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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03059407|
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : March 12, 2021
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.
- 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.
- 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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|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 2021|
|Estimated Study Completion Date :||December 2021|
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
- 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.
- Parent satisfaction [ Time Frame: 1 hour ]This outcome will be measured by parent questionnaires.
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
|Contact: Kimberly Carrollfirstname.lastname@example.org|
|Contact: Piers Barker, MDemail@example.com|
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Mingfen Xu, MSN 919-668-6352 firstname.lastname@example.org|
|Principal Investigator: Piers Barker, MD|
|Principal Investigator:||Piers Barker||Duke University|