Dental AnxietyNCT06970613
Effects Of Two Different Methods In Reducing Dental Anxiety In Children
A study testing Watching cartoons and Robot cat in people with Dental Anxiety, run by Melis AKYILDIZ at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to determine the effects of two different methods in reducing dental anxiety in children. The secondary aim of our research was to determine the levels of dental anxiety in children and the factors that may be related to it. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Watching cartoons and Robot cat
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jun 2022to 1 Jun 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Between the ages of 6-10
- Systemically and mentally healthy
- Not allergic to local anesthetics
- Not afraid of pets
- In need of restorative treatment
- No spontaneous pain complaints
- Parents who agreed to participate in the study
Who cannot join
- Children with previous complaints of severe spontaneous pain
- Teeth requiring endodontic treatment
- Children who are definitely negative according to the Frankl behavior scale
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aydin Adnan Menderes University
Aydin, Efeler, 09100
About this study
Official title: Effects Of Two Different Methods In Reducing Dental Anxiety In Children: An Experimental Study
This study aimed to determine the effects of two different methods in reducing dental anxiety in children. The secondary aim of our research was to determine the levels of dental anxiety in children and the factors that may be related to it.
Read the detailed description
Anxiety is defined as an emotional state that comes before encountering a feared situation or object. Anxiety can also be seen as a coping mechanism that a person develops to cope with stress, existing before the feared situation actually occurs. Many factors such as physical, cognitive, psychosocial, and economic factors can play a role in the development of anxiety, as well as treatments and interventions related to oral and dental health can be a source of anxiety for the individual. Negative and strong feelings related to any type of dental procedure are called dental anxiety. According to studies, the prevalence of dental anxiety is estimated to vary between 3% and 43% worldwide. Dental anxiety/fear is a very common problem worldwide, observed frequently in children as well as in the elderly, adults, and adolescents.
The prevalence of dental anxiety in children is estimated to be between 5% and 20%. Dental anxiety in children may be due to internal factors such as age and temperament, as well as external factors related to the family such as anxiety and socio-economic status, and external dental factors such as dental-related conditions and medical experiences. In addition, the first dental visit, painful and disturbing stimuli that the child may encounter (such as the instruments used, the waiting room, the doctor's appearance, sounds), the doctor's approach, and the culture in which the child was born and raised are also important factors for dental anxiety.
In order to increase the success of dental treatment in children, determining the level of dental anxiety is important for the application of appropriate techniques. In order to manage dental anxiety in a healthy way and increase the child's compliance with treatment, determining dental anxiety, applying management approaches according to the type and level of dental anxiety, informing children appropriate to their age before any medical interventions and procedures to be performed regarding oral and dental health and using appropriate methods will contribute to controlling the child's worries and fears. In this way, dental anxiety is reduced; It can be effective in reducing the patient's avoidance of dental visits and entering a vicious cycle of dental anxiety, tooth decay/loss, poor oral hygiene, oral and dental health problems that may occur in adulthood and related eating difficulties, pain, avoidance of socialization behaviors and increasing children's compliance with treatment, as well as allowing dentists to work with less stress and minimizing possible time losses. For this reason, recognizing and resolving dental anxiety while still in childhood is an extremely important issue for the success of treatment.
When studies conducted to reduce dental anxiety in children were examined; it was found that distraction through videotapes reduced dental anxiety and fear, and at the same time, it would make working with this patient group, which is more difficult for dentists, more comfortable and would reduce the time spent, while in a study using humanoid robots, a newer technology, it was concluded that robots also helped children cope with dental anxiety and stress, and in another study conducted in a similar way to reduce dental fear in children; it was concluded that informing children by playing with play dough from the dentist's set before the procedure to be performed in dental applications reduced dental anxiety, and that the dental anxiety of the children in the control group who did not play with play dough was higher than before the procedure. Another study has shown that distracting children's attention by playing with toys in the waiting room before a dental procedure can also be effective in reducing dental anxiety.
In a study conducted with adults, it was stated that dog-assisted therapy and dental anxiety were related, that there was a decrease in perceived discomfort during the intervention and that there was an improvement in the patient's evaluation of the experience. Similarly, it has been shown that animal-assisted treatments have positive effects on dental anxiety in children. For this purpose, professional dogs that have received therapy support training are used. However, it has been emphasized that animal-assisted dental treatments can be risky for both the dog and the dental staff due to clinical hygiene conditions and can be applied if the necessary precautions are taken. Today, social robots have been developed thanks to advanced technologies and studies have shown that they are beneficial for individuals who feel the need for emotional support. In this study, it was aimed to investigate the effect of robot cats, which are both suitable for use in hygienic conditions and developed for those who need emotional support, on dental anxiety in children.
- Conditions
- Dental Anxiety
- Being tested
- Watching cartoons, Robot cat
- Keywords
- Pediatric Dental Anxiety, Dental anxiety, Pet Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Watching cartoonsBehavioural
While watching the cartoons, local anesthesia will be applied and restorative treatments will be completed.
Robot catBehavioural
Local anesthesia will be applied with the robot cat in their lap during the treatment and their restorative treatments will be completed.
| Study group | Role | What they receive |
|---|---|---|
| Watching cartoons | Experimental | Non-pharmacological behavioral guidance techniques and cartoons will be watched as a distraction method. Receives: Behavioral: Watching cartoons |
| Robot Cat | Experimental | Non-pharmacological behavioral guidance techniques and a robot cat will be used as a distraction method. Receives: Behavioral: Robot cat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Child Dental Anxiety Scale (MCDASf)
It consists of eight questions, each addressing a specific dental procedure or situation. For each question, children are asked to rate their anxiety using a set of five facial expressions, ranging from relaxed/happy to very worried/scared.
Each face corresponds to a numerical score from 1 to 5:1=Not worried at all,2=A little worried,3=Quite worried,4=Very worried,5=Really worried Children select the face that best matches their feelings for each question. The total score is calculated by summing the scores for all eight items, giving a possible range from 8 to 40:A total score of 8 indicates no dental anxiety. A total score of 40 indicates extreme dental anxiety.
Measured: Baseline (T1)
Modified Child Dental Anxiety Scale (MCDASf)
It consists of eight questions, each addressing a specific dental procedure or situation. For each question, children are asked to rate their anxiety using a set of five facial expressions, ranging from relaxed/happy to very worried/scared.
Each face corresponds to a numerical score from 1 to 5:1=Not worried at all,2=A little worried,3=Quite worried,4=Very worried,5=Really worried Children select the face that best matches their feelings for each question. The total score is calculated by summing the scores for all eight items, giving a possible range from 8 to 40:A total score of 8 indicates no dental anxiety. A total score of 40 indicates extreme dental anxiety.
Measured: Immediately after the local anaesthesiat (T3)
Secondary outcomes (4)
Face, legs, activity, cry, consobility (FLACC) test
Face, legs, activity, cry, consobility (FLACC) test is a behavior rating scale. The Turkish language validity of the pain assessment scale developed by Merkel and colleagues in 1997 and used in the hospital assessment of acute process-related and postoperative pain was done by Şenayli et al. (2006). The measurement is made by evaluating five behavioral categories (facial expression, leg movements, activity, crying, comfortability) in children. Each item is scored between 0 and 2. A score of 0 indicates that the patient is comfortable; 1-3 indicates mild pain; 4-6 indicates moderate pain, and 7-10 indicates severe pain.
Measured: During the local anaesthesia (T2)
Venham Picture Test
The Venham Picture Test is one of the visual self-report methods used to assess children's anxiety levels, particularly in clinical settings such as dentistry. It consists of eight cards, each displaying two cartoon figures side by side-one depicting a non-worried (relaxed or happy) child and the other depicting a worried (anxious or distressed) child. Each card is numbered and presented in a fixed order.
Children are asked to look at each pair and select the figure that best represents how they feel at that moment. For each card, if the child chooses the worried figure, they receive a score of 1; if they choose the non-worried figure, they receive a score of 0.The lowest possible total score is 0, indicating no anxiety, where the child consistently chooses the non-worried figures.The highest possible total score is 8, indicating high anxiety, where the child selects the worried figure on all eight cards.
Measured: Baseline (T1)
Venham Picture Test
The Venham Picture Test is one of the visual self-report methods used to assess children's anxiety levels, particularly in clinical settings such as dentistry. It consists of eight cards, each displaying two cartoon figures side by side-one depicting a non-worried (relaxed or happy) child and the other depicting a worried (anxious or distressed) child. Each card is numbered and presented in a fixed order.
Children are asked to look at each pair and select the figure that best represents how they feel at that moment. For each card, if the child chooses the worried figure, they receive a score of 1; if they choose the non-worried figure, they receive a score of 0.The lowest possible total score is 0, indicating no anxiety, where the child consistently chooses the non-worried figures.The highest possible total score is 8, indicating high anxiety, where the child selects the worried figure on all eight cards.
Measured: Immediately after the local anaesthesiat (T3)
Wong-Baker Faces pain rating scale
This scale is a pain measurement scale developed for the elderly, children and patient populations with whom communication is difficult, including facial images expressing various emotions. It is frequently preferred, especially for children under the age of six and in the preschool period, due to its repeatability and ease of use. The Wong-Baker Face Scale consists of six cartoon faces, ranked from very happy to very unhappy. Children are asked which shape they find closest to their own feelings and are asked to mark it. The total score according to the scale is calculated by giving 0 to the happiest face and 5 to the unhappiest face.
Measured: Immediately after the local anaesthesiat (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start17 Jun 2022
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is an experimental, controlled randomized study.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melis AKYILDIZ
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Melis AKYILDIZ, Aydin Adnan Menderes University
- Investigators
- Rahsan Cevik Akyil, Prof. Dr., Study director, Aydin Adnan Menderes UniversityBahar Melis AKYILDIZ, Phd, Principal investigator, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970613
- Sponsor's protocol ID
- ADU-DHF-BNSAydogan-01
- Status last verified
- Jun 2025
- First submitted
- 20 Apr 2025
- Last updated
- 25 Jun 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 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Two Different Methods In Reducing Dental Anxiety In Children: An Experimental Study
- ClinicalTrials.gov ID
- NCT06970613
- Acronym / sponsor ID
- ADU-DHF-BNSAydogan-01
- Conditions
- Dental Anxiety
- Keywords
- Pediatric Dental Anxiety, Dental anxiety, Pet Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Melis AKYILDIZUniversity, hospital or other
- Study start
- 17 Jun 2022 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 14 May 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.
This study aimed to determine the effects of two different methods in reducing dental anxiety in children. The secondary aim of our research was to determine the levels of dental anxiety in children and the factors that may be related to it.
Detailed description
Anxiety is defined as an emotional state that comes before encountering a feared situation or object. Anxiety can also be seen as a coping mechanism that a person develops to cope with stress, existing before the feared situation actually occurs. Many factors such as physical, cognitive, psychosocial, and economic factors can play a role in the development of anxiety, as well as treatments and interventions related to oral and dental health can be a source of anxiety for the individual. Negative and strong feelings related to any type of dental procedure are called dental anxiety. According to studies, the prevalence of dental anxiety is estimated to vary between 3% and 43% worldwide. Dental anxiety/fear is a very common problem worldwide, observed frequently in children as well as in the elderly, adults, and adolescents.
The prevalence of dental anxiety in children is estimated to be between 5% and 20%. Dental anxiety in children may be due to internal factors such as age and temperament, as well as external factors related to the family such as anxiety and socio-economic status, and external dental factors such as dental-related conditions and medical experiences. In addition, the first dental visit, painful and disturbing stimuli that the child may encounter (such as the instruments used, the waiting room, the doctor's appearance, sounds), the doctor's approach, and the culture in which the child was born and raised are also important factors for dental anxiety.
In order to increase the success of dental treatment in children, determining the level of dental anxiety is important for the application of appropriate techniques. In order to manage dental anxiety in a healthy way and increase the child's compliance with treatment, determining dental anxiety, applying management approaches according to the type and level of dental anxiety, informing children appropriate to their age before any medical interventions and procedures to be performed regarding oral and dental health and using appropriate methods will contribute to controlling the child's worries and fears. In this way, dental anxiety is reduced; It can be effective in reducing the patient's avoidance of dental visits and entering a vicious cycle of dental anxiety, tooth decay/loss, poor oral hygiene, oral and dental health problems that may occur in adulthood and related eating difficulties, pain, avoidance of socialization behaviors and increasing children's compliance with treatment, as well as allowing dentists to work with less stress and minimizing possible time losses. For this reason, recognizing and resolving dental anxiety while still in childhood is an extremely important issue for the success of treatment.
When studies conducted to reduce dental anxiety in children were examined; it was found that distraction through videotapes reduced dental anxiety and fear, and at the same time, it would make working with this patient group, which is more difficult for dentists, more comfortable and would reduce the time spent, while in a study using humanoid robots, a newer technology, it was concluded that robots also helped children cope with dental anxiety and stress, and in another study conducted in a similar way to reduce dental fear in children; it was concluded that informing children by playing with play dough from the dentist's set before the procedure to be performed in dental applications reduced dental anxiety, and that the dental anxiety of the children in the control group who did not play with play dough was higher than before the procedure. Another study has shown that distracting children's attention by playing with toys in the waiting room before a dental procedure can also be effective in reducing dental anxiety.
In a study conducted with adults, it was stated that dog-assisted therapy and dental anxiety were related, that there was a decrease in perceived discomfort during the intervention and that there was an improvement in the patient's evaluation of the experience. Similarly, it has been shown that animal-assisted treatments have positive effects on dental anxiety in children. For this purpose, professional dogs that have received therapy support training are used. However, it has been emphasized that animal-assisted dental treatments can be risky for both the dog and the dental staff due to clinical hygiene conditions and can be applied if the necessary precautions are taken. Today, social robots have been developed thanks to advanced technologies and studies have shown that they are beneficial for individuals who feel the need for emotional support. In this study, it was aimed to investigate the effect of robot cats, which are both suitable for use in hygienic conditions and developed for those who need emotional support, on dental anxiety in children.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is an experimental, controlled randomized study.
| Arm | Type | Receives |
|---|---|---|
| Watching cartoons | Experimental | Behavioral: Watching cartoonsNon-pharmacological behavioral guidance techniques and cartoons will be watched as a distraction method. |
| Robot Cat | Experimental | Behavioral: Robot catNon-pharmacological behavioral guidance techniques and a robot cat will be used as a distraction method. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Between the ages of 6-10
- Systemically and mentally healthy
- Not allergic to local anesthetics
- Not afraid of pets
- In need of restorative treatment
Key exclusion criteria (3 listed)
- Children with previous complaints of severe spontaneous pain
- Teeth requiring endodontic treatment
- Children who are definitely negative according to the Frankl behavior scale
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 |
|---|---|---|
| Watching cartoonsWhile watching the cartoons, local anesthesia will be applied and restorative treatments will be completed. | Behavioural | Watching cartoons |
| Robot catLocal anesthesia will be applied with the robot cat in their lap during the treatment and their restorative treatments will be completed. | Behavioural | Robot Cat |
Primary outcome
Modified Child Dental Anxiety Scale (MCDASf)
Time frame: Baseline (T1)
It consists of eight questions, each addressing a specific dental procedure or situation. For each question, children are asked to rate their anxiety using a set of five facial expressions, ranging from relaxed/happy to very worried/scared. Each face corresponds to a numerical score from 1 to 5:1=Not worried at all,2=A little worried,3=Quite worried,4=Very worried,5=Really worried Children select the face that best matches their feelings for each question. The total score is calculated by summing the scores for all eight items, giving a possible range from 8 to 40:A total score of 8 indicates no dental anxiety. A total score of 40 indicates extreme dental anxiety.
Modified Child Dental Anxiety Scale (MCDASf)
Time frame: Immediately after the local anaesthesiat (T3)
It consists of eight questions, each addressing a specific dental procedure or situation. For each question, children are asked to rate their anxiety using a set of five facial expressions, ranging from relaxed/happy to very worried/scared. Each face corresponds to a numerical score from 1 to 5:1=Not worried at all,2=A little worried,3=Quite worried,4=Very worried,5=Really worried Children select the face that best matches their feelings for each question. The total score is calculated by summing the scores for all eight items, giving a possible range from 8 to 40:A total score of 8 indicates no dental anxiety. A total score of 40 indicates extreme dental anxiety.
4 secondary outcomes
Face, legs, activity, cry, consobility (FLACC) test
Time frame: During the local anaesthesia (T2)
Venham Picture Test
Time frame: Baseline (T1)
Venham Picture Test
Time frame: Immediately after the local anaesthesiat (T3)
Wong-Baker Faces pain rating scale
Time frame: Immediately after the local anaesthesiat (T3)
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 25 Jun 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.
Rahsan Cevik Akyil, Prof. Dr. study director
Aydin Adnan Menderes University
Bahar Melis AKYILDIZ, Phd principal investigator
Aydin Adnan Menderes 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 Watching cartoons and Robot cat in people with Dental Anxiety, run by Melis AKYILDIZ 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 7 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 25 Jun 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?
Modified Child Dental Anxiety Scale (MCDASf) (time frame: Baseline (T1)). 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?
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 25 Jun 2025.