Impact of Therapy Dog Presence on Pediatric Echocardiogram

Design and Procedures:

160 study subjects will be selected from all children 1 to 5 years of age presenting to the
Duke University Pediatric Echocardiography Laboratory for a clinically ordered echocardiogram
during the study period.

Duke University Hospital has an established program for pet therapy that includes bedside
visits from trained and certified therapy dogs. At present, these dog-handler teams are
certified as therapy dogs, and then fulfill additional certification requirements in order to
be allowed into patient rooms. As this program and certification requirements are already
established, this project would be able to liaison with the Pets at Duke program to provide
suitable dog-handler teams for the study. Therapy dog certification requires passage of the
AKC Good Citizen Test as well as instruction and certification through a recognized therapy
dog program (including North Carolina Pet Partners, and Carolina Canines for Service).
Currently, dogs (of any breed) that are certified as therapy dogs undergo evaluation by a
team at Duke University and, if appropriate, are able to perform lobby visits (Level 2 dogs)
or bed/patient room visits (Level 3 dogs). Only Level 3 dogs would be included in this study.

Data Collection:

- Subject demographics (age, ethnicity, gender, birth order, home ZIP code, city/rural
designation)

- Presence and type of heart disease and interventions, if any

- Presence of a dog (breed to be specified) or other pet at home, exposure to other
animals

- History of any traumatic canine experience (fears, bites)

- Presence of parental anxiety with dogs

- Completeness of echocardiogram based on existing protocol QA document

- Quality of echocardiogram (poor, average, good, excellent)

- Time required to perform echocardiogram

- Assessment of echocardiogram complexity (low, medium, high)

- Patient and parental/guardian comfort and satisfaction with echocardiogram experience

- Handler assessment of dog comfort throughout echocardiogram

- Handler assessment of quality of dog-subject interaction

Echocardiography Data Echocardiography completeness, quality, time and complexity will be
assessed by either co-PI, who will be blinded to the subject group or presence of a dog
during the echocardiogram.

- Echo completeness will be assessed using a numerical version of the existing protocol
document used for QA

- Quality of the echocardiogram will be assessed using a qualitative scale derived from
published pediatric echocardiography studies

- Time required to perform echocardiogram will be measured from time stamp on first image
to time stamp on last image, automatically displayed for each echo.

Video Recording of Therapy Dog Interaction with Subject A video recording of the therapy dog
interaction with the subject will be performed. This video review is part of a separate Duke
University study investigating how therapy dogs behave around young children (Duke IACUC
Protocol A112-14-05) and will not be analyzed as part of this study. It is likely that an
image of the subject will be captured on the video, but none of the subject's protected
health information or subject ID number will be included with the video. No video recordings
will be released beyond the therapy dog analysis.

Timeline:

The study will be broken into 4 distinct phases:

1. Initial Phase (3 months): Medical team training and inclusion of study metrics into
daily routine of the Duke University Hospital Pediatric Echocardiography Laboratory.

2. Pilot phase (3 months):

1. 10 non-randomized subjects will be recruited and matched with dog-handler teams

2. Through observation of dog-handler-child behavior and suggested interventions, a
list of techniques will be developed for use in the main study. This will be an
extension of knowledge gained from patient visits performed by therapy dogs in
other settings within Duke Hospital.

i. Suggested interventions may include, but are not limited to: having the dog lie next
to the child on the bed, having the child practice resting their hand on the dog,
demonstrating probe placement on the dog prior to placement on the child c. The
behaviors rated as most helpful by sonographers and dog handlers will be selected as a
list of techniques from which to select for consistent use during the main study.

3. Study phase (12 months)

1. Subjects will be approached for participation and randomized into study group as
outlined above

2. Study data will be collected as outlined above

4. Data analysis and manuscript submission (12 months)

Inclusion Criteria:

- Study subjects will be selected from all children 1 to 5 years of age presenting to
the Duke University Pediatric Echocardiography Laboratory (Duke Peds Echo Lab) for a
clinically ordered echocardiogram during the study time period

Exclusion Criteria:

- parental or child refusal to participate;

- known allergy to dogs;

- fear of dogs;

- concern for overly aggressive child behavior towards the dog;

- or concern for immune system function/infectious risk that could be worsened by animal
exposure.