Efficacy of VR Distraction During Local Anesthesia in Children

• Sponsor: Tishreen University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05129943
• Collaborator: (none)
• Enrollment: 82
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.4
• Patients Per Site Per Month: 18.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Virtual Reality; Anesthesia, Local; Pain	Device: active distraction; Device: passive distraction	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 82 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: the participants will be divided into ( active distraction group) and ( passive distraction group )the participants will be divided into ( active distraction group) and ( passive distraction group )
• Masking: Double (Investigator, Outcomes Assessor)
• Masking Description: 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).
• Primary Purpose: Treatment
• Official Title: Efficacy of Active and Passive Virtual Reality Distraction During Local Anesthesia in Children
• Actual Study Start Date: Feb 21, 2022
• Actual Primary Completion Date: Jun 24, 2022
• Actual Study Completion Date: Jul 5, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: active distraction group local anesthesia with video game using VR device	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.
Active Comparator: passive distraction group local anesthesia with cartoon video using VR device	Device: passive distraction; The subject receives the injection of local anesthesia while watching a cartoon on a mobile phone mounted on the VR device.

Outcome Measures

Primary Outcome Measures

1. dental pain [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 [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 Outcome Measures

1. dental pain and anxiety [during the injection of local anesthesia]

   using mi band 3 to recording the pulse

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 10 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tishreen university	Latakia		Syrian Arab Republic

Sponsors and Collaborators

• Tishreen University

Investigators

• Principal Investigator: oula kara Mohammed, DDS, Tishreen University
• Study Chair: Nabih Raslan, Dr., Tishreen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tishreen University
• ClinicalTrials.gov Identifier: NCT05129943
• Other Study ID Numbers: VR distraction in children
• First Posted: Nov 22, 2021
• Last Update Posted: Jul 14, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Tishreen University: virtual reality; local anesthesia; pain; distraction

Study Results

No Results Posted as of Jul 14, 2022