Impact of Therapy Dog Presence on Pediatric Echocardiogram

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.

Conditions

• Dog Therapy

Interventions

BEHAVIORAL

Dog therapy only

Canine assisted therapy only during echocardiogram

BEHAVIORAL

Dog plus standard distraction tech

Canine assisted therapy plus standard distraction techniques during echo

BEHAVIORAL

Standard distraction techniques only

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

Sponsors & Collaborators

• Duke University

  lead OTHER

Principal Investigators

• Piers Barker · Duke University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

5 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-05-25

Primary Completion

2024-06-27

Completion

2024-06-27

Countries

• United States

Study Locations