RecruitingNot ApplicableNCT05464888
Animal Assisted Therapy in Pediatric Dentistry
Animal Assisted Therapy's Effects on Young Dental Patients
Sponsor
University of North Carolina, Chapel Hill
Enrollment
225 participants
Start Date
Feb 2, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
A prospective randomized trial measuring physiologic biometrics and perceptions of stress during a pediatric dental exam, cleaning, and simulated radiographs with or without a therapy dog present.
Eligibility
Min Age: 4 YearsMax Age: 8 Years
Inclusion Criteria6
- years of age
- English speaking
- Qualifies for a dental exam and prophylaxis (cleaning) by having not received a dental prophylaxis or oral exam in the past 3 months
- Stable physical health, decided at the discretion of the study coordinator and PI
- Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based on research site personnel's assessment
- Evidence of a personally signed and dated informed assent form from the child and legal guardian's consent document indicating the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial and all of their questions have been answered
Exclusion Criteria8
- Patients \<4yo and \>8yo
- Non-English speakers
- Patients unwilling to assent/participate or parental/guardian consent was not given
- Self-report or parental report of patient suffering current dental pain
- Known allergies or significant adverse reactions following exposure to dogs or the use of oral hygiene products (toothpastes, mouth rinses), and all ingredients in prophy paste
- Children who are afraid of dogs or had a prior negative experience with dogs as reported by the parent or child
- Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this trial
- Developmental/cognitive disability such that patient cannot self-assent, comprehend and follow the requirements of the study based on research site personnel's assessment
Interventions
BEHAVIORAL+Short AAT
Interaction with therapy dog prior to dental exam, cleaning, and simulated radiographs.
BEHAVIORAL+Long AAT
Interaction with therapy dog throughout dental exam, cleaning, and simulated radiographs.
BEHAVIORALActive control; NO dog
Color dog picture for 3 minutes prior to dental exam, cleaning, and simulated radiographs.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05464888
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