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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Inferior Alveolar Nerve Block

Intervention / Treatment
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* Procedure: VR Box
* Procedure: Tablet Device
* Drug: Anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 6 and 10 years. no previous dental experience. definitely positive or positive ratings of Frank scale. Need of IAN block for any dental treatment. Exclusion Criteria: previous dental experience systematic or mental disorders. definitely negative or negative ratings of Frankel scale Any contraindication for regional anesthesia

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VR Box<br>Inferior alveolar nerve block will be performed with the aid of VR box as a means of distracting patients' attention. | Procedure: VR Box<br>* Distraction will be made during the injection of the drug using this method.<br>* Other names: Virtual Reality Eyeglasses;|
| Experimental: Tablet device<br>Inferior alveolar nerve block will be performed with the aid of a tablet device as a means of distracting patients' attention. | Procedure: Tablet Device<br>* Distraction will be made during the injection of the drug using this method<br>|
| Active Comparator: Anesthesia<br>Inferior alveolar nerve block will be performed in the normal manner without any specific intervention to distract patients' attention. Classic anesthesia will be applied. | Drug: Anesthesia<br>* Anesthesia will be obtained by injecting the drug into the oral mucosa before performing the dental treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain levels | using self-reported Wong-Baker FACES pain scale with 0 indicating 'no pain' and five indicating 'worst pain'. | five minutes following the inferior alveolar nerve block injection. | 
| Anxiety levels | This will be evaluated using the Face-Legs-Activity-Cry-Consolability (FLACC) scale employing an external evaluator in which all of the body responses will be recorded once the needle penetrate the oral tissue. (0 low anxiety and pain level - 10 high anxiety and pain level) | Within the first minute of injecting the needle into the oral mucosa (oral tissues). | 
| Change in physiological pulse rate | using Finger Pulse Oximeter | (1) five minutes after the patient is seated comfortably on the dental chair, (2) five minutes following the injection of the anesthetic drug |