Dental AnxietyNCT07467395
Evaluation of Augmented Reality on Dental Pain and Anxiety During Primary Molars' Extraction
A study testing Augmented reality glasses and VR glasses in people with Dental Anxiety, run by Sara Hazem Mohamed Rabie.
Trial summary
The aim of this study is to evaluate the impact of using virtual reality glasses compared to augmented reality glasses as distraction methods to reduce the dental anxiety and pain in children during extraction of primary molars. Read more about this study
- Who is it for?
- Ages 6 to 8 years
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Augmented reality glasses and VR glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Jul 2026
- 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 6 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Medically free children without visual or auditory impairment (ASA I).
- Children aged 6-8 years.
- Children with Frankl behaviour rating score 3 or 4.
- Children requiring extraction in one of their primary molars.
- Parents who will accept to give their consent and participate in the study
Who cannot join
- Children require emergency dental treatment.
- Children with a history of epilepsy and anxiety disorder.
- Children with previous bad dental experience.
- Allergy to local anaesthetic drugs.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Augmented Reality on Dental Pain and Anxiety During Primary Molars' Extraction: Randomized Controlled Clinical Trial
The aim of this study is to evaluate the impact of using virtual reality glasses compared to augmented reality glasses as distraction methods to reduce the dental anxiety and pain in children during extraction of primary molars.
- Conditions
- Dental Anxiety
- Being tested
- Augmented reality glasses, VR glasses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented reality glassesDevice
Augmented reality glasses will be introduced to the child and he will be allowed to choose his favourite cartoon movie from this list: Rapunzel, Stitch, Ratatouille, Frozen, Minions, Zootopia, and The lion king during the first dental visit to get familiar with the AR glasses. The augmented reality is an eye goggle that will be connected to the laptop through a wire, then after playing the cartoon that will be selected by the child on the laptop the child will enjoy watching the cartoon movie through the eye goggle.
VR glassesDevice
Children allocated to this group will be managed by Virtual reality glasses, which will be introduced to the child and he will be allowed to choose his favourite cartoon from the same list during the first dental visit to get familiar with the VR glasses. The virtual reality is a head-mounted display, the child will be asked to select his favourite cartoon on a mobile, then the mobile will be inserted in that head-mounted display
| Study group | Role | What they receive |
|---|---|---|
| Augmented Reality | Experimental | Not described Receives: Device: Augmented reality glasses |
| Virtual Reality | Active comparator | Not described Receives: Device: VR glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate (HR) assessment
Heart rate (HR) will be employed as an anxiety indicator, as stress or anxiety can increase it. It will be measured using a pulse oximeter. A brief demonstration using the pulse oximeter will be done, and the patient will be instructed to stay still and not to move his hands a lot in order to obtain accurate readings. The pulse oximeter will be placed on the patient's index finger.
Measured: Baseline to immediately after the procedure (within the same treatment visit).
Anxiety assessment using the Facial Image Scale (FIS)
The FIS comprises one item with a response set of five faces (ranging from a very sad to a very smiley face). Children will be asked to indicate which of the faces they feel most like at that moment, it is a 'state' measure of anxiety that provides an immediate reflection of how the child is feeling.
Measured: Baseline to immediately after the procedure (within the same treatment visit).
Anxiety assessment using Venham's clinical anxiety scale
The Venham's clinical anxiety rating scale will be used to assess the child's dental anxiety at baseline, during and after anesthesia injection and extraction procedure. The assessment will take place by the operator and the independent outcome assessor using the recorded video tapes. This objective measure scores the child's level of anxiety with a correlating behavior description It consists of 6 categories (range from 0 to 5) where 0= relaxed, 1=uneasy, 2= tense, 3= reluctant, 4= interference, 5= out of contact.
Measured: Baseline to immediately after the procedure (within the same treatment visit).
Pain assessment using Wong-Baker FACES pain rating scale
The Wong-Baker FACES Pain Rating Scale will be used to quantify the child's pain experience. This scale ranges from a neutral face, assigned a score of "0," indicating no pain, to a frowning face with a score of "10," representing the highest level of discomfort. The scale will be explained to the child, who will be asked to choose the face that represents how much pain he or she will feel during anesthesia injection and extraction from one of the graphic rating scales by pointing his finger at one of the six faces shown on the chart will be given to him.
Measured: Baseline to immediately after the procedure (within the same treatment visit).
Pain assessment using Face, legs, activity, cry, consolability (FLACC) scale
FLACC behavioral pain assessment scale will be used to assess the child's dental pain during the procedure. This objective measure scores the child's level of pain with a correlating behavior description. It consists of 5 categories (F) face, (L) leg, (A) activity, (C) cry, (C) consolability each is scored from 0 to 2, which results in a total score between zero and ten. The assessment will take place by the operator and the independent outcome assessor, the assessors will assign a score to each category based on the child's response during anesthesia injection and extraction by analysis of the recorded videotapes.
Measured: Baseline to immediately after the procedure (within the same treatment visit).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sara Hazem Mohamed Rabie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sara Hazem Mohamed Rabie, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467395
- Sponsor's protocol ID
- 1189-11/2025
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Augmented Reality on Dental Pain and Anxiety During Primary Molars' Extraction: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07467395
- Acronym / sponsor ID
- 1189-11/2025
- Conditions
- Dental Anxiety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sara Hazem Mohamed RabieUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 12 Mar 2026 (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 aim of this study is to evaluate the impact of using virtual reality glasses compared to augmented reality glasses as distraction methods to reduce the dental anxiety and pain in children during extraction of primary molars.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Augmented Reality | Experimental | Device: Augmented reality glasses |
| Virtual Reality | Active comparator | Device: VR glasses |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Medically free children without visual or auditory impairment (ASA I).
- Children aged 6-8 years.
- Children with Frankl behaviour rating score 3 or 4.
- Children requiring extraction in one of their primary molars.
- Parents who will accept to give their consent and participate in the study
Key exclusion criteria (4 listed)
- Children require emergency dental treatment.
- Children with a history of epilepsy and anxiety disorder.
- Children with previous bad dental experience.
- Allergy to local anaesthetic drugs.
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 glassesAugmented reality glasses will be introduced to the child and he will be allowed to choose his favourite cartoon movie from this list: Rapunzel, Stitch, Ratatouille, Frozen, Minions, Zootopia, and The lion king during the first dental visit to get familiar with the AR glasses. The augmented reality is an eye goggle that will be connected to the laptop through a wire, then after playing the cartoon that will be selected by the child on the laptop the child will enjoy watching the cartoon movie through the eye goggle. | Device | Augmented Reality |
| VR glassesChildren allocated to this group will be managed by Virtual reality glasses, which will be introduced to the child and he will be allowed to choose his favourite cartoon from the same list during the first dental visit to get familiar with the VR glasses. The virtual reality is a head-mounted display, the child will be asked to select his favourite cartoon on a mobile, then the mobile will be inserted in that head-mounted display | Device | Virtual Reality |
Primary outcome
Heart rate (HR) assessment
Time frame: Baseline to immediately after the procedure (within the same treatment visit).
Heart rate (HR) will be employed as an anxiety indicator, as stress or anxiety can increase it. It will be measured using a pulse oximeter. A brief demonstration using the pulse oximeter will be done, and the patient will be instructed to stay still and not to move his hands a lot in order to obtain accurate readings. The pulse oximeter will be placed on the patient's index finger.
Anxiety assessment using the Facial Image Scale (FIS)
Time frame: Baseline to immediately after the procedure (within the same treatment visit).
The FIS comprises one item with a response set of five faces (ranging from a very sad to a very smiley face). Children will be asked to indicate which of the faces they feel most like at that moment, it is a 'state' measure of anxiety that provides an immediate reflection of how the child is feeling.
Anxiety assessment using Venham's clinical anxiety scale
Time frame: Baseline to immediately after the procedure (within the same treatment visit).
The Venham's clinical anxiety rating scale will be used to assess the child's dental anxiety at baseline, during and after anesthesia injection and extraction procedure. The assessment will take place by the operator and the independent outcome assessor using the recorded video tapes. This objective measure scores the child's level of anxiety with a correlating behavior description It consists of 6 categories (range from 0 to 5) where 0= relaxed, 1=uneasy, 2= tense, 3= reluctant, 4= interference, 5= out of contact.
Pain assessment using Wong-Baker FACES pain rating scale
Time frame: Baseline to immediately after the procedure (within the same treatment visit).
The Wong-Baker FACES Pain Rating Scale will be used to quantify the child's pain experience. This scale ranges from a neutral face, assigned a score of "0," indicating no pain, to a frowning face with a score of "10," representing the highest level of discomfort. The scale will be explained to the child, who will be asked to choose the face that represents how much pain he or she will feel during anesthesia injection and extraction from one of the graphic rating scales by pointing his finger at one of the six faces shown on the chart will be given to him.
Pain assessment using Face, legs, activity, cry, consolability (FLACC) scale
Time frame: Baseline to immediately after the procedure (within the same treatment visit).
FLACC behavioral pain assessment scale will be used to assess the child's dental pain during the procedure. This objective measure scores the child's level of pain with a correlating behavior description. It consists of 5 categories (F) face, (L) leg, (A) activity, (C) cry, (C) consolability each is scored from 0 to 2, which results in a total score between zero and ten. The assessment will take place by the operator and the independent outcome assessor, the assessors will assign a score to each category based on the child's response during anesthesia injection and extraction by analysis of the recorded videotapes.
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 12 Mar 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented reality glasses and VR glasses in people with Dental Anxiety, run by Sara Hazem Mohamed Rabie.
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 5 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: opening soon, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Sara H Rabie, BDS (+20 10 67200674, sararabie96@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (HR) assessment (time frame: Baseline to immediately after the procedure (within the same treatment visit).). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2026.