Impact of Animal Assisted Therapy on Quality, Completeness, and Patient and Parental Satisfaction in Children Undergoing Clinical Echocardiography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 2
- 主要终点
- Quality of echocardiogram
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Quality of echocardiogram
时间窗: 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.
次要结局
- Parent satisfaction(1 hour)