Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Use of Virtual Reality Glasses During Anesthesia in Behavior, Anxiety and Pain Perception of Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03902158
Recruitment Status : Recruiting
First Posted : April 3, 2019
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Maximiliano Sergio Cenci, Federal University of Pelotas

Brief Summary:

One of the most challenging aspects of Pediatric Dentistry is the management of child behavior. Among the procedures performed, local anesthesia is one of the factors that influence the increase in fear and anxiety in children in relation to dental procedures. This study aims to evaluate the effect of the use of virtual reality glasses as an audiovisual distraction technique during anesthesia in behavior, anxiety and pain perception, comparing it with traditional behavior management techniques. A sample of 44 children was estimated and will be selected with the following inclusion criteria: be between 5 and 9 years of age; good general health; no prior dental experience involving anesthesia in the last 2 years; need for restorative treatment or exodontia under local anesthesia. Children with physical or mental disabilities will be excluded and those who report poor behavior in dental consultations will be excluded. The sample will be randomized with 22 envelopes for the group that will use the glasses during the procedure(G0) and 22 envelopes containing group that will not use the glasses in consultation (G1).

The treatments will be performed in 2 visits, the first for initial examination, and the other for performing the procedures are either extraction or restorative treatment with the use of local anesthesia. During dental treatment, the dentist will explain the procedure in layman's terms using the basic techniques of behavior management, such as the "tell-show-do" technique, positive reinforcement, conventional distraction in all consultations. When using the distraction technique with virtual reality during the procedure, the virtual stereo glasses model HDMI-MHL 98 Inches (98') will be used. In all two consultations, VENHAM anxiety will be assessed through VENHAM scale and heart rate measurement at the beginning, during and at the end of the visit, as well as the perception of pain during the procedure (FLACC) and after finishing the service through the FPS-R scale. During the visits, the data will be collected using a previously tested tab. The data will be entered into a worksheet in the Microsoft® Excel® 2016 program and analyzed in the Stata 14.0 program. There will be a single blind blinding: both for the typist and who will analyze the data. A descriptive analysis of the data will be performed, obtaining the absolute and relative frequencies. Comparisons in the outcomes of interest between groups G0 and G1 will be performed using the chi-square test for dichotomous variables and the t-test for comparison of means. A significance level of 5% will be adopted for all analyzes.


Condition or disease Intervention/treatment Phase
Pain Device: Glasses Behavioral: Distraction techniques Not Applicable

Detailed Description:

One of the most challenging aspects of Pediatric Dentistry is the management of child behavior. Anxiety is often manifested by children during dental appointments, and may represent a challenge in the dental surgeon's clinical practice. Among the procedures performed, local anesthesia is one of the factors that influence the increase in fear and anxiety in children in relation to dental procedures. In view of the basic techniques used to manage children's behavior, distraction has been widely used to provide a more relaxed and effective experience during dental treatment for children. Thus, this study aims to evaluate the effect of the use of virtual reality glasses as an audiovisual distraction technique during anesthesia in behavior, anxiety and pain perception, comparing it with traditional behavior management techniques. A sample of 44 children was estimated and will be selected with the following inclusion criteria: be between 5 and 9 years of age; good general health; no prior dental experience involving anesthesia in the last 2 years; need for restorative treatment or exodontia under local anesthesia. Children with physical or mental disabilities will be excluded and those who report poor behavior in dental consultations will be excluded. The sample will be randomized through the draw of envelopes at the time of the service, being 22 envelopes for the group that will use the glasses during the procedure(G0) and 22 envelopes containing group that will not use the glasses in consultation (G1).

The treatments will be performed in 2 visits, the first for initial examination, and the other for performing the procedures are either extraction or restorative treatment with the use of local anesthesia. During dental treatment, the dentist will explain the procedure in layman's terms using the basic techniques of behavior management, such as the "tell-show-do" technique, positive reinforcement, conventional distraction in all consultations. When using the distraction technique with virtual reality during the procedure, the virtual stereo glasses model HDMI-MHL 98 Inches (98) will be used. In all two consultations, VENHAM anxiety will be assessed through VENHAM scale and heart rate measurement at the beginning, during and at the end of the visit, as well as the perception of pain during the procedure (FLACC) and after finishing the service through the FPS-R scale. During the visits, the data will be collected using a previously tested tab. The data will be entered into a worksheet in the Microsoft® Excel® 2016 program and analyzed in the Stata 14.0 program. There will be a single blind blinding: both for the typist and who will analyze the data. A descriptive analysis of the data will be performed, obtaining the absolute and relative frequencies. Comparisons in the outcomes of interest between groups G0 and G1 will be performed using the chi-square test for dichotomous variables and the t-test for comparison of means. A significance level of 5% will be adopted for all analyzes.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Use of Virtual Reality Glasses as an Audiovisual Distraction Technique During Anesthesia in Behavior, Anxiety and Pain Perception in Children
Estimated Study Start Date : April 15, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Eye Wear

Arm Intervention/treatment
Experimental: Glasses Device: Glasses
The patient will wear virtual reality glasses during anesthesia

Behavioral: Distraction techniques
The patient will undergo distraction techniques

No Intervention: Distraction techniques
No glasses will be used



Primary Outcome Measures :
  1. Perception of pain [ Time Frame: 5 minutes after anesthesia, i.e., after anesthesia, VAS will be performed in a maximum of 5 minutes after anesthesia ]
    Visual analogue scale (VAS) will be used to measure pain immediately after treatment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   5 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • good general health;
  • no prior dental experience involving anesthesia in the last 2 years;
  • need for restorative treatment or exodontia under local anesthesia.

Exclusion Criteria:

  • physical or mental disabilities;
  • report of poor behavior during dental treatment.

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): NCT03902158


Locations
Layout table for location information
Brazil
School of Dentistry Recruiting
Pelotas, RS, Brazil, 96015080
Contact: Marília L Goettems, PhD    555332606741    mariliagoettems@hotmail.com   
Sponsors and Collaborators
Federal University of Pelotas
Layout table for additonal information
Responsible Party: Maximiliano Sergio Cenci, Clinical Professor, Federal University of Pelotas
ClinicalTrials.gov Identifier: NCT03902158    
Other Study ID Numbers: PPGO 0028
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No