Animal Assisted Therapy in Pediatric Dentistry

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Animal Assisted Therapy's Effects on Young Dental Patients

Conditions
-----------------
Anxiety

Intervention / Treatment
-----------------
* Behavioral: +Short AAT
* Behavioral: +Long AAT
* Behavioral: Active control; NO dog


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 8 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: +Short AAT<br>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. | Behavioral: +Short AAT<br>* Interaction with therapy dog prior to dental exam, cleaning, and simulated radiographs.<br>|
| Experimental: +Long AAT<br>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. | Behavioral: +Long AAT<br>* Interaction with therapy dog throughout dental exam, cleaning, and simulated radiographs.<br>|
| Active Comparator: Active control; NO dog<br>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. | Behavioral: Active control; NO dog<br>* Color dog picture for 3 minutes prior to dental exam, cleaning, and simulated radiographs.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Heart Rate during Dental Exam | Beats per minute during dental exam. Heart rate measured using wrist-worn Shimmer heart rate tracking device. | During dental exam, approximately 2- 5 minutes. | 
| Mean Heart Rate during Dental Cleaning | Beats per minute during dental cleaning. Heart rate measured using wrist-worn Shimmer heart rate tracking device. | During dental cleaning, approximately 2- 5 minutes. | 
| Mean Heart Rate during Dental Radiograph Simulation | Beats per minute during dental radiograph simulation. Heart rate measured using wrist-worn Shimmer heart rate tracking device. | During dental radiograph simulation, approximately 2- 5 minutes. | 
| Salivary Cortisol during Dental Exam | 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. | During dental exam, approximately 1-2 minutes. | 
| Salivary Cortisol during Dental Cleaning | 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. | During dental cleaning, approximately 1-2 minutes. | 
| Salivary Cortisol during Dental Radiograph Simulation | 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. | During dental radiograph simulation, approximately 1-2 minutes. | 
| Salivary Amylase during Dental Exam | 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. | During dental exam, approximately 1-2 minutes. | 
| Salivary Amylase during Dental Cleaning | 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. | During dental cleaning, approximately 1-2 minutes. | 
| Salivary Amylase during Dental Radiograph Simulation | 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. | During dental radiograph simulation, approximately 1-2 minutes. |