The Use of Virtual Reality Goggles

Not Applicable

Completed

• Conditions: Dental Anxiety
• Interventions: Device: Virtual reality goggles

• Registration Number: NCT03486717
• Lead Sponsor: Casey Goetz

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-03-27
• Study First Submitted QC: 2018-03-27
• Study First Posted: 2018-04-03
• Study Start: 2018-05-01
• Primary Completion: 2018-12-20
• Study Completion: 2018-12-21
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-12
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• Healthy, no history of seizures or neurological disturbance, requires two quadrants of dentistry

Exclusion Criteria

• History of dental anxiety

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control	Virtual reality goggles	Study group that does not wear the virtual reality goggles. This group will serve as a control.

Primary Outcome Measures

Name	Time	Method
Self-reported patient perception of pain	recorded immediately after each treatment session, during both the control visit and the experimental visit (patient acts as their own control)	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.
Behavior of child	recorded immediately after each treatment session, during both the control visit and the experimental visit (patient acts as their own control)	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.

Trial Locations

Locations (1)

University of Iowa; 🇺🇸 Iowa City, Iowa, United States