Animal Assisted Therapy in Dentistry

Study Overview
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Brief Summary
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A cross-sectional prospective randomized study measuring physiologic biometrics and perceptions of stress during a dental procedure with or without a therapy dog present.

Detailed Description
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Patients will be consented, enrolled, and randomly 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 Fitbit.

Official Title
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Animal Assisted Therapy's Effects on Orthodontic Patients

Conditions
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Anxiety

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>No exposure to the therapy dog. | |
| Dog Therapy<br>Introduced to a therapy dog and allowed to pet the dog for up to 2 minutes (timed) prior to the dental procedure. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Heart Rate during Dental Injection | Beats per minute during dental injection. Heart rate measured using wrist-worn Shimmer. | During dental injection, approximately 1 minute. | 
| Mean Heart Rate Post-Dental Procedure | Beats per minute after dental procedure. Heart rate measured using wrist-worn Shimmer. | After dental procedure, approximately 1-2 minutes. | 
| Salivary Cortisol during Dental Injection | To measure stress levels salivette swab will be placed in child's cheek to absorb saliva. | During dental injection, approximately 1 minute. | 
| Salivary Cortisol Post-Dental Procedure | To measure stress levels salivette swab will be placed in child's cheek to absorb saliva. | After dental procedure, approximately 1-2 minutes. | 
| Salivary Amylase during Dental Injection | To measure stress levels salivette swab will be placed in child's cheek to absorb saliva. | During dental injection, approximately 1 minute. | 
| Salivary Amylase Post-Dental Procedure | To measure stress levels salivette swab will be placed in child's cheek to absorb saliva. | After dental procedure, approximately 1-2 minutes. |