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NCT Number: NCT07439289

Turtle-Assisted Animal Interaction on Dental Anxiety and Physiological Parameters in Children

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.

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Key information

Conditions

Animal-Human Bonding Behavior Dental Anxiety Human-Animal Bond Human-Animal Interaction Pediatric Disease

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Igdır University

Iğdır, 76000, Turkey (Türkiye)

Location status: Recruiting

Location contact

Eda Gülbetekin

CONTACT

[email protected]

05398612688

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • • 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.

Treatment and study plan

experimental group

Combination 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 Group

Combination 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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Physiological measurement

    Time frame: through study completion, an average of 1 year

    Pulse

Study contacts

Contact information is provided by the study sponsor or research team.

Eda Gülbetekin, Assoc. Prof.

CONTACT

[email protected]

05398612688

Sponsors and collaborators

Lead sponsor

Igdir University

Other

Registry information

Official study title

Effects of Turtle-Assisted Animal Interaction on Dental Anxiety and Physiological Parameters in Children: A Randomized Controlled Trial

Acronym: TAADA

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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