The Use of Virtual Reality Goggles

NCT ID: NCT03486717

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2018-12-21

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.

Conditions

Dental Anxiety

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Control

Study group that does not wear the virtual reality goggles. This group will serve as a control.

Group Type: EXPERIMENTAL

Virtual reality goggles

Intervention Type: DEVICE

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.

Interventions

Virtual reality goggles

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• History of dental anxiety

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Casey Goetz

OTHER

Sponsor Role: lead

Responsible Party

Casey Goetz

Pediatric Dentistry Resident

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Casey Goetz, DDS

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa

Iowa City, Iowa, United States

Countries

United States

Other Identifiers

201803829

Identifier Type: -

Identifier Source: org_study_id