Clinical trial NCT05129943: Efficacy of VR Distraction During Local Anesthesia in Children
Official title: Efficacy of Active and Passive Virtual Reality Distraction During Local Anesthesia in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Virtual Reality
Anesthesia, Local
Pain
Keywords: virtual reality
local anesthesia
pain
distraction
Lead sponsor: Tishreen University
Sponsor class: OTHER
First posted: 2021-11-22
Enrollment: 82
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the participants will be divided into ( active distraction group) and ( passive distraction group )
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: dental pain
timeFrame: during the injection of local anesthesia
measure: dental pain
timeFrame: Immediately after the injection of local anesthesia
Secondary outcomes:
measure: dental pain and anxiety
timeFrame: during the injection of local anesthesia
Other outcomes:
Locations:
city: Latakia
country: Syrian Arab Republic
facility: Tishreen university
Study officials:
affiliation: Tishreen University
name: oula kara Mohammed, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Tishreen University
name: Nabih Raslan, Dr.
role: STUDY_CHAIR
References: