Comparing Augmented Reality and Virtual Reality Glasses to Help Children Feel Less Pain and Anxiety During Local Anesthesia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-8
SponsorRiham Abbas
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Augmented Reality Glasses
DeviceThe child will wear the augmented reality glass, and a cartoon movie will be displayed during the injection of local anesthesia
Virtual Reality Glasses
DeviceThe child will wear the glass, and a cartoon movie will be displayed during the injection of local anesthesia.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Maxillary right primary molarsActive comparator 2 interventions
Group B: Maxillary left primary molarsActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Evaluation of pain perception and anxiety before and after local anesthesia administration using augmented reality glasses in 5-8-year-old children
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").
Time frame
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
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").
Time frame
Pain perception will be assessed from needle insertion to completion of injection (1 minute) of local anesthesia.Secondary outcomes
1
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 (salivary cortisol) will be assessed using enzyme linked immunoassay (ELISA) technique.
Time frame
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.2
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 (salivary alpha amylase) will be assessed using enzyme linked immunoassay (ELISA) technique.
Time frame
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.3
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
The physiological measures of heart rate will be used to evaluate the anxiety using pulse oximeter.
Time frame
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 glasses4
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
The physiological measures of oxygen saturation will be used to evaluate the anxiety using pulse oximeter.
Time frame
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 glassesSponsors and contacts
Click on the lead sponsor to view all of their trials.
Riham Abbas
Lead sponsor
Ain Shams University
Sponsor institution
Source ClinicalTrials.gov