Impact of Therapy Dog Presence on Pediatric Echocardiogram

NCT03059407 | Completed

• 1 other identifier: Pro00081186
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Dog Therapy

Outcome Measures

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.

  1 hour

Secondary Outcomes (1)

• Parent satisfaction

  1 hour

Study Arms (3)

Dog therapy only

OTHER

Canine assisted therapy only during echocardiogram

Behavioral: Dog therapy only

Dog plus standard distraction tech

OTHER

Canine assisted therapy plus standard distraction techniques during echocardiogram

Behavioral: Dog plus standard distraction tech

Standard distraction technique only

OTHER

Standard distraction techniques only during echocardiogram.

Behavioral: Standard distraction techniques only

Interventions

Dog therapy only BEHAVIORAL

Canine assisted therapy only during echocardiogram

Dog therapy only

Dog plus standard distraction tech BEHAVIORAL

Canine assisted therapy plus standard distraction techniques during echo

Dog plus standard distraction tech

Standard distraction techniques only BEHAVIORAL

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

Standard distraction technique only

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Study Officials

• Piers Barker

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 17, 2017
• First Posted: February 23, 2017
• Study Start: May 25, 2017
• Primary Completion: June 27, 2024
• Study Completion: June 27, 2024
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)