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Impact of Therapy Dog Presence on Pediatric Echocardiogram

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03059407
Recruitment Status : Suspended (Due to COVID-19, the study has been put on hold.)
First Posted : February 23, 2017
Last Update Posted : September 22, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

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. 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.


Condition or disease Intervention/treatment Phase
Dog Therapy Behavioral: Dog therapy only Behavioral: Dog plus standard distraction tech Behavioral: Standard distraction techniques only Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Impact of Animal Assisted Therapy on Quality, Completeness, and Patient and Parental Satisfaction in Children Undergoing Clinical Echocardiography
Actual Study Start Date : May 25, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Dog therapy only
Canine assisted therapy only during echocardiogram
Behavioral: Dog therapy only
Canine assisted therapy only during echocardiogram

Dog plus standard distraction tech
Canine assisted therapy plus standard distraction techniques during echocardiogram
Behavioral: Dog plus standard distraction tech
Canine assisted therapy plus standard distraction techniques during echo

Standard distraction technique only
Standard distraction techniques only during echocardiogram.
Behavioral: Standard distraction techniques only
Standard distraction techniques (such as watching a movie) only during echocardiogram




Primary Outcome Measures :
  1. Quality of echocardiogram [ Time Frame: 1 hour ]
    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.


Secondary Outcome Measures :
  1. Parent satisfaction [ Time Frame: 1 hour ]
    This outcome will be measured by parent questionnaires.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03059407


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Piers Barker Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03059407    
Other Study ID Numbers: Pro00081186
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No