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Efficacy of VR Distraction During Local Anesthesia in Children

T

Tishreen University

Status

Completed

Conditions

Anesthesia, Local
Pain
Virtual Reality

Treatments

Device: active distraction
Device: passive distraction

Study type

Interventional

Funder types

Other

Identifiers

NCT05129943
VR distraction in children

Details and patient eligibility

About

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.

Full 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.

Enrollment

82 patients

Sex

All

Ages

6 to 10 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

82 participants in 2 patient groups

active distraction group
Active Comparator group
Description:
local anesthesia with video game using VR device
Treatment:
Device: active distraction
passive distraction group
Active Comparator group
Description:
local anesthesia with cartoon video using VR device
Treatment:
Device: passive distraction

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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