Do Therapy Dogs Improve Behavior and Reduce Anxiety in Pediatric Dental Patients?

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to assess whether the presence of a certified therapy dog during dental procedures that require an injection reduces anxiety and improves behavior in pediatric dental patients. The main questions it aims to answer are: Does the presence of a certified therapy dog during dental procedure requiring an injection reduce anxiety and improve behavior in pediatric dental patients? How do the parents of pediatric dental patients who participate in the study view the use of a certified therapy dog in their child's treatment? Does the presence of a certified therapy dog result in different concentrations of microbes in the treatment room? All participants will receive standard of care. Researchers will compare the group with a therapy dog present to a group who does not have a therapy dog present to see if heart rate, oxygen saturation, percentage of nitrous oxide administered, and Frankl scores differ between the groups.

Official Title
-----------------
Do Certified Therapy Dogs Improve Behavior and Reduce Anxiety in Children Who Receive Administration of a Local Anesthetic for Dental Procedures? A Randomized Controlled Trial

Conditions
-----------------
Therapy Animals, Dental Anxiety, Child Behavior, Anesthesia, Local

Intervention / Treatment
-----------------
* Behavioral: Therapy Dog


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 3-7 Children who are patients at the Medical University of South Carolina Department of Pediatric Dentistry Children classified as category 1 or 2 according to the American Society of Anesthesiologists Physical Status Classification Children whose parents/guardians are willing to consent to the child participating in the study Availability of parent to be present during treatment Children who require further care that includes the injection of a local anesthetic and whose procedure will take less than one hour Exclusion Criteria: Patients whose cases are considered emergencies Patients who are classified as category 3 or higher according to the American Society of Anesthesiologists Physical Status Classification (6) If patient's medical status has worsened since initial evaluation Known allergy to dogs or other animals Past history of dental trauma Past history of animal bites or traumatic experience with a dog Emotional or developmental delays If, on the day of the treatment, patient presents with fever or other illness

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 7 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapy Dog<br>This group will have a certified therapy dog present in the treatment room throughout the procedure. Prior to the procedure, the participant will be briefly introduced to the therapy dog and handler, who will remain in the room until the end of the procedure. | Behavioral: Therapy Dog<br>* Certified, volunteer therapy dogs and their handlers will be present in the room during procedures in the experimental arm to see if their presence reduces anxiety and improves behavior in pediatric dental patients.<br>|
| No Intervention: Control<br>The control group receives standard of care and does not have a therapy dog present in the room during their treatment. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioral measure, using the Frankl score | Behavior will be recorded using the Frankl score, which ranges from 1 (definitely negative) to 4 (definitely positive) | This behavior measure will be recorded at four timepoints: 1) immediately before the procedure, 2) during the procedure 3) during the procedure, and 4) immediately after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent survey responses | Parents will be given a short survey about their child's participation in the study. Each arm of the study has its own survey. The survey for the control group is 4 multiple choice questions and one open-ended question. The survey for the experimental group contains 3 multiple choice questions and 1 open-ended question. | The surveys will be administered immediately after the procedure. | 
| Microbial concentration | In the experimental arm, the dental operatory will be swabbed prior to the arrival of the therapy dog and again after the therapy dog as left. For the control group, the operatory will be swabbed. | Experimental group: prior to arrival of therapy dog, and after departure of therapy dog. Control group: prior to arrival of participant, after departure of participant | 
| Anxiety measure, heart rate | The participant's heart rate will be recorded, using a finger pulse oximeter | The heart rate will be recorded at four timepoints: 1) immediately before the procedure, 2) during the procedure 3) during the procedure, and 4) immediately after the procedure | 
| Anxiety measure, oxygen saturation | The participant's oxygen saturation will be recorded, using a finger pulse oximeter | Oxygen saturation will be recorded at four timepoints: 1) immediately before the procedure, 2) during the procedure 3) during the procedure, and 4) immediately after the procedure |