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 range5 Years – 8 Years
SexALL
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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.
✓. 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.
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.