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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

Tracking Information
First Submitted Date  ICMJE March 27, 2018
First Posted Date  ICMJE April 3, 2018
Last Update Posted Date February 15, 2019
Actual Study Start Date  ICMJE May 1, 2018
Actual Primary Completion Date December 20, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 8, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 27, 2018)
  • Pain [ Time Frame: immediately after treatment ]
    self reported pain scale by patient
  • Behavior [ Time Frame: immediately after treatment ]
    behavior reported by an unbiased dental assistant
Change History Complete list of historical versions of study NCT03486717 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Use of Virtual Reality Goggles
Official Title  ICMJE The Use of Virtual Reality Goggles on Patient Pain and Behavior in Pediatric Dentistry; a Pilot Study
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE Dental Anxiety
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Control
Study group that does not wear the virtual reality goggles. This group will serve as a control.
Intervention: Device: Virtual reality goggles
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2019)
7
Original Estimated Enrollment  ICMJE
 (submitted: March 27, 2018)
20
Actual Study Completion Date  ICMJE December 21, 2018
Actual Primary Completion Date December 20, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • History of dental anxiety
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03486717
Other Study ID Numbers  ICMJE 201803829
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Casey Goetz, University of Iowa
Study Sponsor  ICMJE Casey Goetz
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Casey Goetz, DDS University of Iowa
PRS Account University of Iowa
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP