Dental AnxietyNCT07060170
Comparing Augmented Reality and Virtual Reality Glasses to Help Children Feel Less Pain and Anxiety During Local Anesthesia
A study testing Augmented Reality Glasses and Virtual Reality Glasses in people with Dental Anxiety and Dental Fear, run by Riham Abbas at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety, Dental Fear, Dental Fear and Anxiety
- What is being tested?
- Augmented Reality Glasses and Virtual Reality Glasses
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Riham A Abbas, Master's degree Candidate contact
Egypt1 site, 1 recruiting
- Recruiting
Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Ain Shams University, Cairo, Egypt
Cairo, Egypt, 11566
Professor of Pediatric Dentistry and Dental Public Health, 1006506028 ext. +20, mariem.wassel@dent.asu.edu.eg
Master's Degree Candidate, 1554566997 ext. +20, rihamamir@dent.asu.edu.eg
About this study
Official title: The Effect of Augmented Reality Versus Virtual Reality Glasses as Distraction Techniques in Children During the Administration of Local Anesthesia A Randomized Clinical 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.
Read more
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
- Conditions
- Dental Anxiety, Dental Fear, Dental Fear and Anxiety
- Being tested
- Augmented Reality Glasses, Virtual Reality Glasses
- Keywords
- salivary alpha amylase, dental anxiety, cortisol, Virtual Reality, Local Anesthesia, child, Behavior
- Medical subject headings
- Anxiety Disorders, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented Reality GlassesDevice
The child will wear the augmented reality glass, and a cartoon movie will be displayed during the injection of local anesthesia
Virtual Reality GlassesDevice
The child will wear the glass, and a cartoon movie will be displayed during the injection of local anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Maxillary right primary molars | Active comparator | 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 Receives: Device: Augmented Reality Glasses; Device: Virtual Reality Glasses |
| Maxillary left primary molars | Active comparator | 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 Receives: Device: Augmented Reality Glasses; Device: Virtual Reality Glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: Pain perception will be assessed immediately before, and immediately after local anesthetics administration.
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").
Measured: Pain perception will be assessed from needle insertion to completion of injection (1 minute) of local anesthesia.
Secondary outcomes (4)
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start1 Dec 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riham Abbas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Riham Abbas, Ain Shams University
- Investigators
- Professor of Pediatric Dentistry and Dental Public Health, Study director, Faculty of Dentistry, Ain Shams UniversityLecturer of Pediatric Dentistry and Dental Public Health, Study director, Faculty of Dentistry, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060170
- Sponsor's protocol ID
- FDASU-Rec IM012411
- Status last verified
- Dec 2024
- First submitted
- 24 Feb 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Faculty of Dentistry Ain Shams University Research Ethics Committee, state that data will not be shared to preserve the confidentiality.
Publications
Singh Y, Parameshwarappa P, Mathew MG, Meghana SB, Kenchappa M, Nagaveni NB. Comparison of distraction techniques using salivary biomarkers during local anaesthesia administration in children aged 3-5 years: A clinical study. Indian J Dent Res. 2023 Apr-Jun;34(2):169-173. doi: 10.4103/ijdr.ijdr_132_22.
PubMed 37787206Subramaniam SD, Doss B, Chanderasekar LD, Madhavan A, Rosary AM. Scope of physiological and behavioural pain assessment techniques in children - a review. Healthc Technol Lett. 2018 Jul 17;5(4):124-129. doi: 10.1049/htl.2017.0108. eCollection 2018 Aug.
PubMed 30155264Sharma Y, Bhatia HP, Sood S, Sharma N, Singh A. Effectiveness of Virtual Reality Glasses Digital Screens and Verbal Command as a Method to Distract Young Patients during Administration of Local Anesthesia. Int J Clin Pediatr Dent. 2021;14(Suppl 2):S143-S147. doi: 10.5005/jp-journals-10005-2094.
PubMed 35645477Rao DG, Havale R, Nagaraj M, Karobari NM, Latha AM, Tharay N, Shrutha SP. Assessment of Efficacy of Virtual Reality Distraction in Reducing Pain Perception and Anxiety in Children Aged 6-10 Years: A Behavioral Interventional Study. Int J Clin Pediatr Dent. 2019 Nov-Dec;12(6):510-513. doi: 10.5005/jp-journals-10005-1694.
PubMed 32440065Asl Aminabadi N, Erfanparast L, Sohrabi A, Ghertasi Oskouei S, Naghili A. The Impact of Virtual Reality Distraction on Pain and Anxiety during Dental Treatment in 4-6 Year-Old Children: a Randomized Controlled Clinical Trial. J Dent Res Dent Clin Dent Prospects. 2012 Fall;6(4):117-24. doi: 10.5681/joddd.2012.025. Epub 2012 Nov 12.
PubMed 23277857
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Augmented Reality Versus Virtual Reality Glasses as Distraction Techniques in Children During the Administration of Local Anesthesia A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07060170
- Acronym / sponsor ID
- FDASU-Rec IM012411
- Conditions
- Dental Anxiety, Dental Fear, Dental Fear and Anxiety
- Keywords
- salivary alpha amylase, dental anxiety, cortisol, Virtual Reality, Local Anesthesia, child, Behavior
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Riham AbbasUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Maxillary right primary molars | Active comparator | Device: Augmented Reality Glasses, Device: Virtual Reality GlassesIn 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 |
| Maxillary left primary molars | Active comparator | Device: Augmented Reality Glasses, Device: Virtual Reality GlassesIn 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 |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Augmented Reality GlassesThe child will wear the augmented reality glass, and a cartoon movie will be displayed during the injection of local anesthesia | Device | Maxillary left primary molars, Maxillary right primary molars |
| Virtual Reality GlassesThe child will wear the glass, and a cartoon movie will be displayed during the injection of local anesthesia. | Device | Maxillary left primary molars, Maxillary right primary molars |
Primary outcome
Evaluation of pain perception and anxiety before and after local anesthesia administration using augmented reality glasses in 5-8-year-old children
Time frame: 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").
Evaluation of pain perception and anxiety before and after local anesthesia administration using augmented reality glasses in 5-8-year-old children
Time frame: 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").
4 secondary outcomes
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
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.
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
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.
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
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 glasses
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
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 glasses
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Results publication: PubMed 37787206Singh Y, Parameshwarappa P, Mathew MG, Meghana SB, Kenchappa M, Nagaveni NB. Comparison of distraction techniques using salivary biomarkers during local anaesthesia administration in children aged 3-5 years: A clinical study. Indian J Dent Res. 2023 Apr-Jun;34(2):169-173. doi: 10.4103/ijdr.ijdr_132_22.
- Results publication: PubMed 30155264Subramaniam SD, Doss B, Chanderasekar LD, Madhavan A, Rosary AM. Scope of physiological and behavioural pain assessment techniques in children - a review. Healthc Technol Lett. 2018 Jul 17;5(4):124-129. doi: 10.1049/htl.2017.0108. eCollection 2018 Aug.
- Results publication: PubMed 35645477Sharma Y, Bhatia HP, Sood S, Sharma N, Singh A. Effectiveness of Virtual Reality Glasses Digital Screens and Verbal Command as a Method to Distract Young Patients during Administration of Local Anesthesia. Int J Clin Pediatr Dent. 2021;14(Suppl 2):S143-S147. doi: 10.5005/jp-journals-10005-2094.
- Results publication: PubMed 32440065Rao DG, Havale R, Nagaraj M, Karobari NM, Latha AM, Tharay N, Shrutha SP. Assessment of Efficacy of Virtual Reality Distraction in Reducing Pain Perception and Anxiety in Children Aged 6-10 Years: A Behavioral Interventional Study. Int J Clin Pediatr Dent. 2019 Nov-Dec;12(6):510-513. doi: 10.5005/jp-journals-10005-1694.
- Results publication: PubMed 23277857Asl Aminabadi N, Erfanparast L, Sohrabi A, Ghertasi Oskouei S, Naghili A. The Impact of Virtual Reality Distraction on Pain and Anxiety during Dental Treatment in 4-6 Year-Old Children: a Randomized Controlled Clinical Trial. J Dent Res Dent Clin Dent Prospects. 2012 Fall;6(4):117-24. doi: 10.5681/joddd.2012.025. Epub 2012 Nov 12.
- Individual participant dataSharing planned: No. Faculty of Dentistry Ain Shams University Research Ethics Committee, state that data will not be shared to preserve the confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Riham A Abbas, Master's degree Candidate contact
Professor of Pediatric Dentistry and Dental Public Health study director
Faculty of Dentistry, Ain Shams University
Lecturer of Pediatric Dentistry and Dental Public Health study director
Faculty of Dentistry, Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented Reality Glasses and Virtual Reality Glasses in people with Dental Anxiety and Dental Fear, run by Riham Abbas at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Master's Degree Candidate (1554566997 ext. +20, rihamamir@dent.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of pain perception and anxiety before and after local anesthesia administration using augmented reality glasses in 5-8-year-old children (time frame: Pain perception will be assessed immediately before, and immediately after local anesthetics administration.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07060170, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.