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

Official title

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

Overview

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.

Interventions

• Combination product experimental group
  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 even
• Combination product 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.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 outcome measures

• Corah's Dental Anxiety Scale (CDAS/DAS) [Time frame: 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]
• Facial Image Scale (FIS) [Time frame: through study completion, an average of 1 year]
• Venham Picture Test (VPT) [Time frame: through study completion, an average of 1 year]
• Frankl Behavior Assessment Scale (Frankl Scale) [Time frame: through study completion, an average of 1 year]
• Physiological measurement [Time frame: through study completion, an average of 1 year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Quadruple blind

Primary purpose

Supportive care

Study locations

Turkey (Türkiye) · 1 center

• Igdır University — Iğdır

Identifiers

NCT: NCT07439289 · Eda3 · Iğdır University

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗