Efficacy of VR Distraction During Local Anesthesia in Children

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05129943
• Other study ID #: VR distraction in children
• Status: Completed
• Phase: N/A
• Start date: February 21, 2022
• Est. completion date: July 5, 2022

Study information

• Verified date: February 2022
• Source: Tishreen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: July 5, 2022
• Est. primary completion date: June 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Local
• Pain
• Virtual Reality

Intervention

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

Locations

Country	Name	City	State
Syrian Arab Republic	Tishreen university	Latakia

Sponsors (1)

Lead Sponsor	Collaborator
Tishreen University

Country where clinical trial is conducted

Syrian Arab Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dental pain	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).	during the injection of local anesthesia
Primary	dental pain	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" )	Immediately after the injection of local anesthesia
Secondary	dental pain and anxiety	using mi band 3 to recording the pulse	during the injection of local anesthesia