Animal Assisted Therapy in Pediatric Dentistry (AAT)

University of North Carolina (UNC)

Status: Enrolling

Conditions: Anxiety

Treatments: Behavioral: Active control; NO dog; Behavioral: +Long AAT; Behavioral: +Short AAT

Study type: Interventional

Funder types: Other

Identifiers

NCT05464888

22-1454

Details and patient eligibility

About

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.

Full 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.

Enrollment: 225 estimated patients

Sex: All

Ages: 4 to 8 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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225 participants in 3 patient groups

+Short AAT

Experimental group

Description:

Children aged 4-8 y.o. willing to receive an oral exam, a toothbrush cleaning, simulated radiographs and be a study participant - 75 experimental patients who will be interacting with the dog prior to their oral exam.

Treatment:

Behavioral: +Short AAT

+Long AAT

Experimental group

Description:

Children aged 4-8 y.o. willing to receive an oral exam, a toothbrush cleaning, simulated radiographs and be a study participant - 75 experimental patients who will be interacting with the dog throughout their entire visit.

Treatment:

Behavioral: +Long AAT

Active control; NO dog

Active Comparator group

Description:

Children aged 4-8 y.o. willing to receive an oral exam, a toothbrush cleaning, simulated radiographs and be a study participant - 75 control patients who will not be interacting with the dog during their visit and will color a dog picture for 3 minutes instead.

Treatment:

Behavioral: Active control; NO dog