Clinical trial NCT04708028: Animal Assisted Therapy in Dentistry
Official title: Animal Assisted Therapy's Effects on Dental Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: North Carolina Translational and Clinical Sciences Institute
First posted: 2021-01-13
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A cross-sectional prospective study measuring physiologic biometrics and perceptions of stress during a dental procedure with or without a therapy dog present.

Detailed description: Patients will be consented, enrolled, and 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 Shimmer or Polar device.

Eligibility criteria: Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study:

* 7-17 years of age
* Patient undergoing 1 quadrant restorative dental procedure requiring a handpiece (e.g. multiple fillings, sealants and/or stainless-steel crowns) and/or extraction(s)
* 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) or 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).

Primary outcomes:
measure: Mean Salivary Amylase Levels Throughout Dental Visit
timeFrame: Up to end of dental visit; a total average between 60 to 90 minutes
measure: Mean Salivary Cortisol Levels Throughout Dental Visit
timeFrame: Up to end of dental visit; a total average between 60 to 90 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: General & Oral Health Center
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Laura A Jacox, DMD, PhD, MS
role: PRINCIPAL_INVESTIGATOR
References: