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CompletedNCT03059407Updated Feb 21, 2025

Impact of Therapy Dog Presence on Pediatric Echocardiogram

An interventional study of Dog therapy only and Dog plus standard distraction tech in Dog Therapy, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 1 Year to 5 Years. Per ClinicalTrials.gov, last updated 2025-02-21.

Sponsored by Duke University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
138
Allocation
Randomized
Ages
1 Year to 5 Years
Sex
All
01

Study summary

Young children with known or suspected heart disease frequently have difficulty cooperating with a clinically ordered echocardiogram. Current distraction techniques vary in efficacy. There have been no studies examining the use of animal assisted therapy to improve echocardiogram quality and completeness, as well as the patient/parent experience.

Hypotheses:

  1. The presence and interaction of therapy dogs with young children undergoing echocardiography in a clinical setting will result in more complete and higher quality echocardiograms compared to standard distraction techniques.
  2. Parents will report higher visit satisfaction scores and greater exam comfort for their children for echocardiograms performed with the aid of canine assisted therapy compared to use of standard distraction techniques.

Study Activities and Population Group:

Pilot Phase: Introduction of trained therapy dogs (approved by the Pets at Duke Therapy Program) for 10 echocardiograms to observe canine-patient interactions and determine best practices for inclusion of dog/handler team into the echocardiogram protocol.

Study Phase: 150 subjects ages will be selected from all children ages 1 to 5 years presenting for clinically ordered echocardiograms during the study time period. Subjects will be assigned into one of three groups: 1) Canine assisted therapy only; 2) Canine assisted therapy plus standard distraction techniques; and 3) Standard distraction techniques only. Echocardiography reviewers will be blinded to subject study group and will assign quality and completeness score based on validated criteria. Parental satisfaction will be assessed using validated survey tools.

Data analysis and risk/safety issues:

All subjects will be assigned a random subject ID, with the only link to PHI stored in a Duke Redcap database. Statistical testing will be performed with the assistance of Tracy Spears (biostatistician in DCRI) who has assisted with development of testing tools. There are no physical risks associated with the echocardiogram portion of the study, and very minimal risks with the therapy dog portion of the study. Please see "Pets at Duke" policy included in study documents. There is a potential loss of confidentiality, although the only link between subject ID and PHI will be stored in a Duke Recap database.

Read the detailed description

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)
02

Conditions studied

  • Dog Therapy
03

In context

Lead sponsor

Duke University is the lead sponsor of 2,058 studies on the registry; 274 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 165 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 5 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
138 participants (actual)

Study arms

  • Other
    Dog therapy only

    Canine assisted therapy only during echocardiogram

    Behavioral: Dog therapy only

  • Other
    Dog plus standard distraction tech

    Canine assisted therapy plus standard distraction techniques during echocardiogram

    Behavioral: Dog plus standard distraction tech

  • Other
    Standard distraction technique only

    Standard distraction techniques only during echocardiogram.

    Behavioral: Standard distraction techniques only

Interventions

  • BehavioralDog therapy only

    Canine assisted therapy only during echocardiogram

  • BehavioralDog plus standard distraction tech

    Canine assisted therapy plus standard distraction techniques during echo

  • BehavioralStandard distraction techniques only

    Standard distraction techniques (such as watching a movie) only during echocardiogram

06

What researchers measure

Primary outcomes

  1. Quality of echocardiogram

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

    Time frame: 1 hour

Secondary outcomes

  1. Parent satisfaction

    This outcome will be measured by parent questionnaires.

    Time frame: 1 hour

07

Study locations

1 site
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2017 to primary completion in Jun 2024, 85 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 17, 2017
First posted
Feb 23, 2017
StartActual
May 25, 2017
Primary completionActual
Jun 27, 2024
CompletionActual
Jun 27, 2024
Last update
Feb 21, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03059407
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
Feb 23, 2017
Start date
May 25, 2017
Primary completion
Jun 27, 2024
Completion
Jun 27, 2024
Last update
Feb 21, 2025

Study contacts

Piers Barker
principal investigator · Duke University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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