Actively Recruiting
Impact of Therapy Dogs on Anxiety and Behavior of Pediatric Dental Patients During Local Anesthesia: A Randomized Controlled Trial
Led by University of Michigan · Updated on 2025-12-03
25
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to find out if having a therapy dog present during the injection of local anesthetic helps children feel more comfortable at the dentist. It focuses on children aged 4 to 12 who need dental care involving numbing medication, as the injection is often the most anxiety-inducing part of dental treatment. The study compares children's behavior and heart rate during injections with and without a therapy dog, exploring a new way to manage anxiety in young dental patients. The study has two groups: one receives standard behavior guidance during local anesthesia, which includes methods like tell-show-do, positive reinforcement, parental presence, and optional nitrous oxide. The other group has a trained therapy dog present in the operatory, which lies on the child during the injection. Participants will undergo at least two dental procedures requiring local anesthesia, allowing comparison between the two approaches. During the dental visits, children's behavior is observed and recorded every 30 seconds from entering the operatory through one minute after the injection, using a standard scale. Heart rate is also monitored at the same intervals. Anxiety levels are assessed before and after the injection, and parents complete a questionnaire afterward. The study is randomized and does not use masking. Participation involves behavioral and physiological assessments during usual dental care procedures.
CONDITIONS
Brief Title
Impact of Therapy Dogs on Child Anxiety and Behavior During Local Anesthesia for Dental Procedures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 4 to 12 years
- Healthy children without significant medical conditions (ASA I or ASA II)
- Scheduled for at least two dental procedures requiring local anesthesia
- Written informed consent from parent or legal guardian
- Verbal assent for children aged 4-9 years; written assent for children aged 10-12 years
You will not qualify if you...
- Known allergies to dogs or animal dander
- Fear or phobia of dogs
- Behavioral disorders that may negatively impact response to a therapy dog
- Previous dental procedures with local anesthesia in the presence of a therapy dog
- Medical conditions affecting vital signs independently of dental procedure (e.g., heart conditions)
- Parental discomfort with therapy dog presence during procedure
- Children classified as "Definitely Negative" in behavior for dental examination (Frankl 1)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - At least two dental procedures scheduled as part of the trial
Participants undergo dental procedures with local anesthesia, experiencing either standard behavior guidance or therapy dog presence during the injection.
2 or more visits for dental procedures with local anesthesia
Trial Site Locations
Total: 1 location
1
University of Michigan School of Dentistry Children's Clinic
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
J
James R Boynton, DDS, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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