Efficacy of VR Distraction During Local Anesthesia in Children

Study Overview
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Brief Summary
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The aim of this study is to compare between active distraction (video game) and passive distraction (cartoon video) using a Virtual Reality ( VR ) device, in reducing injection pain and anxiety associated with local anesthesia in children.

Detailed Description
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This comparative study is a double blinded controlled randomized clinical trial which includes 82 healthy 6-10 years old children with positive and definitely positive behavior according to Frankl Rating Scale with no known allergy to local anesthesia, no emergency dental treatment, no previous treatment from the same researcher and no previous experience in using the Virtual Reality ( VR ) device. the participants will be allocated and treated at department of pediatric dentistry, faculty of dentistry, Tishreen university and a written consent will be obtained from the parents. The random-numbers table will be used to divide 82 participants in to two groups: The active distraction group, which will be receiving the injection of local anesthesia while using the VR device with a video game and a Play Station 4 ( PS4 ) controller. The passive distraction group, which will be receiving the injection of local anesthesia while using VR device watching a cartoon video. All the participants will receive an inferior alveolar nerve block with semi supine position.

Official Title
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Efficacy of Active and Passive Virtual Reality Distraction During Local Anesthesia in Children

Conditions
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Virtual Reality, Anesthesia, Local, Pain

Intervention / Treatment
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* Device: active distraction
* Device: passive distraction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy children need a simple treatment for temporary teeth in the mandibular jaw children with positive and definitely positive behavior according to frankl behavior classification children with no known allergy to local anesthesia children with no previous treatment from the same researcher children with no previous experience in using the VR device Exclusion Criteria: children with negative and definitely negative behavior according to frankl behavior classification children with known allergy to local anesthesia children with emergency dental treatment in the mandibular jaw children with previous treatment from the same researcher

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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Accepts Healthy Volunteers

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
Interventional Model Description: the participants will be divided into ( active distraction group) and ( passive distraction group )
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: active distraction group<br>local anesthesia with video game using VR device | Device: active distraction<br>* The subject receives the injection of local anesthesia while playing a game on a mobile phone mounted on the VR device using a PS4 controller.<br>|
| Active Comparator: passive distraction group<br>local anesthesia with cartoon video using VR device | Device: passive distraction<br>* The subject receives the injection of local anesthesia while watching a cartoon on a mobile phone mounted on the VR device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dental pain | evaluated by outcome assessor using the Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale ( FLACC scale ) ( a behavioral pain assessment scale which has five criteria face, legs, activity, cry, consolability ,which are each assigned a score of 0, 1 or 2.Total score of scale is summed in range 0 to 10, where: 0=relaxed and comfortable; 1-3=mild discomfort; 4-6=moderate pain; 7-10=severe pain). | during the injection of local anesthesia | 
| dental pain | self assessment pain by the children using Wong-Baker faces pain rating scale (a scale shows a series of faces ranging from a happy face at 0, or no hurt, to a crying face at 10,which represents hurts like the worst pain imaginable ) | Immediately after the injection of local anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dental pain and anxiety | using mi band 3 to recording the pulse | during the injection of local anesthesia | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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virtual reality, local anesthesia, pain, distraction