Do Therapy Dogs Improve Behavior and Reduce Anxiety in Pediatric Dental Patients? (NCT06057090) | Clinical Trial Compass
TerminatedNot Applicable
Do Therapy Dogs Improve Behavior and Reduce Anxiety in Pediatric Dental Patients?
Stopped: We could not recruit enough participants.
United States41 participantsStarted 2023-09-13
Plain-language 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.
Who can participate
Age range
3 Years – 7 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Behavioral measure, using the Frankl score
Timeframe: 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