Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT06725134
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)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
12 Years
Study:
NCT06725134
Study Brief:
Protocol Section:
NCT06725134