AnxietyNCT06530654
Effect of Augmented Reality on Dental Anxiety and Pain Perception in Children
A study testing Distraction by dentist, Distraction by cartoon movie and AG-active distraction group in people with Anxiety and Pain, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to reduce dental anxiety in children by using augmented reality (AG) with a special content and innovative interactive methods, to determine the level of stress experienced by patients during dental treatment and to ease the workload of dentists. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- What is being tested?
- Distraction by dentist, Distraction by cartoon movie and AG-active distraction group
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 30 Jul 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 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Systemically and mentally healthy patients without any previous dental treatment experience,
- Children who required pulpotomy in lower primary molars under local anaesthesia.
Who cannot join
- Systemic disease,
- Mental and cognitive disorders, visual and auditory disabilities.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Faculty of Dentistry, Department of Pedodontics
Istanbul
About this study
Official title: Augmented Reality as a Distraction Technique in Paediatric Dental Care, Assessment of Resulting Effects on Patient Anxiety, Pain and Behaviour
The aim of this study is to reduce dental anxiety in children by using augmented reality (AG) with a special content and innovative interactive methods, to determine the level of stress experienced by patients during dental treatment and to ease the workload of dentists.
The effectiveness of augmented reality system is tested by comparing evaluation metrics of three groups of children. In the first group, the dentist carries out the treatment alone. In the second group participants watch cartoons on a screen mounted dental unit during the treatment. In the third group, dental treatment is carried out with AG. In the course of these experiments, the effects of AG on dental treatment (vital pulpotomy and dental filling) that require local anesthesia is examined in order to measure the effects of AG on the level of stress on dental treatment.
Corresponding measures are; (1) the child's anxiety; (2) the child's pain perception during local anaesthesia and treatment; (3) the child's cooperation and general behaviour. The outcomes of the child's anxiety, pain perception, cooperation and general behaviour for three groups were evaluated by statistical analysis.
Read the detailed description
Dental anxiety can be seen in all age groups with frequency varying between 10-36% and can have negative impacts on patients and doctors. It may interrupt treatment or cause patients to avoid treatment altogether, potentially resulting in an increase in oral and dental health problems. Studies show it's possible to prevent dental anxiety at younger ages. Among basic behavior management techniques, dentists frequently depend on the distraction method to relieve patient anxiety. Literature suggests contemporary technological solutions are prominently used for distracting patients during or before dental procedures.
Literature shows robot-guided dental treatments can reduce anxiety. However, the high cost of robots, need for additional staff to direct the robot, and decrease in the overall interaction quality due to noise limit their use in clinical environments. Other studies suggest virtual reality (VR) for pediatric dental anxiety. Although VR has been successful in alleviating dental anxiety, a number of factors make it less preferable. Having to wear bulky glasses for interaction may cause discomfort to the patient. Physicians may find these devices impractical as their dimensions restrict the doctor's working area. Furthermore, completely isolating the patient from the clinic environment may cause additional anxiety. This study proposes an augmented reality (AR) approach to ease dental anxiety in pediatric patients. Using AR as a distraction technique, patients can still interact with virtual entities as if they're part of the real world, without having to be completely isolated from the clinical environment.
This study aims to reduce dental anxiety and pain perception in children by using an AR application both before and during treatment. Content especially prepared for dental treatment will be presented to patients using an innovative mobile AR interaction system. Patients will interact with the AR system in three stages. First, before treatment, the application will inform patients about equipment used during treatment. Patients will be able to interact with informative and entertaining virtual content superimposed on the real environment with avatars guiding them. The content and interaction are expected to relieve dental anxiety and increase the success rates in pediatric dental treatments. Second, the AR screen will act as a virtual stage mounted in a position that the patient can see comfortably during treatment. The child will be able to relate to virtual entities without being isolated from the environment, unlike in virtual reality solutions. Third, a rich and immersive interaction experience will be provided following treatment within the framework of gamification and personalization principles.
The effectiveness of the AR system will be evaluated by cross comparison with two other groups of patients. The control group will receive traditional dental treatment. The cartoon group will watch a cartoon movie during treatment. For the purposes of this study, tooth extraction and filling procedures that require local anesthesia will be applied to all three groups. Salivary cortisol, α-Amylase and Chromogranin (CHGA) levels will be compared to pulse measurements and evaluated with psychometric scales to determine the effects of AR on dental anxiety levels of pediatric patients.
It is expected that the stress and workload experienced by dentists will be reduced, and the child's dental treatment session will be made more comfortable for the dentist, patient and parent. Additionally, reduction of the need for high-cost equipment and qualified teams required within the scope of advanced behavior guidance techniques used to complete dental treatments in children whose dental anxiety and fear cannot be eliminated is one of the significant impacts of this study. This study is the first study in the world in which an AR system will be utilized in the field of dental treatment in order to reduce dental anxiety in children.
- Being tested
- Distraction by dentist, Distraction by cartoon movie, AG-active distraction group
- Keywords
- Pain Management, Anxiety, Child, Application Software Development, Augmented Reality, Human Computer Interaction
- Medical subject headings
- Anxiety Disorders, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distraction by dentistBehavioural
Dental treatment is carried out with tell-show-do technique as a behavioural guidance technique.
Distraction by cartoon movieBehavioural
Dental treatment is carried out with showing cartoon movie as a passive distraction during the treatment.
AG-active distraction groupBehavioural
The active distraction group is treated and interacting with the designed application
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment group | Active comparator | Basic behavior orientation techniques (tell-show-do) is applied by the dentist during the treatment. Receives: Behavioral: Distraction by dentist |
| Cartoon movie- passive distraction group | Experimental | Children watch cartoons on a screen mounted dental unit during the treatment. Receives: Behavioral: Distraction by cartoon movie |
| AG-active distraction group | Experimental | A tablet will be used for AG notation. How to use AG will be shown to the pediatric patient just before the treatment. Since it is aimed to keep the verbal communication of the dentist with the child at the lowest level, a similar "tell-show-do" technique used in the control group will be digitally simulated on the AG. The instruments that the dentist will use during the procedure will be promoted on AG using animated content. Receives: Behavioral: AG-active distraction group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child's anxiety assessment (objective)
In order to determine the stress levels of the children included in the study, cortisol, α-Amylase and CHGA levels in saliva will be measured
Measured: 1 year
Secondary outcomes (4)
Child's anxiety assessment (objective)
Heart rate is used to determine the anxiety levels of all treated children at certain critical moments of the treatment being. Significant differences in heart rate is compared between groups.
Measured: 1 year
Child's anxiety assessment (subjective)
Scores on the Modified Child Dental Anxiety Scale, MCDAS(f) scale may range from 8 to 40, with scores below 19 indicating absence of state anxiety, scores higher than 19 indicating the pres- ence of state anxiety and scores higher than 31, in- dicating severe phobic disorder
Measured: 1 year
Child's pain assessment (subjective)
The Wong-Baker Faces Pain Rating Scale is a method for someone to self-assess and effectively communicate the severity of pain they may be experiencing. The scale contains a series of six faces ranging from a happy face at 0 to indicate "no hurt" to a crying face at 10 to indicate "hurts worst.
Measured: 1 year
Child's behaviour assessment (subjective) Child's pain assessment (subjective)
According to the The Frankl Behavior Rating Scale, the child's attitude towards treatment is divided into 4 groups and scored between 1-4 meaning: 1 point absolutely negative (child refuses treatment, strong fear and crying), 2 points negative (reluctant to accept treatment), 3 points positive (child accepts treatment, but is cowardly and timid) 4 points absolutely positive (compatible with pediatric dentist).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start1 Jul 2024
- Primary completion2 Jun 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Technical University
- Responsible party
- Principal investigator, Yelda Kasımoğlu, Istanbul University
- Investigators
- Elif Tuna Ince, Prof.Dr., Study director, Department of Pedodontics, Faculty of Dentistry, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530654
- Sponsor's protocol ID
- 123S793
- Status last verified
- Aug 2025
- First submitted
- 26 Jul 2024
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmented Reality as a Distraction Technique in Paediatric Dental Care, Assessment of Resulting Effects on Patient Anxiety, Pain and Behaviour
- ClinicalTrials.gov ID
- NCT06530654
- Acronym / sponsor ID
- 123S793
- Keywords
- Pain Management, Anxiety, Child, Application Software Development, Augmented Reality, Human Computer Interaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Collaborators
- Istanbul Technical University
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 2 Jun 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 31 Jul 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 reduce dental anxiety in children by using augmented reality (AG) with a special content and innovative interactive methods, to determine the level of stress experienced by patients during dental treatment and to ease the workload of dentists.
The effectiveness of augmented reality system is tested by comparing evaluation metrics of three groups of children. In the first group, the dentist carries out the treatment alone. In the second group participants watch cartoons on a screen mounted dental unit during the treatment. In the third group, dental treatment is carried out with AG. In the course of these experiments, the effects of AG on dental treatment (vital pulpotomy and dental filling) that require local anesthesia is examined in order to measure the effects of AG on the level of stress on dental treatment.
Corresponding measures are; (1) the child's anxiety; (2) the child's pain perception during local anaesthesia and treatment; (3) the child's cooperation and general behaviour. The outcomes of the child's anxiety, pain perception, cooperation and general behaviour for three groups were evaluated by statistical analysis.
Detailed description
Dental anxiety can be seen in all age groups with frequency varying between 10-36% and can have negative impacts on patients and doctors. It may interrupt treatment or cause patients to avoid treatment altogether, potentially resulting in an increase in oral and dental health problems. Studies show it's possible to prevent dental anxiety at younger ages. Among basic behavior management techniques, dentists frequently depend on the distraction method to relieve patient anxiety. Literature suggests contemporary technological solutions are prominently used for distracting patients during or before dental procedures.
Literature shows robot-guided dental treatments can reduce anxiety. However, the high cost of robots, need for additional staff to direct the robot, and decrease in the overall interaction quality due to noise limit their use in clinical environments. Other studies suggest virtual reality (VR) for pediatric dental anxiety. Although VR has been successful in alleviating dental anxiety, a number of factors make it less preferable. Having to wear bulky glasses for interaction may cause discomfort to the patient. Physicians may find these devices impractical as their dimensions restrict the doctor's working area. Furthermore, completely isolating the patient from the clinic environment may cause additional anxiety. This study proposes an augmented reality (AR) approach to ease dental anxiety in pediatric patients. Using AR as a distraction technique, patients can still interact with virtual entities as if they're part of the real world, without having to be completely isolated from the clinical environment.
This study aims to reduce dental anxiety and pain perception in children by using an AR application both before and during treatment. Content especially prepared for dental treatment will be presented to patients using an innovative mobile AR interaction system. Patients will interact with the AR system in three stages. First, before treatment, the application will inform patients about equipment used during treatment. Patients will be able to interact with informative and entertaining virtual content superimposed on the real environment with avatars guiding them. The content and interaction are expected to relieve dental anxiety and increase the success rates in pediatric dental treatments. Second, the AR screen will act as a virtual stage mounted in a position that the patient can see comfortably during treatment. The child will be able to relate to virtual entities without being isolated from the environment, unlike in virtual reality solutions. Third, a rich and immersive interaction experience will be provided following treatment within the framework of gamification and personalization principles.
The effectiveness of the AR system will be evaluated by cross comparison with two other groups of patients. The control group will receive traditional dental treatment. The cartoon group will watch a cartoon movie during treatment. For the purposes of this study, tooth extraction and filling procedures that require local anesthesia will be applied to all three groups. Salivary cortisol, α-Amylase and Chromogranin (CHGA) levels will be compared to pulse measurements and evaluated with psychometric scales to determine the effects of AR on dental anxiety levels of pediatric patients.
It is expected that the stress and workload experienced by dentists will be reduced, and the child's dental treatment session will be made more comfortable for the dentist, patient and parent. Additionally, reduction of the need for high-cost equipment and qualified teams required within the scope of advanced behavior guidance techniques used to complete dental treatments in children whose dental anxiety and fear cannot be eliminated is one of the significant impacts of this study. This study is the first study in the world in which an AR system will be utilized in the field of dental treatment in order to reduce dental anxiety in children.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard treatment group | Active comparator | Behavioral: Distraction by dentistBasic behavior orientation techniques (tell-show-do) is applied by the dentist during the treatment. |
| Cartoon movie- passive distraction group | Experimental | Behavioral: Distraction by cartoon movieChildren watch cartoons on a screen mounted dental unit during the treatment. |
| AG-active distraction group | Experimental | Behavioral: AG-active distraction groupA tablet will be used for AG notation. How to use AG will be shown to the pediatric patient just before the treatment. Since it is aimed to keep the verbal communication of the dentist with the child at the lowest level, a similar "tell-show-do" technique used in the control group will be digitally simulated on the AG. The instruments that the dentist will use during the procedure will be promoted on AG using animated content. |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Systemically and mentally healthy patients without any previous dental treatment experience,
- Children who required pulpotomy in lower primary molars under local anaesthesia.
Key exclusion criteria (2 listed)
- Systemic disease,
- Mental and cognitive disorders, visual and auditory disabilities.
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 |
|---|---|---|
| Distraction by dentistDental treatment is carried out with tell-show-do technique as a behavioural guidance technique. | Behavioural | Standard treatment group |
| Distraction by cartoon movieDental treatment is carried out with showing cartoon movie as a passive distraction during the treatment. | Behavioural | Cartoon movie- passive distraction group |
| AG-active distraction groupThe active distraction group is treated and interacting with the designed application | Behavioural | AG-active distraction group |
Primary outcome
Child's anxiety assessment (objective)
Time frame: 1 year
In order to determine the stress levels of the children included in the study, cortisol, α-Amylase and CHGA levels in saliva will be measured
4 secondary outcomes
Child's anxiety assessment (objective)
Time frame: 1 year
Child's anxiety assessment (subjective)
Time frame: 1 year
Child's pain assessment (subjective)
Time frame: 1 year
Child's behaviour assessment (subjective) Child's pain assessment (subjective)
Time frame: 1 year
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 7 Aug 2025.
- 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.
Elif Tuna Ince, Prof.Dr. study director
Department of Pedodontics, Faculty of Dentistry, Istanbul 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 Distraction by dentist, Distraction by cartoon movie and AG-active distraction group in people with Anxiety and Pain, run by Istanbul University at 1 site in Turkey (Türkiye).
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 2 inclusion and 2 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 7 Aug 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 Turkey (Türkiye). 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?
Child's anxiety assessment (objective) (time frame: 1 year). 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 7 Aug 2025.