Animal Assisted Therapy's Effects on Young Dental Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 225
- 试验地点
- 2
- 主要终点
- Mean Heart Rate during Dental Exam
研究概览
简要总结
A prospective randomized trial measuring physiologic biometrics and perceptions of stress during a pediatric dental exam, cleaning, and simulated radiographs with or without a therapy dog present.
详细描述
Patients will be consented, enrolled, and randomly assigned to a control group (no dog) or to an experimental group with dog present only before their dental visit for 3 minutes (+ Short AAT) or to an experimental group with dog present throughout their entire visit (+ Long AAT). Control (no dog) patients will have an active control where they color for 3 minutes before their dental exam, cleaning, and simulated radiographs, without a dog present. Biometric data will be collected with a small wireless wrist device (Shimmer 3) which measures heart rate and sweat response (skin galvanic response). Salivary samples will be taken before and after the dental visit to measure salivary cortisol and amylase, as a metric of physiological stress. Finally, a video feed of body movements during the dental visit will be collected for observational coding. Pre-visit and post-visit surveys will be given to all the patients on their experiences regarding pain, anxiety, and perceptions of the dental experience.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 8 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:
- •4-8 years of age
- •English speaking
- •Qualifies for a dental exam and prophylaxis (cleaning) by having not received a dental prophylaxis or oral exam in the past 3 months
- •Stable physical health, decided at the discretion of the study coordinator and PI
- •Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based on research site personnel's assessment
- •Evidence of a personally signed and dated informed assent form from the child and legal guardian's consent document indicating the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial and all of their questions have been answered
排除标准
- •Subjects presenting with any of the following will not be included in the study:
- •Patients <4yo and >8yo
- •Non-English speakers
- •Patients unwilling to assent/participate or parental/guardian consent was not given
- •Self-report or parental report of patient suffering current dental pain
- •Known allergies or significant adverse reactions following exposure to dogs or the use of oral hygiene products (toothpastes, mouth rinses), and all ingredients in prophy paste
- •Children who are afraid of dogs or had a prior negative experience with dogs as reported by the parent or child
- •Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this trial
- •Developmental/cognitive disability such that patient cannot self-assent, comprehend and follow the requirements of the study based on research site personnel's assessment
研究组 & 干预措施
Active control; NO dog
Children aged 4-8 y.o. willing to receive an oral exam, a toothbrush cleaning, simulated radiographs and be a study participant - 75 control patients who will not be interacting with the dog during their visit and will color a dog picture for 3 minutes instead.
干预措施: Active control; NO dog (Behavioral)
+Short AAT
Children aged 4-8 y.o. willing to receive an oral exam, a toothbrush cleaning, simulated radiographs and be a study participant - 75 experimental patients who will be interacting with the dog prior to their oral exam.
干预措施: +Short AAT (Behavioral)
+Long AAT
Children aged 4-8 y.o. willing to receive an oral exam, a toothbrush cleaning, simulated radiographs and be a study participant - 75 experimental patients who will be interacting with the dog throughout their entire visit.
干预措施: +Long AAT (Behavioral)
结局指标
主要结局
Mean Heart Rate during Dental Exam
时间窗: During dental exam, approximately 2- 5 minutes.
Beats per minute during dental exam. Heart rate measured using wrist-worn Shimmer heart rate tracking device.
Mean Heart Rate during Dental Radiograph Simulation
时间窗: During dental radiograph simulation, approximately 2- 5 minutes.
Beats per minute during dental radiograph simulation. Heart rate measured using wrist-worn Shimmer heart rate tracking device.
Salivary Cortisol during Dental Radiograph Simulation
时间窗: During dental radiograph simulation, approximately 1-2 minutes.
To measure stress levels salivette swab will be placed in child's cheek to absorb saliva. Swabs are spun down for extraction and saliva sample will undergo ELISA assay to measure cortisol level.
Salivary Amylase during Dental Cleaning
时间窗: During dental cleaning, approximately 1-2 minutes.
To measure stress levels salivette swab will be placed in child's cheek to absorb saliva. Swabs are spun down for extraction and saliva sample will undergo ELISA assay to measure cortisol level.
Salivary Amylase during Dental Radiograph Simulation
时间窗: During dental radiograph simulation, approximately 1-2 minutes.
To measure stress levels salivette swab will be placed in child's cheek to absorb saliva. Swabs are spun down for extraction and saliva sample will undergo ELISA assay to measure cortisol level.
Salivary Amylase during Dental Exam
时间窗: During dental exam, approximately 1-2 minutes.
To measure stress levels salivette swab will be placed in child's cheek to absorb saliva. Swabs are spun down for extraction and saliva sample will undergo ELISA assay to measure cortisol level.
Mean Heart Rate during Dental Cleaning
时间窗: During dental cleaning, approximately 2- 5 minutes.
Beats per minute during dental cleaning. Heart rate measured using wrist-worn Shimmer heart rate tracking device.
Salivary Cortisol during Dental Exam
时间窗: During dental exam, approximately 1-2 minutes.
To measure stress levels salivette swab will be placed in child's cheek to absorb saliva. Swabs are spun down for extraction and saliva sample will undergo ELISA assay to measure cortisol level.
Salivary Cortisol during Dental Cleaning
时间窗: During dental cleaning, approximately 1-2 minutes.
To measure stress levels salivette swab will be placed in child's cheek to absorb saliva. Swabs are spun down for extraction and saliva sample will undergo ELISA assay to measure cortisol level.
次要结局
未报告次要终点