Animal Assisted Therapy in Dentistry

  • STATUS
    Recruiting
  • End date
    Feb 26, 2026
  • participants needed
    120
  • sponsor
    University of North Carolina, Chapel Hill
Updated on 26 August 2021

Summary

A cross-sectional prospective randomized study measuring physiologic biometrics and perceptions of stress during an orthodontic procedure with or without a therapy dog present.

Description

Patients will be consented, enrolled, and randomly assigned to a control group (no dog) or to an experimental group (dog). The patient assigned to the experimental group will be exposed to the therapy animal prior to the dental appointment. Pre-dental procedure and post- dental procedure surveys will be given to all the subjects asking the same questions. Biometric data will be collected by measuring heart rates of the patient/subject during the dental appointment with a Fitbit.

Details
Condition ANXIETY NEUROSIS, Anxiety, Anxiety Symptoms, Anxiety Disorders, anxiety disorder, anxious
Clinical Study IdentifierNCT04708028
SponsorUniversity of North Carolina, Chapel Hill
Last Modified on26 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects must meet all of the following inclusion criteria
to be eligible for enrollment in the study
-17 years of age
Patient undergoing 1 quadrant restorative dental procedure requiring a handpiece (e.g. multiple fillings, sealants and/or stainless-steel crowns)
History of moderate dental anxiety with a Frankl score of 2-3 based on Epic chart review
Exclusion Criteria Subjects presenting with any of the following will not be
included in the study
Patients with developmental delay/special needs, Autism Spectrum Disorders (ASDs), craniofacial defects, chronic pain conditions, and/or dental syndromes
No history of dental anxiety
Moderate to severe allergy to dogs
Previous traumatic experience with a dog and/or self-reported fear of dogs
Patients who are not receiving dental care requiring a handpiece (for ex, prophylaxis only)
Patients with severe, documented xerostomia
Patients receiving sedation (pharmacological and conscious sedation), nitrous oxide, general anesthesia
Patients who will have physical restraints placed during the dental procedure
Patient scheduled to have sedation or general anesthesia
Severe acute or chronic medical or psychiatric condition(s) that would interfere with the interpretation of results, and in the judgement of the Investigator, would make the subject inappropriate for entry into the trial
Patient with developmental/cognitive disability that cannot self-assent, comprehend and follow the requirements of the study based on research site personnel's assessment
Inability or unwillingness of individual and legal guardian/representative to give written informed assent (from child) and consent (from adult)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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