The Use of Virtual Reality Goggles

NCT03486717 | Completed FDA Device

• 1 other identifier: 201803829
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Anxiety

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (1)

Control

EXPERIMENTAL

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

Device: Virtual reality goggles

Interventions

Virtual reality goggles 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.

Control

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• History of dental anxiety

Sponsors & Collaborators

• Casey Goetz: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52241, United States

Location

Study Officials

• Casey Goetz, DDS

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Pediatric Dentistry Resident

Study Record Dates

• First Submitted: March 27, 2018
• First Posted: April 3, 2018
• Study Start: May 1, 2018
• Primary Completion: December 20, 2018
• Study Completion: December 21, 2018
• Last Updated: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)