Clinical Trials Directory

Trials / Completed

CompletedNCT03428282

Pain and Anxiety Control During Traditional Mandibular Anesthesia in Children Using Distracting Tools

Effectiveness of Audio Visual Distraction Using Virtual Reality Eyeglasses Versus Tablet Device in Child Behavioral Management During Inferior Alveolar Nerve Block

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
102 (actual)
Sponsor
Damascus University · Academic / Other
Sex
All
Age
6 Years – 10 Years
Healthy volunteers
Not accepted

Summary

The aim of this study is to evaluate the effectiveness of two different audiovisual distraction techniques (Audio Video eyeglasses "VR BOX"/ Tablet) in the management of anxious pediatric patients during inferior alveolar nerve block Group A (Control group): IAN will be administrated with basic behavior guidance techniques and without using any type of distraction aids. Group B: IAN will be administrated with using AV eyeglasses "VR BOX" and wireless headphone. Group C: IAN will be administrated with using tablet device and wireless headphone All of the children who experienced an inferior alveolar block with/without distraction will be assessed by using a combination of measures: Wong-Baker FACES (self-report), pulse rate (physiological) and behavior (using FLACC behavior rating scale "external evaluator

Detailed description

This study will evaluate the effectiveness of two types of distraction aids that contain video using (tablet device or VR BOX eyeglasses) and audio distraction using wireless headphone. pain and anxiety will be evaluated during inferior alveolar nerve block using three behavioral scales, Wong-Baker FACES (self-report), pulse rate (physiological) and behavior (using FLACC behavior rating scale "external evaluator". The first measure of heart pulse rate will be recorded directly when the patient seated comfortably on the dental chair, after anesthesia, the second heart pulse rate will be taken and the child patients will ask to choose a face that describe their status from one of the Wong Baker faces scale. For each child patient, all of the body responses will be recorded during the whole procedure and then will be evaluated by an external assessor to determine the children behavioral score according to FLACC scale.

Conditions

Interventions

TypeNameDescription
PROCEDUREVR BoxDistraction will be made during the injection of the drug using this method.
PROCEDURETablet DeviceDistraction will be made during the injection of the drug using this method
DRUGAnesthesiaAnesthesia will be obtained by injecting the drug into the oral mucosa before performing the dental treatment.

Timeline

Start date
2017-05-15
Primary completion
2018-02-10
Completion
2018-07-15
First posted
2018-02-09
Last updated
2018-07-30

Locations

1 site across 1 country: Syria

Source: ClinicalTrials.gov record NCT03428282. Inclusion in this directory is not an endorsement.