
Change in behavior on the FRANKL Scale [Baseline, Immediately after local anesthetic injection, and immediately after completion of dental treatment]
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.
Change in anxiety [Baseline, Immediately after local anesthetic injection, and immediately after completion of dental treatment]
Measured by change in heart rate (eg. beats per minute) and blood pressure (diastolic and systolic pressure) during restorative procedure.
Patient perceived pain [Immediately after local anesthetic injection]
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."

Secondary Outcome Measures

Parent Satisfaction [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.
Patient Satisfaction [Immediately after local anesthetic injection and 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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 initial or periodic exam, and are determined to require two or more restorative appointments

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 administration of local anesthesia
Children who require pharmacological means to complete dental treatment (sedative drugs or general anesthesia)
Children who have contraindications to nitrous oxide such as chronic obstructive pulmonary disease, current upper respiratory tract infections, recent middle ear disturbances or surgeries, severe emotional disturbances, drug related dependencies, and methylenetetrahydrofolate reductase deficiency17
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Dental Health Clinic	Long Beach	California	United States	90806
2	Herman Ostrow School of Dentistry Pediatric Department	Los Angeles	California	United States	90089