Effects of Turtle-Assisted Animal Interaction on Dental Anxiety and Physiological Parameters in Children: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Corah's Dental Anxiety Scale (CDAS/DAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •• 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.
研究组 & 干预措施
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.
干预措施: experimental group (Combination Product)
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.
干预措施: Control Group (Combination Product)
结局指标
主要结局
Corah's Dental Anxiety Scale (CDAS/DAS)
时间窗: 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.
Modified Child Dental Anxiety Scale - faces (MCDASf)
时间窗: 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.
Facial Image Scale (FIS)
时间窗: 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.
Venham Picture Test (VPT)
时间窗: 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.
Frankl Behavior Assessment Scale (Frankl Scale)
时间窗: 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.
Physiological measurement
时间窗: through study completion, an average of 1 year
Pulse
次要结局
未报告次要终点
研究者
Eda Gulbetekin
Assoc. Prof.
Igdir University