Animal Assisted Therapy's Effects on Dental Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Mean Salivary Cortisol Levels Throughout Dental Visit
研究概览
简要总结
A cross-sectional prospective study measuring physiologic biometrics and perceptions of stress during a dental procedure with or without a therapy dog present.
详细描述
Patients will be consented, enrolled, and assigned to a control group (no dog) or to an experimental group (dog). The patient assigned to the experimental group will be exposed to the therapy animal prior to the dental appointment. Pre-dental procedure and post-dental procedure surveys will be given to all the subjects asking the same questions. Biometric data will be collected by measuring heart rates of the patient/subject during the dental appointment with a Shimmer or Polar device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study:
- •7-17 years of age
- •Patient undergoing 1 quadrant restorative dental procedure requiring a handpiece (e.g. multiple fillings, sealants and/or stainless-steel crowns) and/or extraction(s)
- •History of moderate dental anxiety with a Frankl score of 2-3 based on Epic chart review
- •Exclusion Criteria Subjects presenting with any of the following will not be included in the study:
- •Patients with developmental delay/special needs, Autism Spectrum Disorders (ASDs), craniofacial defects, chronic pain conditions, and/or dental syndromes
- •No history of dental anxiety
- •Moderate to severe allergy to dogs
- •Previous traumatic experience with a dog and/or self-reported fear of dogs
- •Patients who are not receiving dental care requiring a handpiece (for ex, prophylaxis only)
- •Patients with severe, documented xerostomia
- •Patients receiving sedation (pharmacological and conscious sedation) or general anesthesia
- •Patients who will have physical restraints placed during the dental procedure
- •Patient scheduled to have sedation or general anesthesia
- •Severe acute or chronic medical or psychiatric condition(s) that would interfere with the interpretation of results, and in the judgement of the Investigator, would make the subject inappropriate for entry into the trial
- •Patient with developmental/cognitive disability that cannot self-assent, comprehend and follow the requirements of the study based on research site personnel's assessment.
- •Inability or unwillingness of individual and legal guardian/representative to give written informed assent (from child) and consent (from adult).
排除标准
- 未提供
结局指标
主要结局
Mean Salivary Cortisol Levels Throughout Dental Visit
时间窗: Up to end of dental visit; a total average between 60 to 90 minutes
To measure stress levels salivette swab will be placed in child's cheek to absorb saliva.
Mean Salivary Amylase Levels Throughout Dental Visit
时间窗: Up to end of dental visit; a total average between 60 to 90 minutes
To measure stress levels salivette swab will be placed in child's cheek to absorb saliva.
次要结局
未报告次要终点