Virtual Reality Distraction in Pediatric Patients.

Effectiveness of Virtual Reality Distraction During Infiltration Anesthesia in Pediatric Patients.

The aim of this study is to evaluate the effect of virtual reality distraction on pain and anxiety during infiltration anesthesia in pediatric patients.

Study Overview

• Status: Not yet recruiting
• Conditions: Virtual Reality; Pediatric Patients; Distraction; Infiltration Anesthesia
• Intervention / Treatment: Device: regular screen; Device: Virtual reality goggles (VR )

Detailed Description

Proper pain control and discomfort reduction during dental treatment, especially among children, can maximize a child's cooperation, overall satisfaction, build a good dentist-patient relationship, and enhance patient compliance. Psychological and pharmaceutical methods, and their combinations have tried to address this pain. Pharmaceutical approaches include the application of topical anesthetics. Psychological and behavioral modification methods including active distractions, deep breathing, Witaul and eye movement distractions. Passive distraction methods, such as audiovisual glasses and video distraction. Other methods, such as precooling the injection site, warming the local anesthesia, and camouflaging the syringe, have also been suggested.

A range of fear management techniques have been described in the literature and American Academy of Pediatric Dentistry (AAPD) has described some concepts as basic behavior guidance such as communication, tell show do, voice control, nonverbal communication, positive reinforcement, distraction and parental absence/presence, and advanced behavior guidance such as protective stabilization, sedation and general anesthesia.

Distraction as a behavior guidance technique is defined by the American Academy of Pediatric Dentistry (AAPD) as the technique of diverting the patient's attention from what may be perceived as an unpleasant procedure.

Audiovisual distraction techniques are used in dental clinics and have shown great results in managing anxious pediatric patients.

Virtual reality (VR) distraction, defined as a human-computer interface that enables the user to interact dynamically with the computer- generated environment is a new method in the medical field with the aim of aiding in patient behavior management. It offers the advantage of an immersive virtual experience blocking out external stimuli that may provoke a negative attitude, especially in young patients.

Distraction using VR provided favorable outcomes for adult and pediatric patients during various dental procedures, ranging from simple anesthesia to periodontal, restorative, and pulpal therapy .

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Rokia Abdelrhman Saad Elfaramawy
      • Contact: Rokia A Elfaramawy, BDS; Phone Number: 01069823221; Email: Rokiaabdelrahman94@gmail.com
      • Sub-Investigator: Fatma A Elhendawy, Professor
      • Sub-Investigator: Nura I Abozena, Lecturer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Healthy children with no systemic illness.
2. Cooperative child with frankels behavior rating scale positive or definitely positive.
3. Patient requiring infiltration LA for dental treatment.
4. Children with proper parental consent.
5. Patients who needed non-urgent dental treatment.

Exclusion Criteria:

1. Medical disability such as history of seizures, convulsion disorder, vertigo, eye problems and autism.
2. Children below 5 years of age.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; Patients will take buccal infiltration anesthesia using (regular screen).	Device: regular screen; Patients will take buccal infiltration anaethesia using (regular screen ).
Experimental: VR group; Patients will take buccal infiltration anesthesia using (Virtual reality goggles).	Device: Virtual reality goggles (VR ); Patients will take buccal infiltration anaethesia using (Virtual reality goggles) that properly adjusted around the patient's head and in front of his/her eyes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of pain during virtual reality distraction	During local anesthesia administration, the face, legs, activity, cry, consolability (FLACC) behavioral pain assessment scale (objective scale) will be recorded to assess pain. Immediately after anesthetic administration, the patients will be placed in upright position and will be shown Wong-Baker faces pain rating scale (subjective scale) and give a brief explanation to the child about each face and instruct the child to choose the face that describe their feeling during administration of local anaethesia	After 2 weeks from the first visit.

Collaborators and Investigators

• Sponsor: Tanta University

Publications and helpful links

General Publications

• Al-Khotani A, Bello LA, Christidis N. Effects of audiovisual distraction on children's behaviour during dental treatment: a randomized controlled clinical trial. Acta Odontol Scand. 2016 Aug;74(6):494-501. doi: 10.1080/00016357.2016.1206211. Epub 2016 Jul 13.
• Kamath PS. A novel distraction technique for pain management during local anesthesia administration in pediatric patients. J Clin Pediatr Dent. 2013 Fall;38(1):45-7. doi: 10.17796/jcpd.38.1.265807t236570hx7.
• Custodio NB, Costa FDS, Cademartori MG, da Costa VPP, Goettems ML. Effectiveness of Virtual Reality Glasses as a Distraction for Children During Dental Care. Pediatr Dent. 2020 Mar 15;42(2):93-102.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: April 4, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2090/10/30

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No