NCT06725134 Impact of Therapy Dogs on Child Anxiety and Behavior During Local Anesthesia for Dental Procedures
| NCT ID | NCT06725134 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Michigan |
| Condition | Situational Anxiety |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2024-11-01 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Therapy dogs in dental offices might help anxious children during dental care. Therapy dogs might help children during injection of local anesthetic, when we inject numbing medication before working on the teeth. The goal of this study is to learn if having a therapy dog with a child during the injection of numbing medication helps children to be more comfortable at the dentist's office. This study is of children who need dental care using local anesthesia. Study participant's behavioral reactions and heart rate during injection of local anesthetic with and without having a therapy dog present will be recorded and children and their guardians will be asked a few short questions about the injection and therapy dog after injection.
Eligibility Criteria
Inclusion Criteria: * Age range: children aged 4- to 12-years * Health status: healthy children without significant medical conditions (ASA I or ASA II) * Dental procedure: children scheduled for at least two dental procedures requiring local anesthesia * Consent: written informed consent from the parent or legal guardian * Verbal assent from potential subjects age 4-9 years; written assent for children age 10-12 years Exclusion Criteria: * Allergies: children with known allergies to dogs or animal dander * Children with a fear or phobia of dogs * Children with a behavioral disorder which may negatively impact response to the presence of a therapy dog * Previous exposure: children who have previously undergone dental procedures with local anesthesia in the presence of a therapy dog * Medical conditions: children with medical conditions that might affect their vital signs independently of the dental procedure (e.g., heart conditions) * Parental discomfort: cases where parents are uncomfortable with the presence of a therapy dog during the procedure * Advanced behavior guidance is indicated: children whose behavior for dental examination is classified as "Definitely Negative" (Frankl 1)
Contact & Investigator
James R. Boynton, DDS, MS
PRINCIPAL INVESTIGATOR
University of Michigan
Frequently Asked Questions
Who can join the NCT06725134 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 12 Years, studying Situational Anxiety. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06725134 currently recruiting?
Yes, NCT06725134 is actively recruiting participants. Contact the research team at jboynton@umich.edu for enrollment information.
Where is the NCT06725134 trial being conducted?
This trial is being conducted at Ann Arbor, United States.
Who is sponsoring the NCT06725134 clinical trial?
NCT06725134 is sponsored by University of Michigan. The principal investigator is James R. Boynton, DDS, MS at University of Michigan. The trial plans to enroll 25 participants.
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