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

Riham Abbas

Status: Enrolling

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

Treatments: Device: Virtual Reality Glasses; Device: Augmented Reality Glasses

Study type: Interventional

Funder types: Other

Identifiers

NCT07060170

FDASU-Rec IM012411

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 5 to 8 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Maxillary right primary molars

Active Comparator group

Description:

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

Treatment:

Device: Augmented Reality Glasses

Device: Virtual Reality Glasses

Maxillary left primary molars

Active Comparator group

Description:

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

Treatment:

Device: Augmented Reality Glasses

Device: Virtual Reality Glasses