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

N/AEnrolling By InvitationNCT06057090

Medical University of South Carolina70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Therapy Animals Dental Anxiety Child Behavior

Eligibility

Sex: ALLMin age: 3 YearsMax age: 7 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Behavioral measure, using the Frankl score

Behavior will be recorded using the Frankl score, which ranges from 1 (definitely negative) to 4 (definitely positive)

Time frame: 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 Outcomes

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.

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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