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
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:
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.
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:
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.
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:
Pilot phase (3 months):
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.
Study phase (12 months)
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.
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Exclusion Criteria:
Canine assisted therapy only during echocardiogram
Behavioral: Dog therapy only
Canine assisted therapy plus standard distraction techniques during echocardiogram
Behavioral: Dog plus standard distraction tech
Standard distraction techniques only during echocardiogram.
Behavioral: Standard distraction techniques only
Canine assisted therapy only during echocardiogram
Canine assisted therapy plus standard distraction techniques during echo
Standard distraction techniques (such as watching a movie) only during echocardiogram
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
Parent satisfaction
This outcome will be measured by parent questionnaires.
Time frame: 1 hour
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2017 to primary completion in Jun 2024, 85 months.
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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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