- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07439289
Turtle-Assisted Animal Interaction on Dental Anxiety and Physiological Parameters in Children (TAADA)
Effects of Turtle-Assisted Animal Interaction on Dental Anxiety and Physiological Parameters in Children: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eda Gülbetekin, Assoc. Prof.
- Phone Number: 05398612688
- Email: edagulbetekin@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental: experimental group
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.
|
Application and Information: Parental consent + child consent form will be obtained. Initial measurement (T0): Anxiety/fear scales + pulse measurement in the waiting area. Intervention:
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: Control Group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Corah's Dental Anxiety Scale (CDAS/DAS)
Time Frame: through study completion, an average of 1 year
|
|
through study completion, an average of 1 year
|
|
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.
|
through study completion, an average of 1 year
|
|
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.
|
through study completion, an average of 1 year
|
|
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.
|
through study completion, an average of 1 year
|
|
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.
|
through study completion, an average of 1 year
|
|
Physiological measurement
Time Frame: through study completion, an average of 1 year
|
Pulse
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Eda3
- Iğdır University (Other Identifier: Iğdır University)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dental Anxiety
-
Aga Khan University Hospital, PakistanDow University of Health Sciences; Civil Hospital KarachiCompletedDental Anxiety | Dental Fear and AnxietyPakistan
-
Riham AbbasRecruitingDental Anxiety | Dental Fear | Dental Fear and AnxietyEgypt
-
Universidade Federal do Rio Grande do NorteCompletedDental Anxiety | Dental Fear and AnxietyBrazil
-
University of PaviaCompletedDental Anxiety | Dental PhobiaItaly
-
Cairo UniversityUnknownAnxiety, Dental | Fear, Dental
-
St. Justine's HospitalRecruitingDental Anxiety | Dental Trauma | Dental Diseases | Dental PhobiaCanada
-
St. Justine's HospitalCompletedDental Anxiety | Dental Trauma | Dental Diseases | Dental PhobiaCanada
-
Alexandria UniversityNot yet recruitingPediatric Dental Anxiety | Pediatric Dental PainEgypt
-
Ataturk UniversityScientific Research Projects Coordınatıon Unit of Atatürk UniversityRecruiting
-
Selcuk UniversityCompleted
Clinical Trials on experimental group
-
Finis Terrae UniversityNot yet recruitingPostoperative Pain | Respiratory ComplicationChile
-
Riphah International UniversityRecruitingAthletic Performance | Muscle StrengthPakistan
-
Suleyman Demirel UniversityRecruitingOsteoporosis (Senile)Turkey (Türkiye)
-
Riphah International UniversityCompletedEffects of Rhythmic Stabilization With and Without Closed Kinetic Chain Exercises Among Fast BowlersSports Physical TherapyPakistan
-
University of AlcalaRecruitingTo be Approved by the Ethics CommitteeSpain
-
Sahmyook UniversityNot yet recruitingStrokeKorea, Republic of
-
Virginia Commonwealth UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedChronic Low Back Pain | Fear of Pain | Fear of InjuryUnited States
-
Riphah International UniversityCompletedSports Physical TherapyPakistan
-
Ataturk UniversityArtvin Coruh UniversityCompleted