Pain Clinical Trial
Official title:
Use of Virtual Reality Glasses as an Audiovisual Distraction Technique During Anesthesia in Behavior, Anxiety and Pain Perception in Children
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.
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.
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