Efficacy of VR Distraction During Local Anesthesia in Children

Not Applicable

Completed

• Conditions: Anesthesia, Local; Virtual Reality; Pain
• Interventions: Device: active distraction; Device: passive distraction

• Registration Number: NCT05129943
• Lead Sponsor: Tishreen University

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-11-11
• Study First Submitted QC: 2021-11-11
• Study First Posted: 2021-11-22
• Status Verified: 2022-02
• Study Start: 2022-02-21
• Primary Completion: 2022-06-24
• Study Completion: 2022-07-05
• Last Update Submitted: 2022-07-12
• Last Update Posted: 2022-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
active distraction group	active distraction	local anesthesia with video game using VR device
passive distraction group	passive distraction	local anesthesia with cartoon video using VR device

Primary Outcome Measures

Name	Time	Method
dental pain	Immediately after the injection of local anesthesia	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" )

Secondary Outcome Measures

Name	Time	Method
dental pain and anxiety	during the injection of local anesthesia	using mi band 3 to recording the pulse

Trial Locations

Locations (1)

Tishreen university; 🇸🇾 Latakia, Syrian Arab Republic