AnaesthesiaNCT06724341
Impact of AR Glasses on Children's Behavior During Dental Nerve Blocks
A study testing Distraction in people with Anaesthesia and Anxiety, run by Damascus University at 1 site in Syria.
Trial summary
The aim of this study is to evaluate the effectiveness of augmented reality glasses in managing pain, anxiety, and behavior in pediatric patients during inferior alveolar nerve block Group A (Control group): inferior alveolar nerve block will be administrated with passive behavior management (displaying animated… Read more about this study
- Who is it for?
- Ages 7 to 9 years
- Conditions the study is for
- Anaesthesia, Anxiety
- What is being tested?
- Distraction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSyria
- Study dates
- 1 Dec 2024to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 7 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged between 7 and 9 years
- Children categorized as having positive or definitely positive behavior on Frankl behavioral scale.
- Children whose dental treatment requires an IANB injection.
- Children with neither previous dental anesthesia experience nor augmented reality experience.
- Children who do not suffer from any neurological, psychological or hearing disorders
Who cannot join
- Children who refuse to put the glasses on.
- Children suffering from acute dental pain.
- Children suffering from auditory or visual disturbances
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of Pediatric Dentistry
Damascus, Syrian Arab Republic, DM20AM19
About this study
Official title: Effect of Active and Passive Augmented Reality Glasses in Behavioral Children Management for Inferior Alveolar Nerve Block - A Randomized Controlled Trial
The aim of this study is to evaluate the effectiveness of augmented reality glasses in managing pain, anxiety, and behavior in pediatric patients during inferior alveolar nerve block
Group A (Control group): inferior alveolar nerve block will be administrated with passive behavior management (displaying animated movies directly on the screen of a mobile device).
Read more
Group B: inferior alveolar nerve block will be administrated with displaying animated movies directly on the screen of a mobile device usage of the augmented reality glasses.
Group C: Application of active behavior management by usage video games on the screen of a mobile device connected to augmented reality glasses before administration of inferior alveolar nerve block.
Group D: An active and passive behavior management will be applied by usage video games before administration of inferior alveolar nerve block and animated movies during administration on the screen of a mobile device connected to augmented reality glasses.
Children in all four groups will be assessed by using a combination of measures:
Venham's picture test (VPT), Pulse Oximeter, Wong-Baker face, observational behavioral scale (using Face - Legs - Activity - Cry - Consolability "FLACC" scale "external evaluator") and general behavior scale (Houpt)
Read the detailed description
This study will evaluate the effectiveness of an augmented reality glasses. Pain, anxiety and general behavior will be evaluated during inferior alveolar nerve block using these behavioral scales, Venham's picture test (VPT), Pulse Oximeter, Wong-Baker face, observational behavioral scale (using Face - Legs - Activity - Cry - Consolability "FLACC" scale "external evaluator") and general behavior scale (Houpt)
VPT scale consists of 8 associated drawings of a child, with each drawing showing a pair of children in two positions: non-anxious (value 0) and anxious (value 1). The child is asked to point to the child that expresses their feelings. The scale ranges from 0 to 8. If a child scores 6 or higher, they will be excluded from the research sample due to negative behavior. Anxiety is measured by monitoring pulse and oxygenation at five different times: before starting, 10 minutes later, when applying topical anesthetic, during the administration of the anesthetic injection, and immediately upon completion of the anesthetic injection. Using the Wong-Baker Faces scale to assess the level of pain after the anesthesia injection by asking the child to indicate the face that best represents their condition. The FLACC scale is a behavioral tool used to assess pain during the administration of an anesthesia injection. The child is recorded on video from before the injection starts until it is finished. The mobile phone is set up to film the child during the injection, and an external observer evaluates the child's behavior. The observer monitors five variables: (Face), (Legs), (Activity), (Cry), and (Consolability). Each variable is scored from 0 to 2, resulting in a total score ranging from 0 to 10. The Houpt scale was used to measure general behavior in children, as it consists of 6 points, starting from grade 1, which is the most violent behavior shown by the child during treatment, to grade 6, which is complete satisfaction with treatment.
- Conditions
- Anaesthesia, Anxiety
- Being tested
- Distraction
- Keywords
- Complementary Therapies, Pediatric Dentistry, Behavior Management, Augmented Reality Glasses
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DistractionBehavioural
Control group: inferior alveolar nerve block will be administrated with passive behavior management (displaying animated movies directly on the screen of a mobile device).
Movies group: inferior alveolar nerve block will be administrated with displaying animated movies directly on the screen of a mobile device usage of the augmented reality glasses.
Video games group: Application of active behavior management by usage video games on the screen of a mobile device connected to augmented reality glasses before administration of inferior alveolar nerve block.
Movies and Video games group: An active and passive behavior management will be applied by usage video games before administration of inferior alveolar nerve block and animated movies during administration on the screen of a mobile device connected to augmented reality glasses.
| Study group | Role | What they receive |
|---|---|---|
| Control group: inferior alveolar nerve block will be administrated with passive behavior management | Experimental | Not described Receives: Behavioral: Distraction |
| Movies group: inferior alveolar nerve block will be administrated with displaying animated movies di | Experimental | Not described Receives: Behavioral: Distraction |
| Video games group: Application of active behavior management by usage video games on the screen of a | Experimental | Not described Receives: Behavioral: Distraction |
| Movies and Video games group: An active and passive behavior management will be applied by usage vid | Experimental | Not described Receives: Behavioral: Distraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety levels
VPT scale
Measured: before starting, ten minutes after stating, and after inferior alveolar nerve block injection
Pain Levels
Wong-Baker FACES
Measured: After administration of inferior alveolar nerve block
Pain Levels
The Face-Legs-Activity-Cry-Consolability (FLACC) scale employing an external evaluator in which all of the body responses will be recorded during the administration of inferior alveolar nerve block. (0 low pain level - 10 highpain level)
Measured: after administration of topical anesthesia, during inferior alveolar nerve block injection, and directly after finishing of the injection]
Anxiety levels
Pulse Oximeter
Measured: before starting, ten minutes after stating, after administration of topical anesthesia, during inferior alveolar nerve block injection, and directly after finishing of the injection
Secondary outcomes (1)
General Behavior Level
Houpt scale consists of 6 points, starting from grade 1, which is the most violent behavior shown by the child during treatment, to grade 6, which is complete satisfaction with treatment
Measured: during administration of inferior alveolar nerve block.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start1 Dec 2024
- Primary completion1 Mar 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnaesthesiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mai Maher Albaal, DDS, Principal investigator, Department of Pediatric Dentistry, Faculty of Dentistry, University of Damascus, Damascus, Syria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06724341
- Sponsor's protocol ID
- UDDS-Pedo-05-2024
- Status last verified
- Nov 2025
- First submitted
- 5 Dec 2024
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zafar S, Zachar JJ. Evaluation of HoloHuman augmented reality application as a novel educational tool in dentistry. Eur J Dent Educ. 2020 May;24(2):259-265. doi: 10.1111/eje.12492. Epub 2020 Jan 20.
PubMed 31899840Yeung AWK, Tosevska A, Klager E, Eibensteiner F, Laxar D, Stoyanov J, Glisic M, Zeiner S, Kulnik ST, Crutzen R, Kimberger O, Kletecka-Pulker M, Atanasov AG, Willschke H. Virtual and Augmented Reality Applications in Medicine: Analysis of the Scientific Literature. J Med Internet Res. 2021 Feb 10;23(2):e25499. doi: 10.2196/25499.
PubMed 33565986Albaal M, Bshara N. Evaluating the use of augmented reality in alleviating anxiety and pain in children during intraoral injection administration: a randomized-controlled trial. Eur Arch Paediatr Dent. 2026 Jun;27(3):739-749. doi: 10.1007/s40368-025-01113-7. Epub 2025 Sep 18.
PubMed 40965811
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Active and Passive Augmented Reality Glasses in Behavioral Children Management for Inferior Alveolar Nerve Block - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06724341
- Acronym / sponsor ID
- UDDS-Pedo-05-2024
- Conditions
- Anaesthesia, Anxiety
- Keywords
- Complementary Therapies, Pediatric Dentistry, Behavior Management, Augmented Reality Glasses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 9 Dec 2024 (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 effectiveness of augmented reality glasses in managing pain, anxiety, and behavior in pediatric patients during inferior alveolar nerve block
Group A (Control group): inferior alveolar nerve block will be administrated with passive behavior management (displaying animated movies directly on the screen of a mobile device).
Group B: inferior alveolar nerve block will be administrated with displaying animated movies directly on the screen of a mobile device usage of the augmented reality glasses.
Group C: Application of active behavior management by usage video games on the screen of a mobile device connected to augmented reality glasses before administration of inferior alveolar nerve block.
Group D: An active and passive behavior management will be applied by usage video games before administration of inferior alveolar nerve block and animated movies during administration on the screen of a mobile device connected to augmented reality glasses.
Children in all four groups will be assessed by using a combination of measures:
Venham's picture test (VPT), Pulse Oximeter, Wong-Baker face, observational behavioral scale (using Face - Legs - Activity - Cry - Consolability "FLACC" scale "external evaluator") and general behavior scale (Houpt)
Detailed description
This study will evaluate the effectiveness of an augmented reality glasses. Pain, anxiety and general behavior will be evaluated during inferior alveolar nerve block using these behavioral scales, Venham's picture test (VPT), Pulse Oximeter, Wong-Baker face, observational behavioral scale (using Face - Legs - Activity - Cry - Consolability "FLACC" scale "external evaluator") and general behavior scale (Houpt)
VPT scale consists of 8 associated drawings of a child, with each drawing showing a pair of children in two positions: non-anxious (value 0) and anxious (value 1). The child is asked to point to the child that expresses their feelings. The scale ranges from 0 to 8. If a child scores 6 or higher, they will be excluded from the research sample due to negative behavior. Anxiety is measured by monitoring pulse and oxygenation at five different times: before starting, 10 minutes later, when applying topical anesthetic, during the administration of the anesthetic injection, and immediately upon completion of the anesthetic injection. Using the Wong-Baker Faces scale to assess the level of pain after the anesthesia injection by asking the child to indicate the face that best represents their condition. The FLACC scale is a behavioral tool used to assess pain during the administration of an anesthesia injection. The child is recorded on video from before the injection starts until it is finished. The mobile phone is set up to film the child during the injection, and an external observer evaluates the child's behavior. The observer monitors five variables: (Face), (Legs), (Activity), (Cry), and (Consolability). Each variable is scored from 0 to 2, resulting in a total score ranging from 0 to 10. The Houpt scale was used to measure general behavior in children, as it consists of 6 points, starting from grade 1, which is the most violent behavior shown by the child during treatment, to grade 6, which is complete satisfaction with treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group: inferior alveolar nerve block will be administrated with passive behavior management | Experimental | Behavioral: Distraction |
| Movies group: inferior alveolar nerve block will be administrated with displaying animated movies di | Experimental | Behavioral: Distraction |
| Video games group: Application of active behavior management by usage video games on the screen of a | Experimental | Behavioral: Distraction |
| Movies and Video games group: An active and passive behavior management will be applied by usage vid | Experimental | Behavioral: Distraction |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged between 7 and 9 years
- Children categorized as having positive or definitely positive behavior on Frankl behavioral scale.
- Children whose dental treatment requires an IANB injection.
- Children with neither previous dental anesthesia experience nor augmented reality experience.
- Children who do not suffer from any neurological, psychological or hearing disorders
Key exclusion criteria (3 listed)
- Children who refuse to put the glasses on.
- Children suffering from acute dental pain.
- Children suffering from auditory or visual disturbances
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 |
|---|---|---|
| DistractionControl group: inferior alveolar nerve block will be administrated with passive behavior management (displaying animated movies directly on the screen of a mobile device). Movies group: inferior alveolar nerve block will be administrated with displaying animated movies directly on the screen of a mobile device usage of the augmented reality glasses. Video games group: Application of active behavior management by usage video games on the screen of a mobile device connected to augmented reality glasses before administration of inferior alveolar nerve block. Movies and Video games group: An active and passive behavior management will be applied by usage video games before administration of inferior alveolar nerve block and animated movies during administration on the screen of a mobile device connected to augmented reality glasses. | Behavioural | Control group: inferior alveolar nerve block will be administrated with passive behavior management, Movies and Video games group: An active and passive behavior management will be applied by usage vid, Movies group: inferior alveolar nerve block will be administrated with displaying animated movies di, Video games group: Application of active behavior management by usage video games on the screen of a |
Primary outcome
Anxiety levels
Time frame: before starting, ten minutes after stating, and after inferior alveolar nerve block injection
VPT scale
Pain Levels
Time frame: After administration of inferior alveolar nerve block
Wong-Baker FACES
Pain Levels
Time frame: after administration of topical anesthesia, during inferior alveolar nerve block injection, and directly after finishing of the injection]
The Face-Legs-Activity-Cry-Consolability (FLACC) scale employing an external evaluator in which all of the body responses will be recorded during the administration of inferior alveolar nerve block. (0 low pain level - 10 highpain level)
Anxiety levels
Time frame: before starting, ten minutes after stating, after administration of topical anesthesia, during inferior alveolar nerve block injection, and directly after finishing of the injection
Pulse Oximeter
1 secondary outcome
General Behavior Level
Time frame: during administration of inferior alveolar nerve block.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Background: PubMed 31899840Zafar S, Zachar JJ. Evaluation of HoloHuman augmented reality application as a novel educational tool in dentistry. Eur J Dent Educ. 2020 May;24(2):259-265. doi: 10.1111/eje.12492. Epub 2020 Jan 20.
- Background: PubMed 33565986Yeung AWK, Tosevska A, Klager E, Eibensteiner F, Laxar D, Stoyanov J, Glisic M, Zeiner S, Kulnik ST, Crutzen R, Kimberger O, Kletecka-Pulker M, Atanasov AG, Willschke H. Virtual and Augmented Reality Applications in Medicine: Analysis of the Scientific Literature. J Med Internet Res. 2021 Feb 10;23(2):e25499. doi: 10.2196/25499.
- Derived from this study: PubMed 40965811Albaal M, Bshara N. Evaluating the use of augmented reality in alleviating anxiety and pain in children during intraoral injection administration: a randomized-controlled trial. Eur Arch Paediatr Dent. 2026 Jun;27(3):739-749. doi: 10.1007/s40368-025-01113-7. Epub 2025 Sep 18.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Mai Maher Albaal, DDS principal investigator
Department of Pediatric Dentistry, Faculty of Dentistry, University of Damascus, Damascus, Syria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distraction in people with Anaesthesia and Anxiety, run by Damascus University at 1 site in Syria.
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 3 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: finished, as of the sponsor's last update on 17 Nov 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 Syria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety levels (time frame: before starting, ten minutes after stating, and after inferior alveolar nerve block injection). The study lists 4 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 NCT06724341, which also lists 3 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 17 Nov 2025.