NCT07439289

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Mar 2026Sep 2026

First Submitted

Initial submission to the registry

February 16, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

July 24, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

February 16, 2026

Last Update Submit

July 23, 2026

Conditions

Keywords

Animal-Human BondingDental AnxietyPediatric Disease

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    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.

    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.

    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.

    through study completion, an average of 1 year

  • Physiological measurement

    Pulse

    through study completion, an average of 1 year

Study Arms (2)

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.

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.

Combination Product: Control Group

Interventions

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.

Experimental: experimental group
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.

Experimental: Control Group

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Igdır University

Iğdır, Iğdır, 76000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Human-Animal Bond

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Human-Animal InteractionBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

Eda Gülbetekin, Assoc. Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

February 16, 2026

First Posted

February 27, 2026

Study Start

March 1, 2026

Primary Completion

June 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

July 24, 2026

Record last verified: 2026-02

Locations