Animal-Human BondingTAADANCT07439289
Turtle-Assisted Animal Interaction on Dental Anxiety and Physiological Parameters in Children
A study testing experimental group in people with Animal-Human Bonding and Dental Anxiety, run by Igdir University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to measure the effect of a structured AAT session with a turtle present on dental anxiety and behavioral compliance in children during routine procedures that do not require local anesthesia in a pediatric dental clinic. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Animal-Human Bonding, Dental Anxiety, Pediatric Disease
- What is being tested?
- experimental group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to 1 Oct 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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 6-10 years
- Children with ASA I-II general health status
- Children who have obtained written parental consent + an age-appropriate informed consent form
- Children undergoing non-invasive procedures that do not require local anesthesia, such as dental examinations, fissure sealant or fluoride application. • Children who can understand Turkish instructions (for scale application).
Who cannot join
- • Children with animal phobia / intense fear of turtles (as stated by the child or parent). • Children with immunosuppression or a history of severe allergic diseases. • Children with a dental plan requiring sedation/GA within the last month (due to intense anxiety or systemic illness).
- Children with an active infectious disease / a condition requiring isolation. • Children for whom a physician has deemed contact with animals inadvisable. • Children who have been included in a similar behavioral/anxiety intervention program during the same period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Igdır University
Iğdır, Iğdır, 76000
Eda Gülbetekin, 05398612688, edagulbetekin@gmail.com
About this study
Official title: Effects of Turtle-Assisted Animal Interaction on Dental Anxiety and Physiological Parameters in Children: A Randomized Controlled Trial
This study aims to measure the effect of a structured AAT session with a turtle present on dental anxiety and behavioral compliance in children during routine procedures that do not require local anesthesia in a pediatric dental clinic.
Read the detailed description
Dental anxiety is a significant clinical problem in pediatric patients that makes dental visits difficult; it is associated with behavioral management difficulties, appointment avoidance, and reduced access to oral and dental health services. Therefore, reliable measurement of anxiety in pediatric patients and the development of non-pharmacological approaches to reduce anxiety are among the priority areas in the current pediatric dentistry literature. Animal-assisted therapy/interventions (AAT) are being investigated in various health fields as a non-invasive approach that can help reduce stress and anxiety in children. In the context of dentistry, there are studies in which AAT is evaluated with physiological stress markers (heart rate, salivary biomarkers, etc.) and valid self-report scales. In the pediatric dentistry setting, studies conducted especially with "therapy dogs"; Studies have evaluated the effects of the presence of a dog on behavior/anxiety in anxious children during examinations, using crossover randomization and physiological measurements (e.g., salivary cortisol, heart rate, skin conductivity) in some designs. For example, pilot crossover studies with anxious children aged 6-12 years have included scales such as CFSS-DS and objective stress measurements among the measurement tools. More recent clinical studies have also reported the evaluation of efficacy during invasive dental procedures using physiological measurements and validated anxiety/fear/pain scales, with consecutive cases aged 7-14 years divided into AAT and control groups.
This study aims to measure the effect of a structured AAT session with a turtle present on dental anxiety and behavioral compliance in children during routine procedures that do not require local anesthesia in a pediatric dental clinic.
- Conditions
- Animal-Human Bonding, Dental Anxiety, Pediatric Disease
- Being tested
- experimental group, Control Group
- Keywords
- Animal-Human Bonding, Dental Anxiety, Pediatric Disease
- Medical subject headings
- Human-Animal Bond
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimental groupCombination product
Application and Information: Parental consent + child consent form will be obtained. Initial measurement (T0): Anxiety/fear scales + pulse measurement in the waiting area.
Intervention:
- Turtle interaction for a specified duration in the HDT group.
- Standard approach / active control (an activity such as painting) in the control group.
Pre-procedure (T1): Short repeat measurement in the dental chair. Post-procedure (T2): Scale + short satisfaction/experience questions. Possible adverse events (increased fear, crying spell, allergic reaction, etc.) will be recorded.
Control GroupCombination product
After the purpose of the study is explained to the control group by the researcher and written and verbal permission is obtained from those who voluntarily agree to participate in the study, the pre-test data will be collected by the researcher.At the end of the intervention, survey forms will be filled out by the researcher for the control group and post-test data will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: experimental group | Experimental | Participation in the study is entirely voluntary. After the purpose of the study is explained to the experimental group by the researcher and written and verbal permission is obtained from those who voluntarily agree to participate in the study, the pre-test data will be collected by the researcher. Receives: Combination Product: experimental group |
| Experimental: Control Group | Experimental | After the purpose of the study is explained to the control group by the researcher and written and verbal permission is obtained from those who voluntarily agree to participate in the study, the pre-test data will be collected by the researcher. The researcher will fill out the questionnaire forms for the experimental group and collect post-test data. Receives: Combination Product: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corah's Dental Anxiety Scale (CDAS/DAS)
- Measures general dental anxiety related to dentistry.
- Consists of 4 questions; each question is a 5-point Likert scale. • The total score ranges from 4 to 20; the higher the score, the higher the anxiety level. • Developed by Corah, the DAS is one of the classic and widely used scales for measuring dental anxiety and is used as an easily applicable screening tool in various studies.
Measured: through study completion, an average of 1 year
Modified Child Dental Anxiety Scale - faces (MCDASf)
- Measures dental anxiety in children, particularly procedure/stimulus-based fear. • Consists of 8 questions; each question includes a facial expression response option that children can understand. • Each item is scored 1-5; the total score is between 8-40. Higher scores indicate higher anxiety levels. • Due to its facial expression response feature, it is a scale with high comprehensibility, validity, and reliability, particularly in the pediatric age group.
Measured: through study completion, an average of 1 year
Facial Image Scale (FIS)
- Used to quickly assess immediate dental anxiety in children. • Consists of 5 facial expressions (very unhappy → very happy). The child chooses the expression that best reflects their current emotion. • Usually rated on a scale of 1-5; anxiety increases with the selection of more negative expressions. • Developed by Buchanan and Niven, it has been shown to be valid for assessing childhood dental anxiety in clinical settings.
Measured: through study completion, an average of 1 year
Venham Picture Test (VPT)
- Measures dental anxiety using a projective/visual method, especially in younger age groups. • Consists of 8 cards; each card has two figures: one anxious, the other relaxed/calm. • The child chooses the figure they feel closest to; total score 0-8 (higher score = higher anxiety). • Developed for use with children with limited verbal communication; frequently preferred in waiting room and pre-procedure assessments.
Measured: through study completion, an average of 1 year
Frankl Behavior Assessment Scale (Frankl Scale)
- It evaluates the child's observed behavioral compliance/cooperation during dental procedures. • The dentist makes a 4-category observational assessment: "Definitely negative, Negative, Positive, Definitely positive." • It is one of the most commonly used behavioral scales in pediatric dentistry; it allows the operator to practically classify the child's compliance with treatment.
Measured: through study completion, an average of 1 year
Physiological measurement
Pulse
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Mar 2026
- Primary completion1 Aug 2026
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Animal-Human BondingStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Igdir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eda Gulbetekin, Igdir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07439289
- Sponsor's protocol ID
- Eda3
- Other IDs
- Iğdır University
- Acronym
- TAADA
- Status last verified
- Sep 2026
- First submitted
- 16 Feb 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Turtle-Assisted Animal Interaction on Dental Anxiety and Physiological Parameters in Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07439289
- Acronym / sponsor ID
- TAADA / Eda3
- Conditions
- Animal-Human Bonding, Dental Anxiety, Pediatric Disease
- Keywords
- Animal-Human Bonding, Dental Anxiety, Pediatric Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Igdir UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 27 Feb 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.
This study aims to measure the effect of a structured AAT session with a turtle present on dental anxiety and behavioral compliance in children during routine procedures that do not require local anesthesia in a pediatric dental clinic.
Detailed description
Dental anxiety is a significant clinical problem in pediatric patients that makes dental visits difficult; it is associated with behavioral management difficulties, appointment avoidance, and reduced access to oral and dental health services. Therefore, reliable measurement of anxiety in pediatric patients and the development of non-pharmacological approaches to reduce anxiety are among the priority areas in the current pediatric dentistry literature. Animal-assisted therapy/interventions (AAT) are being investigated in various health fields as a non-invasive approach that can help reduce stress and anxiety in children. In the context of dentistry, there are studies in which AAT is evaluated with physiological stress markers (heart rate, salivary biomarkers, etc.) and valid self-report scales. In the pediatric dentistry setting, studies conducted especially with "therapy dogs"; Studies have evaluated the effects of the presence of a dog on behavior/anxiety in anxious children during examinations, using crossover randomization and physiological measurements (e.g., salivary cortisol, heart rate, skin conductivity) in some designs. For example, pilot crossover studies with anxious children aged 6-12 years have included scales such as CFSS-DS and objective stress measurements among the measurement tools. More recent clinical studies have also reported the evaluation of efficacy during invasive dental procedures using physiological measurements and validated anxiety/fear/pain scales, with consecutive cases aged 7-14 years divided into AAT and control groups.
This study aims to measure the effect of a structured AAT session with a turtle present on dental anxiety and behavioral compliance in children during routine procedures that do not require local anesthesia in a pediatric dental clinic.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: experimental group | Experimental | Combination Product: experimental groupParticipation in the study is entirely voluntary. After the purpose of the study is explained to the experimental group by the researcher and written and verbal permission is obtained from those who voluntarily agree to participate in the study, the pre-test data will be collected by the researcher. |
| Experimental: Control Group | Experimental | Combination Product: Control GroupAfter the purpose of the study is explained to the control group by the researcher and written and verbal permission is obtained from those who voluntarily agree to participate in the study, the pre-test data will be collected by the researcher. The researcher will fill out the questionnaire forms for the experimental group and collect post-test data. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 6-10 years
Key exclusion criteria (2 listed)
- • Children with animal phobia / intense fear of turtles (as stated by the child or parent). • Children with immunosuppression or a history of severe allergic diseases. • Children with a dental plan requiring sedation/GA within the last month (due to intense anxiety or systemic illness).
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 |
|---|---|---|
| experimental groupApplication and Information: Parental consent + child consent form will be obtained. Initial measurement (T0): Anxiety/fear scales + pulse measurement in the waiting area. Intervention: * Turtle interaction for a specified duration in the HDT group. * Standard approach / active control (an activity such as painting) in the control group. Pre-procedure (T1): Short repeat measurement in the dental chair. Post-procedure (T2): Scale + short satisfaction/experience questions. Possible adverse events (increased fear, crying spell, allergic reaction, etc.) will be recorded. | Combination product | Experimental: experimental group |
| Control GroupAfter the purpose of the study is explained to the control group by the researcher and written and verbal permission is obtained from those who voluntarily agree to participate in the study, the pre-test data will be collected by the researcher.At the end of the intervention, survey forms will be filled out by the researcher for the control group and post-test data will be collected. | Combination product | Experimental: Control Group |
Primary outcome
Corah's Dental Anxiety Scale (CDAS/DAS)
Time frame: through study completion, an average of 1 year
* Measures general dental anxiety related to dentistry. * Consists of 4 questions; each question is a 5-point Likert scale. • The total score ranges from 4 to 20; the higher the score, the higher the anxiety level. • Developed by Corah, the DAS is one of the classic and widely used scales for measuring dental anxiety and is used as an easily applicable screening tool in various studies.
Modified Child Dental Anxiety Scale - faces (MCDASf)
Time frame: through study completion, an average of 1 year
• Measures dental anxiety in children, particularly procedure/stimulus-based fear. • Consists of 8 questions; each question includes a facial expression response option that children can understand. • Each item is scored 1-5; the total score is between 8-40. Higher scores indicate higher anxiety levels. • Due to its facial expression response feature, it is a scale with high comprehensibility, validity, and reliability, particularly in the pediatric age group.
Facial Image Scale (FIS)
Time frame: through study completion, an average of 1 year
• Used to quickly assess immediate dental anxiety in children. • Consists of 5 facial expressions (very unhappy → very happy). The child chooses the expression that best reflects their current emotion. • Usually rated on a scale of 1-5; anxiety increases with the selection of more negative expressions. • Developed by Buchanan and Niven, it has been shown to be valid for assessing childhood dental anxiety in clinical settings.
Venham Picture Test (VPT)
Time frame: through study completion, an average of 1 year
• Measures dental anxiety using a projective/visual method, especially in younger age groups. • Consists of 8 cards; each card has two figures: one anxious, the other relaxed/calm. • The child chooses the figure they feel closest to; total score 0-8 (higher score = higher anxiety). • Developed for use with children with limited verbal communication; frequently preferred in waiting room and pre-procedure assessments.
Frankl Behavior Assessment Scale (Frankl Scale)
Time frame: through study completion, an average of 1 year
• It evaluates the child's observed behavioral compliance/cooperation during dental procedures. • The dentist makes a 4-category observational assessment: "Definitely negative, Negative, Positive, Definitely positive." • It is one of the most commonly used behavioral scales in pediatric dentistry; it allows the operator to practically classify the child's compliance with treatment.
Physiological measurement
Time frame: through study completion, an average of 1 year
Pulse
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 4 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing experimental group in people with Animal-Human Bonding and Dental Anxiety, run by Igdir 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 4 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: looking for participants now, as of the sponsor's last update on 4 Sep 2026. 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?
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 Eda Gülbetekin, Assoc. Prof. (05398612688, edagulbetekin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corah's Dental Anxiety Scale (CDAS/DAS) (time frame: through study completion, an average of 1 year). The study lists 6 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 4 Sep 2026.