Clinical trial NCT05464888: Animal Assisted Therapy in Pediatric Dentistry
Official title: Animal Assisted Therapy's Effects on Young Dental Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 225
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: Patients will be consented, enrolled, and randomly assigned to a control group (no dog) or to an experimental group with dog present only before their dental visit for 3 minutes (+ Short AAT) or to an experimental group with dog present throughout their entire visit (+ Long AAT). Control (no dog) patients will have an active control where they color for 3 minutes before their dental exam, cleaning, and simulated radiographs, without a dog present. Biometric data will be collected with a small wireless wrist device (Shimmer 3) which measures heart rate and sweat response (skin galvanic response). Salivary samples will be taken before and after the dental visit to measure salivary cortisol and amylase, as a metric of physiological stress. Finally, a video feed of body movements during the dental visit will be collected for observational coding. Pre-visit and post-visit surveys will be given to all the patients on their experiences regarding pain, anxiety, and perceptions of the dental experience.

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

* 4-8 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 Criteria: Subjects presenting with any of the following will not be included in the study:

* 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

Primary outcomes:
measure: Mean Heart Rate during Dental Exam
timeFrame: During dental exam, approximately 2- 5 minutes.
measure: Mean Heart Rate during Dental Cleaning
timeFrame: During dental cleaning, approximately 2- 5 minutes.
measure: Mean Heart Rate during Dental Radiograph Simulation
timeFrame: During dental radiograph simulation, approximately 2- 5 minutes.
measure: Salivary Cortisol during Dental Exam
timeFrame: During dental exam, approximately 1-2 minutes.
measure: Salivary Cortisol during Dental Cleaning
timeFrame: During dental cleaning, approximately 1-2 minutes.
measure: Salivary Cortisol during Dental Radiograph Simulation
timeFrame: During dental radiograph simulation, approximately 1-2 minutes.
measure: Salivary Amylase during Dental Exam
timeFrame: During dental exam, approximately 1-2 minutes.
measure: Salivary Amylase during Dental Cleaning
timeFrame: During dental cleaning, approximately 1-2 minutes.
measure: Salivary Amylase during Dental Radiograph Simulation
timeFrame: During dental radiograph simulation, approximately 1-2 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: