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Clinical Trials/NCT05129943
NCT05129943
Completed
Not Applicable

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

Tishreen University1 site in 1 country82 target enrollmentFebruary 21, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Virtual Reality
Sponsor
Tishreen University
Enrollment
82
Locations
1
Primary Endpoint
dental pain
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 21, 2022
End Date
July 5, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

dental pain

Time Frame: 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 Outcomes

  • dental pain and anxiety(during the injection of local anesthesia)

Study Sites (1)

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