Dental Anxiety, Dental Fear, Dental Fear and Anxiety
Conditions
Keywords
salivary alpha amylase, dental anxiety, cortisol, Virtual Reality, Local Anesthesia, child, Behavior
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
Interventions
The child will wear the augmented reality glass, and a cartoon movie will be displayed during the injection of local anesthesia
DEVICEVirtual Reality Glasses
The child will wear the glass, and a cartoon movie will be displayed during the injection of local anesthesia.
Sponsors
Riham Abbas
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
The main supervisor will code the patients' tooth allocation in order to blind the statistician and the clinical pathologist who will assess the salivary biomarker levels in the samples.
Intervention model description
Teeth in each patient will be randomly assigned to receive both interventions sequentially, using a simple randomization technique. Each time a new patient is to be enrolled in the study, he\\she will be asked to select a sequentially numbered sealed opaque envelop that determines which type of distraction method will be implemented first. In the subsequent treatment visit, the other distraction technique will be automatically applied, since this is a split mouth designed study. 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.
Eligibility
Sex/Gender
ALL
Age
5 Years to 8 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 immediately before, and immediately after local anesthetics administration. | The Wong-Baker FACES Pain Rating Scale Arabic Version, will be used to subjectively assess the pain perception before and after local anesthetics administration, the scale uses cartoon faces representing pain levels from 0 (no pain) to 10 (worst pain imaginable). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Egypt
Contacts
Primary ContactMaster's Degree Candidate
Backup ContactRiham A Abbas, Master's degree Candidate
Outcome results
None listed