Anesthesia, Local, Child Behavior, Dental Anxiety, Therapy Animals
Conditions
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.
Interventions
BEHAVIORALTherapy Dog
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.
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 7 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Behavioral measure, using the Frankl score | 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
| Measure | Time frame | Description |
|---|---|---|
| Parent survey responses | The surveys will be administered immediately after the procedure. | 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. |
| 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 | 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. |
| 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 | The participant's heart rate will be recorded, using a finger pulse oximeter |
| 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 | The participant's oxygen saturation will be recorded, using a finger pulse oximeter |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJulie L Marshall, PhD
James B. Edwards College of Dental Medicine, Medical University of South Carolina
Outcome results
None listed