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

Not Applicable

Recruiting

• Conditions: Dental Anxiety; Dental Fear; Dental Fear and Anxiety

• Registration Number: NCT07060170
• Lead Sponsor: Riham Abbas

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-01
• Study First Submitted: 2025-02-24
• Study First Submitted QC: 2025-07-09
• Last Update Submitted: 2025-07-09
• Study First Posted: 2025-07-11
• Last Update Posted: 2025-07-11
• Primary Completion: 2025-07-31
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. 5-8 year-old female and male patients.
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

1. Patients with special health care needs.
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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Evaluation of pain perception and anxiety before and after local anesthesia administration using augmented reality glasses in 5-8-year-old children	Pain perception will be assessed from needle insertion to completion of injection (1 minute) of local anesthesia.	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").

Secondary Outcome Measures

Name	Time	Method
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 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.	Salivary stress biomarker (salivary cortisol) will be assessed using enzyme linked immunoassay (ELISA) technique.
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 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.	Salivary stress biomarker (salivary alpha amylase) will be assessed using enzyme linked immunoassay (ELISA) technique.
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	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	The physiological measures of heart rate will be used to evaluate the anxiety using pulse oximeter.
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	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	The physiological measures of oxygen saturation will be used to evaluate the anxiety using pulse oximeter.

Trial Locations

Locations (1)

Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Ain Shams University, Cairo, Egypt; 🇪🇬 Cairo, Egypt