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NCT03059407 · ClinicalTrials.gov registry record · NA
Impact of Therapy Dog Presence on Pediatric Echocardiogram
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 138
- Enrollment target
NCT03059407 is a NA study that has completed, run by Duke University. The registered enrollment target is 138 participants.
The verdict
NCT03059407, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 138 participants
- Enrollment target
Study 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 phys
Interventions
- BEHAVIORAL Dog therapy only
- BEHAVIORAL Dog plus standard distraction tech
- BEHAVIORAL Standard distraction techniques only
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 138 participants |
| Start Date | 2017-05-25 |
| Est. Completion | 2024-06-27 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03059407
The ClinicalTrials.gov registry entry for NCT03059407 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 138 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Dog therapy only is the first listed.
NCT03059407 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03059407 about?
NCT03059407 is a clinical study titled "Impact of Therapy Dog Presence on Pediatric Echocardiogram". 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 complet...
What is the current status of trial NCT03059407?
This trial is currently completed. It is a NA study. The enrollment target is 138 participants. The study started on 2017-05-25. Estimated completion is 2024-06-27.
What interventions are being tested in trial NCT03059407?
The interventions under investigation include: Dog therapy only (BEHAVIORAL), Dog plus standard distraction tech (BEHAVIORAL), Standard distraction techniques only (BEHAVIORAL).
Who is sponsoring clinical trial NCT03059407?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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