NCT05129943

Efficacy of VR Distraction During Local Anesthesia in Children

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Tishreen University · Academic / Other
• Sex: All
• Age: 6 Years – 10 Years
• Healthy volunteers: Accepted

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.

Conditions

• Virtual Reality
• Anesthesia, Local
• Pain

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	passive distraction	The subject receives the injection of local anesthesia while watching a cartoon on a mobile phone mounted on the VR device.

Timeline

• Start date: 2022-02-21
• Primary completion: 2022-06-24
• Completion: 2022-07-05
• First posted: 2021-11-22
• Last updated: 2022-07-14

Locations

1 site across 1 country: Syria