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The Use of Virtual Reality Goggles

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ClinicalTrials.gov Identifier: NCT03486717
Recruitment Status : Completed
First Posted : April 3, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Casey Goetz, University of Iowa

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.

Condition or disease Intervention/treatment Phase
Dental Anxiety Device: Virtual reality goggles Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: The Use of Virtual Reality Goggles on Patient Pain and Behavior in Pediatric Dentistry; a Pilot Study
Actual Study Start Date : May 1, 2018
Actual Primary Completion Date : December 20, 2018
Actual Study Completion Date : December 21, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Control
Study group that does not wear the virtual reality goggles. This group will serve as a control.
Device: 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.




Primary Outcome Measures :
  1. Self-reported patient perception of pain [ Time Frame: 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.

  2. Behavior of child [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • History of dental anxiety

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03486717


Locations
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United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52241
Sponsors and Collaborators
Casey Goetz
Investigators
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Principal Investigator: Casey Goetz, DDS University of Iowa

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Responsible Party: Casey Goetz, Pediatric Dentistry Resident, University of Iowa
ClinicalTrials.gov Identifier: NCT03486717     History of Changes
Other Study ID Numbers: 201803829
First Posted: April 3, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No