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.
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: 1. 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. 2. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
82
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.
The subject receives the injection of local anesthesia while watching a cartoon on a mobile phone mounted on the VR device.
Tishreen university
Latakia, Syria
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).
Time frame: 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" )
Time frame: Immediately after the injection of local anesthesia
dental pain and anxiety
using mi band 3 to recording the pulse
Time frame: during the injection of local anesthesia
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