Efficacy of VR Distraction During Local Anesthesia in Children

NCT05129943 | Completed

• 1 other identifier: VR distraction in children
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Virtual Reality; Anesthesia, Local; Pain

Keywords

virtual reality; local anesthesia; pain; distraction

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• dental pain and anxiety

  during the injection of local anesthesia

Study Arms (2)

active distraction group

ACTIVE COMPARATOR

local anesthesia with video game using VR device

Device: active distraction

passive distraction group

ACTIVE COMPARATOR

local anesthesia with cartoon video using VR device

Device: passive distraction

Interventions

active distraction 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.

active distraction group

passive distraction DEVICE

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

passive distraction group

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tishreen University: lead

Study Sites (1)

Tishreen university

Latakia, Syria

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• oula kara Mohammed, DDS

  Tishreen University

  PRINCIPAL INVESTIGATOR

• Nabih Raslan, Dr.

  Tishreen University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: the participants will be divided into ( active distraction group) and ( passive distraction group )

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: November 22, 2021
• Study Start: February 21, 2022
• Primary Completion: June 24, 2022
• Study Completion: July 5, 2022
• Last Updated: July 14, 2022

Record last verified: 2022-02

Locations

SY (1)