Comparing Augmented Reality and Virtual Reality Glasses to Help Children Feel Less Pain and Anxiety During Local Anesthesia
NCT ID: NCT07060170
Last Updated: 2025-07-11
Study Results
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Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2024-12-01
2025-08-30
Brief Summary
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• 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
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.
SUPPORTIVE_CARE
SINGLE
Study Groups
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Maxillary right primary molars
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
Augmented Reality Glasses
The child will wear the augmented reality glass, and a cartoon movie will be displayed during the injection of local anesthesia
Virtual Reality Glasses
The child will wear the glass, and a cartoon movie will be displayed during the injection of local anesthesia.
Maxillary left primary molars
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
Augmented Reality Glasses
The child will wear the augmented reality glass, and a cartoon movie will be displayed during the injection of local anesthesia
Virtual Reality Glasses
The child will wear the glass, and a cartoon movie will be displayed during the injection of local anesthesia.
Interventions
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Augmented Reality Glasses
The child will wear the augmented reality glass, and a cartoon movie will be displayed during the injection of local anesthesia
Virtual Reality Glasses
The child will wear the glass, and a cartoon movie will be displayed during the injection of local anesthesia.
Eligibility Criteria
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Inclusion Criteria
2. Cooperative patients (rating 3 or 4 on the Frankl's Behavior Rating Scale).
3. American Society of Anesthesiologists (ASA) Class (I).
4. Patients need dental treatment under local anesthetic infiltration.
5. Patients without known anxiety disorders.
6. Patients with body weight that is considered normal according to their age and gender (95th percentile growth curve).
7. Patients without a prior history of receiving local anesthetic.
8. 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
Exclusion Criteria
2. Patients on corticosteroid medications.
3. Patients having known salivary disorders, such as Sjogren's syndrome.
4. Parents who refused to sign the informed consent.
5 Years
8 Years
ALL
Yes
Sponsors
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Riham Abbas
OTHER
Responsible Party
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Riham Abbas
General practitioner
Principal Investigators
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Professor of Pediatric Dentistry and Dental Public Health
Role: STUDY_DIRECTOR
Faculty of Dentistry, Ain Shams University
Lecturer of Pediatric Dentistry and Dental Public Health
Role: STUDY_DIRECTOR
Faculty of Dentistry, Ain Shams University
Locations
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Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Ain Shams University, Cairo, Egypt
Cairo, Egypt, Egypt
Countries
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Central Contacts
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Facility Contacts
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Professor of Pediatric Dentistry and Dental Public Health
Role: primary
References
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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.
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.
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.
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.
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.
Other Identifiers
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FDASU-Rec IM012411
Identifier Type: -
Identifier Source: org_study_id
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