Comparing Augmented Reality and Virtual Reality Glasses to Help Children Feel Less Pain and Anxiety During Local Anesthesia

Официальное название

The Effect of Augmented Reality Versus Virtual Reality Glasses as Distraction Techniques in Children During the Administration of Local Anesthesia A Randomized Clinical Trial

Обзор

The goal of this clinical trial is to learn if audio-visual method of distraction is useful to control the pain and fear associated with dental treatment in children. The main questions it aims to answer are: • How their body reacts-such as changes in heart rate, oxygen levels, and certain chemicals in their saliva-before and after getting local anesthesia? Researchers will test two types of glasses that display cartoons to help children feel less anxious. Participants will: * Have an introductory visit to be more familiar with dental environment and their cooperation will be tested. * In the next 2 visits they will wear either of the glasses while receiving local anesthesia * Saliva will be collected, and their heart rate and oxygen levels will be calculated each time

Вмешательства

• Устройство Augmented Reality Glasses
  The child will wear the augmented reality glass, and a cartoon movie will be displayed during the injection of local anesthesia
• Устройство Virtual Reality Glasses
  The child will wear the glass, and a cartoon movie will be displayed during the injection of local anesthesia.

Первичные конечные точки

• Evaluation of pain perception and anxiety before and after local anesthesia administration using augmented reality glasses in 5-8-year-old children [Срок оценки: Pain perception will be assessed immediately before, and immediately after local anesthetics administration.]
• Evaluation of pain perception and anxiety before and after local anesthesia administration using augmented reality glasses in 5-8-year-old children [Срок оценки: Pain perception will be assessed from needle insertion to completion of injection (1 minute) of local anesthesia.]

Вторичные конечные точки (4)

• Changes in the levels of the salivary cortisol, of 5-8-year-old children before and after the administration of local anesthesia using augmented reality glasses as a distraction [Срок оценки: Salivary stress biomarker will be assessed at baseline, and 20 minutes after local anesthetics administration while the child is distracted using either augmented reality glasses or virtual reality glasses.]
• Changes in the levels of the salivary alpha amylase, of 5-8-year-old children before and after the administration of local anesthesia using augmented reality glasses as a distraction [Срок оценки: Salivary stress biomarker will be assessed at baseline, and 20 minutes after local anesthetics administration while the child is distracted using either augmented reality glasses or virtual reality glasses.]
• Changes in the heart rate of 5-8-year-old children before, during, and after the administration of local anesthesia using either augmented or virtual reality glasses as a distraction [Срок оценки: Heart rate and oxygen saturation will be assessed at baseline, at the onset anesthesia administrating, and one minute after local anesthetics administration while the child is distracted using either augmented reality glasses or virtual reality glasses]
• Changes in the oxygen saturation of 5-8-year-old children before, during, and after the administration of local anesthesia using either augmented or virtual reality glasses as a distraction [Срок оценки: Oxygen saturation will be assessed at baseline, at the onset anesthesia administrating, and one minute after local anesthetics administration while the child is distracted using either augmented reality glasses or virtual reality glasses]

Критерии участия

Критерии включения

• 5-8 year-old female and male patients.
• Cooperative patients (rating 3 or 4 on the Frankl's Behavior Rating Scale).
• American Society of Anesthesiologists (ASA) Class (I).
• Patients need dental treatment under local anesthetic infiltration.
• Patients without known anxiety disorders.
• Patients with body weight that is considered normal according to their age and gender (95th percentile growth curve).
• Patients without a prior history of receiving local anesthetic.
• Patients with at least one vital primary molar with deep carious lesion on each side of the dental arch, who require to be treated under local anesthesia

Критерии исключения

• Patients with special health care needs.
• Patients on corticosteroid medications.
• Patients having known salivary disorders, such as Sjogren's syndrome.
• Parents who refused to sign the informed consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Египет · 1 центр

• Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Ain Shams U — Cairo

Публикации

• Singh Y, Parameshwarappa P, Mathew MG, Meghana SB, Kenchappa M, Nagaveni NB. Comparison of distraction techniques using salivary biomarkers during local anaesthesia administration in children aged 3-5 years: A clinical study. Indian J Dent Res. 2023 Apr-Jun;34(2):169-173. doi: 10.4103/ijdr.ijdr_132_22. PMID 37787206
• Subramaniam SD, Doss B, Chanderasekar LD, Madhavan A, Rosary AM. Scope of physiological and behavioural pain assessment techniques in children - a review. Healthc Technol Lett. 2018 Jul 17;5(4):124-129. doi: 10.1049/htl.2017.0108. eCollection 2018 Aug. PMID 30155264
• Sharma Y, Bhatia HP, Sood S, Sharma N, Singh A. Effectiveness of Virtual Reality Glasses Digital Screens and Verbal Command as a Method to Distract Young Patients during Administration of Local Anesthesia. Int J Clin Pediatr Dent. 2021;14(Suppl 2):S143-S147. doi: 10.5005/jp-journals-10005-2094. PMID 35645477
• Rao DG, Havale R, Nagaraj M, Karobari NM, Latha AM, Tharay N, Shrutha SP. Assessment of Efficacy of Virtual Reality Distraction in Reducing Pain Perception and Anxiety in Children Aged 6-10 Years: A Behavioral Interventional Study. Int J Clin Pediatr Dent. 2019 Nov-Dec;12(6):510-513. doi: 10.5005/jp-journals-10005-1694. PMID 32440065
• Asl Aminabadi N, Erfanparast L, Sohrabi A, Ghertasi Oskouei S, Naghili A. The Impact of Virtual Reality Distraction on Pain and Anxiety during Dental Treatment in 4-6 Year-Old Children: a Randomized Controlled Clinical Trial. J Dent Res Dent Clin Dent Prospects. 2012 Fall;6(4):117-24. doi: 10.5681/joddd.2012.025. Epub 2012 Nov 12. PMID 23277857

Идентификаторы

NCT: NCT07060170 · FDASU-Rec IM012411

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗