An interventional study of active distraction and passive distraction in Virtual Reality, Anesthesia, Local and Pain, sponsored by Latakia University. Completed at 1 site in Syria. Open to participants aged 6 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-14.
Sponsored by Latakia University · Not applicable, Interventional, and Treatment
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:
All the participants will receive an inferior alveolar nerve block with semi supine position.
2,450 studies on the registry are indexed under Pain; 945 are open to participants now.
This study's enrollment of 82 is above the median of 70 across 2,101 interventional studies indexed under Pain.
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Exclusion Criteria:
local anesthesia with video game using VR device
Device: active distraction
local anesthesia with cartoon video using VR device
Device: passive distraction
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.
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
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Latakia University