The Use of Virtual Reality Goggles

Study Overview
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Brief Summary
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The purpose of this research study is to evaluate the effectiveness of virtual-reality audio-visual distraction goggles on pain and behavior scores in a population of 8-12 year old dental patients receiving routine dental care in an outpatient clinical setting.

Detailed Description
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All appointments will take place at the College of Dentistry Department of Pediatric Dentistry. The first day's appointment will consist of clinically-indicated cleaning, radiographs and treatment planning. Toward the end of the first appointment, the participant will wear the virtual reality goggles for 5 minutes, in order to become familiar with the device. During these 5 minutes, fluoride varnish will be applied. The application of the varnish would occur whether the participant is in the research or not. At the second or third appointments, the goggles will be randomly used during the restorative treatment. Whether the participant uses the goggles at the second or third visit will be determined purely by chance, like flipping a coin. No nitrous oxide will be used, but local anesthesia will still be administered as standard. The participant will use a 1-10 scale at the end of each appointment to rate pain levels, and a research team member(the dental assistant) will assign a 1-4 scale value for behavior. The 1-10 scale will consist of the Wong-Baker Faces Pain Scale.

Official Title
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The Use of Virtual Reality Goggles on Patient Pain and Behavior in Pediatric Dentistry; a Pilot Study

Conditions
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Dental Anxiety

Intervention / Treatment
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* Device: Virtual reality goggles


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, no history of seizures or neurological disturbance, requires two quadrants of dentistry Exclusion Criteria: History of dental anxiety

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control<br>Study group that does not wear the virtual reality goggles. This group will serve as a control. | Device: Virtual reality goggles<br>* Patients will act as their own control over two different dental appointments. One appointment will consist of wearing the virtual reality googles, the other appointment will be conducted without them. The goggles have a small screen inside of them along with headphones. This device will play an a movie or cartoon that will immerse the patient during treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported patient perception of pain | The patient will complete a self-reported pain scale known as the Wong-Baker Faces Pain Scale. This is a 1-10 pain scale that has correlating faces. A 1 indicates no pain, and correlates with a happy face. A 10 correlates with a crying face and indicates severe pain. A single number between 1-10 is selected to indicate the patient's pain. | recorded immediately after each treatment session, during both the control visit and the experimental visit (patient acts as their own control) | 
| Behavior of child | Behavior in terms of child cooperation will reported by an unbiased dental assistant using the Frankyl behavior scale. Behavior means the child listens to instructions and follows directions given by the clinician. This is a 1-4 scale, with 1 indicating extremely uncooperative behavior (crying, strong movement) and 4 indicating positive, cooperative behavior. | recorded immediately after each treatment session, during both the control visit and the experimental visit (patient acts as their own control) |