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Completed

NCT Number: NCT05129943

Efficacy of VR Distraction During Local Anesthesia in Children

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.

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Key information

Conditions

Virtual Reality Anesthesia, Local Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tishreen university

Latakia, Syria

About this study

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:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

active distraction

Device

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.

passive distraction

Device

The subject receives the injection of local anesthesia while watching a cartoon on a mobile phone mounted on the VR device.

Primary outcomes

  1. dental pain

    Time frame: during the injection of local anesthesia

    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).

  2. 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

  1. dental pain and anxiety

    Time frame: during the injection of local anesthesia

    using mi band 3 to recording the pulse

Sponsors and collaborators

Lead sponsor

Latakia University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 22, 2021
Registry last updated
Jul 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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