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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
225
Interaction with therapy dog prior to dental exam, cleaning, and simulated radiographs.
Interaction with therapy dog throughout dental exam, cleaning, and simulated radiographs.
Color dog picture for 3 minutes prior to dental exam, cleaning, and simulated radiographs.
General & Oral Health Center
Chapel Hill, North Carolina, United States
RECRUITINGMean Heart Rate during Dental Exam
Beats per minute during dental exam. Heart rate measured using wrist-worn Shimmer heart rate tracking device.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During dental radiograph simulation, approximately 1-2 minutes.
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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.
Time frame: 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.
Time frame: 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.
Time frame: During dental radiograph simulation, approximately 1-2 minutes.