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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maxillary right primary molars | Active Comparator | In this Split-mouth Randomized Controlled Trial, 5-8-year-old female and male children will be enrolled. They will receive local anesthesia on the right side of the arch using one of the distraction methods, then after one to two weeks they will receive local anesthesia on other side of the arch using a different distraction method |
|
| Maxillary left primary molars | Active Comparator | In this Split-mouth Randomized Controlled Trial, 5-8-year-old female and male children will be enrolled. They will receive local anesthesia on the left side of the arch using one of the distraction methods, then after one to two weeks they will receive local anesthesia on other side of the arch using a different distraction method |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Augmented Reality Glasses | Device | The child will wear the augmented reality glass, and a cartoon movie will be displayed during the injection of local anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of pain perception and anxiety before and after local anesthesia administration using augmented reality glasses in 5-8-year-old children | The Wong-Baker FACES Pain Rating Scale Arabic Version, will be used to subjectively assess the pain perception before and after local anesthetics administration, the scale uses cartoon faces representing pain levels from 0 ("no pain") to 10 ("worst pain imaginable"). | 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 | The face, legs, activity, cry, consolability (FLACC) behavioral pain assessment scale will be used to objectively assess the pain perception during local anesthetics administration, this scale consists of 5 categories, each category is scored from 0 to 2, with a total score ranging from 0 ("relaxed and comfortable") to 10 ("sever discomfort or pain or both"). | Pain perception will be assessed from needle insertion to completion of injection (1 minute) of local anesthesia. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Salivary stress biomarker (salivary cortisol) will be assessed using enzyme linked immunoassay (ELISA) technique. | 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. |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Master's Degree Candidate | Contact | 1554566997 | +20 | rihamamir@dent.asu.edu.eg |
| Riham A Abbas, Master's degree Candidate | Contact | rihamamir@dent.asu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Professor of Pediatric Dentistry and Dental Public Health | Faculty of Dentistry, Ain Shams University | Study Director |
| Lecturer of Pediatric Dentistry and Dental Public Health | Faculty of Dentistry, Ain Shams University |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Ain Shams University, Cairo, Egypt | Recruiting | Cairo | Egypt | 11566 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37787206 | Result | 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. | |
| 30155264 | Result |
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Faculty of Dentistry Ain Shams University Research Ethics Committee, state that data will not be shared to preserve the confidentiality.
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Teeth in each patient will be randomly assigned to receive both interventions sequentially, using a simple randomization technique. Each time a new patient is to be enrolled in the study, he\she will be asked to select a sequentially numbered sealed opaque envelop that determines which type of distraction method will be implemented first. In the subsequent treatment visit, the other distraction technique will be automatically applied, since this is a split mouth designed study.
A set of 40 envelopes (20 envelopes for augmented reality glasses and 20 envelops for virtual reality glasses) will be kept with a third party (the main supervisor), who will not be involved in the data collection, to ensure allocation concealment.
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The main supervisor will code the patients' tooth allocation in order to blind the statistician and the clinical pathologist who will assess the salivary biomarker levels in the samples.
| Virtual Reality Glasses | Device | The child will wear the glass, and a cartoon movie will be displayed during the injection of local anesthesia. |
|
| 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 | Salivary stress biomarker (salivary alpha amylase) will be assessed using enzyme linked immunoassay (ELISA) technique. | 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 | The physiological measures of heart rate will be used to evaluate the anxiety using pulse oximeter. | 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 | The physiological measures of oxygen saturation will be used to evaluate the anxiety using pulse oximeter. | 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 |
| 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. |
| 35645477 | Result | 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. |
| 32440065 | Result | 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. |
| 23277857 | Result | 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. |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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