Dog TherapyNCT03059407
Impact of Therapy Dog Presence on Pediatric Echocardiogram
A study testing Dog therapy only, Dog plus standard distraction tech and Standard distraction techniques only in people with Dog Therapy, run by Duke University at 1 site in United States.
Trial summary
Young children with known or suspected heart disease frequently have difficulty cooperating with a clinically ordered echocardiogram. Current distraction techniques vary in efficacy. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Dog Therapy
- What is being tested?
- Dog therapy only, Dog plus standard distraction tech and Standard distraction techniques only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2017to 27 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Impact of Animal Assisted Therapy on Quality, Completeness, and Patient and Parental Satisfaction in Children Undergoing Clinical Echocardiography
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:
Read more
- 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.
Read the detailed description
Design and Procedures:
160 study subjects will be selected from all children 1 to 5 years of age presenting to the Duke University Pediatric Echocardiography Laboratory for a clinically ordered echocardiogram during the study period.
Duke University Hospital has an established program for pet therapy that includes bedside visits from trained and certified therapy dogs. At present, these dog-handler teams are certified as therapy dogs, and then fulfill additional certification requirements in order to be allowed into patient rooms. As this program and certification requirements are already established, this project would be able to liaison with the Pets at Duke program to provide suitable dog-handler teams for the study. Therapy dog certification requires passage of the AKC Good Citizen Test as well as instruction and certification through a recognized therapy dog program (including North Carolina Pet Partners, and Carolina Canines for Service). Currently, dogs (of any breed) that are certified as therapy dogs undergo evaluation by a team at Duke University and, if appropriate, are able to perform lobby visits (Level 2 dogs) or bed/patient room visits (Level 3 dogs). Only Level 3 dogs would be included in this study.
Data Collection:
- Subject demographics (age, ethnicity, gender, birth order, home ZIP code, city/rural designation)
- Presence and type of heart disease and interventions, if any
- Presence of a dog (breed to be specified) or other pet at home, exposure to other animals
- History of any traumatic canine experience (fears, bites)
- Presence of parental anxiety with dogs
- Completeness of echocardiogram based on existing protocol QA document
- Quality of echocardiogram (poor, average, good, excellent)
- Time required to perform echocardiogram
- Assessment of echocardiogram complexity (low, medium, high)
- Patient and parental/guardian comfort and satisfaction with echocardiogram experience
- Handler assessment of dog comfort throughout echocardiogram
- Handler assessment of quality of dog-subject interaction
Echocardiography Data Echocardiography completeness, quality, time and complexity will be assessed by either co-PI, who will be blinded to the subject group or presence of a dog during the echocardiogram.
- Echo completeness will be assessed using a numerical version of the existing protocol document used for QA
- Quality of the echocardiogram will be assessed using a qualitative scale derived from published pediatric echocardiography studies
- Time required to perform echocardiogram will be measured from time stamp on first image to time stamp on last image, automatically displayed for each echo.
Video Recording of Therapy Dog Interaction with Subject A video recording of the therapy dog interaction with the subject will be performed. This video review is part of a separate Duke University study investigating how therapy dogs behave around young children (Duke IACUC Protocol A112-14-05) and will not be analyzed as part of this study. It is likely that an image of the subject will be captured on the video, but none of the subject's protected health information or subject ID number will be included with the video. No video recordings will be released beyond the therapy dog analysis.
Timeline:
The study will be broken into 4 distinct phases:
- Initial Phase (3 months): Medical team training and inclusion of study metrics into daily routine of the Duke University Hospital Pediatric Echocardiography Laboratory.
- Pilot phase (3 months):
- 10 non-randomized subjects will be recruited and matched with dog-handler teams
- Through observation of dog-handler-child behavior and suggested interventions, a list of techniques will be developed for use in the main study. This will be an extension of knowledge gained from patient visits performed by therapy dogs in other settings within Duke Hospital.
- Suggested interventions may include, but are not limited to: having the dog lie next to the child on the bed, having the child practice resting their hand on the dog, demonstrating probe placement on the dog prior to placement on the child c. The behaviors rated as most helpful by sonographers and dog handlers will be selected as a list of techniques from which to select for consistent use during the main study.
- Study phase (12 months)
- Subjects will be approached for participation and randomized into study group as outlined above
- Study data will be collected as outlined above
- Data analysis and manuscript submission (12 months)
- Conditions
- Dog Therapy
- Being tested
- Dog therapy only, Dog plus standard distraction tech, Standard distraction techniques only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dog therapy onlyBehavioural
Canine assisted therapy only during echocardiogram
Dog plus standard distraction techBehavioural
Canine assisted therapy plus standard distraction techniques during echo
Standard distraction techniques onlyBehavioural
Standard distraction techniques (such as watching a movie) only during echocardiogram
| Study group | Role | What they receive |
|---|---|---|
| Dog therapy only | Other | Canine assisted therapy only during echocardiogram Receives: Behavioral: Dog therapy only |
| Dog plus standard distraction tech | Other | Canine assisted therapy plus standard distraction techniques during echocardiogram Receives: Behavioral: Dog plus standard distraction tech |
| Standard distraction technique only | Other | Standard distraction techniques only during echocardiogram. Receives: Behavioral: Standard distraction techniques only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Secondary outcomes (1)
Parent satisfaction
This outcome will be measured by parent questionnaires.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start25 May 2017
- Primary completion27 Jun 2024
- Study completion27 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dog TherapyStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Piers Barker, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03059407
- Sponsor's protocol ID
- Pro00081186
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2017
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Animal Assisted Therapy on Quality, Completeness, and Patient and Parental Satisfaction in Children Undergoing Clinical Echocardiography
- ClinicalTrials.gov ID
- NCT03059407
- Acronym / sponsor ID
- Pro00081186
- Conditions
- Dog Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 25 May 2017 (actual)
- Primary completion
- 27 Jun 2024 (actual)
- Study completion
- 27 Jun 2024 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Detailed description
Design and Procedures:
160 study subjects will be selected from all children 1 to 5 years of age presenting to the Duke University Pediatric Echocardiography Laboratory for a clinically ordered echocardiogram during the study period.
Duke University Hospital has an established program for pet therapy that includes bedside visits from trained and certified therapy dogs. At present, these dog-handler teams are certified as therapy dogs, and then fulfill additional certification requirements in order to be allowed into patient rooms. As this program and certification requirements are already established, this project would be able to liaison with the Pets at Duke program to provide suitable dog-handler teams for the study. Therapy dog certification requires passage of the AKC Good Citizen Test as well as instruction and certification through a recognized therapy dog program (including North Carolina Pet Partners, and Carolina Canines for Service). Currently, dogs (of any breed) that are certified as therapy dogs undergo evaluation by a team at Duke University and, if appropriate, are able to perform lobby visits (Level 2 dogs) or bed/patient room visits (Level 3 dogs). Only Level 3 dogs would be included in this study.
Data Collection:
- Subject demographics (age, ethnicity, gender, birth order, home ZIP code, city/rural designation)
- Presence and type of heart disease and interventions, if any
- Presence of a dog (breed to be specified) or other pet at home, exposure to other animals
- History of any traumatic canine experience (fears, bites)
- Presence of parental anxiety with dogs
- Completeness of echocardiogram based on existing protocol QA document
- Quality of echocardiogram (poor, average, good, excellent)
- Time required to perform echocardiogram
- Assessment of echocardiogram complexity (low, medium, high)
- Patient and parental/guardian comfort and satisfaction with echocardiogram experience
- Handler assessment of dog comfort throughout echocardiogram
- Handler assessment of quality of dog-subject interaction
Echocardiography Data Echocardiography completeness, quality, time and complexity will be assessed by either co-PI, who will be blinded to the subject group or presence of a dog during the echocardiogram.
- Echo completeness will be assessed using a numerical version of the existing protocol document used for QA
- Quality of the echocardiogram will be assessed using a qualitative scale derived from published pediatric echocardiography studies
- Time required to perform echocardiogram will be measured from time stamp on first image to time stamp on last image, automatically displayed for each echo.
Video Recording of Therapy Dog Interaction with Subject A video recording of the therapy dog interaction with the subject will be performed. This video review is part of a separate Duke University study investigating how therapy dogs behave around young children (Duke IACUC Protocol A112-14-05) and will not be analyzed as part of this study. It is likely that an image of the subject will be captured on the video, but none of the subject's protected health information or subject ID number will be included with the video. No video recordings will be released beyond the therapy dog analysis.
Timeline:
The study will be broken into 4 distinct phases:
- Initial Phase (3 months): Medical team training and inclusion of study metrics into daily routine of the Duke University Hospital Pediatric Echocardiography Laboratory.
- Pilot phase (3 months):
- 10 non-randomized subjects will be recruited and matched with dog-handler teams
- Through observation of dog-handler-child behavior and suggested interventions, a list of techniques will be developed for use in the main study. This will be an extension of knowledge gained from patient visits performed by therapy dogs in other settings within Duke Hospital.
- Suggested interventions may include, but are not limited to: having the dog lie next to the child on the bed, having the child practice resting their hand on the dog, demonstrating probe placement on the dog prior to placement on the child c. The behaviors rated as most helpful by sonographers and dog handlers will be selected as a list of techniques from which to select for consistent use during the main study.
- Study phase (12 months)
- Subjects will be approached for participation and randomized into study group as outlined above
- Study data will be collected as outlined above
- Data analysis and manuscript submission (12 months)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dog therapy only | Other | Behavioral: Dog therapy onlyCanine assisted therapy only during echocardiogram |
| Dog plus standard distraction tech | Other | Behavioral: Dog plus standard distraction techCanine assisted therapy plus standard distraction techniques during echocardiogram |
| Standard distraction technique only | Other | Behavioral: Standard distraction techniques onlyStandard distraction techniques only during echocardiogram. |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dog therapy onlyCanine assisted therapy only during echocardiogram | Behavioural | Dog therapy only |
| Dog plus standard distraction techCanine assisted therapy plus standard distraction techniques during echo | Behavioural | Dog plus standard distraction tech |
| Standard distraction techniques onlyStandard distraction techniques (such as watching a movie) only during echocardiogram | Behavioural | Standard distraction technique only |
Primary outcome
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.
1 secondary outcome
Parent satisfaction
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Piers Barker principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dog therapy only, Dog plus standard distraction tech and Standard distraction techniques only in people with Dog Therapy, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of echocardiogram (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.