Efficacy of VR Distraction During Local Anesthesia in Children

NCT ID: NCT05129943

Last Updated: 2022-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-21

Study Completion Date

2022-07-05

Brief Summary

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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

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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.

Conditions

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Virtual Reality Anesthesia, Local Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

the participants will be divided into ( active distraction group) and ( passive distraction group )
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
the participants will carry the controller with a box to hide the controller (to keep the outcomes assessor blinded) and wear the VR device by an assistant ( to keep investigator blinded).

Study Groups

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active distraction group

local anesthesia with video game using VR device

Group Type ACTIVE_COMPARATOR

active distraction

Intervention Type 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 group

local anesthesia with cartoon video using VR device

Group Type ACTIVE_COMPARATOR

passive distraction

Intervention Type DEVICE

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

Interventions

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active 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.

Intervention Type DEVICE

passive distraction

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tishreen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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oula kara Mohammed, DDS

Role: PRINCIPAL_INVESTIGATOR

Tishreen University

Nabih Raslan, Dr.

Role: STUDY_CHAIR

Tishreen University

Locations

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Tishreen university

Latakia, , Syria

Site Status

Countries

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Syria

Other Identifiers

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VR distraction in children

Identifier Type: -

Identifier Source: org_study_id

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