Turtle-Assisted Animal Interaction on Dental Anxiety and Physiological Parameters in Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-10
SponsorIgdir University
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
• 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 design
Design model
Crossover
Treatments tested in this trial
experimental group
Combination productApplication 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 Group
Combination productAfter 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Experimental: experimental groupExperimental treatment 1 intervention
Group B: Experimental: Control GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
through study completion, an average of 1 year2
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.
Time frame
through study completion, an average of 1 year3
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.
Time frame
through study completion, an average of 1 year4
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.
Time frame
through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov