Comparing Augmented Reality and Virtual Reality Glasses to Help Children Feel Less Pain and Anxie… (NCT07060170) | Clinical Trial Compass
RecruitingNot Applicable
Comparing Augmented Reality and Virtual Reality Glasses to Help Children Feel Less Pain and Anxiety During Local Anesthesia
Egypt40 participantsStarted 2024-12-01
Plain-language summary
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
Who can participate
Age range
5 Years – 8 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluation of pain perception and anxiety before and after local anesthesia administration using augmented reality glasses in 5-8-year-old children
Timeframe: Pain perception will be assessed immediately before, and immediately after local anesthetics administration.
2
Evaluation of pain perception and anxiety before and after local anesthesia administration using augmented reality glasses in 5-8-year-old children
Timeframe: Pain perception will be assessed from needle insertion to completion of injection (1 minute) of local anesthesia.
. 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
. 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.