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
Overview
- Phase
- N/A
- Intervention
- Therapy Dog
- Conditions
- Therapy Animals
- Sponsor
- Medical University of South Carolina
- Enrollment
- 70
- Locations
- 2
- Primary Endpoint
- Behavioral measure, using the Frankl score
- Status
- Enrolling by Invitation
- Last Updated
- 3 months ago
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Arms & Interventions
Therapy Dog
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.
Intervention: Therapy Dog
Control
The control group receives standard of care and does not have a therapy dog present in the room during their treatment.
Outcomes
Primary Outcomes
Behavioral measure, using the Frankl score
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
Behavior will be recorded using the Frankl score, which ranges from 1 (definitely negative) to 4 (definitely positive)
Secondary Outcomes
- Parent survey responses(The surveys will be administered immediately after the procedure.)
- Anxiety measure, oxygen saturation(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)
- Microbial concentration(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 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)