Efficacy of a Preparation Intervention for the Management of Children's Pain and Fear During Induction: Help From a Robot Named MEDi
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 2
- 主要终点
- child's pain
研究概览
简要总结
The purpose of this study is to determine if a preparation teaching intervention before IV insertion, taught by MEDi to children and their parents, will lead to lower levels of expected and experienced pain and fear and less distressing pain memories, as compared to children who receive standard care. In addition, it will be examined whether this preparation intervention will lead to greater parental self-efficacy, less anxiety, and less distressing pain memories as compared to controls.
详细描述
The primary aim is to determine the impact of using a humanoid robot in comparison to standard care. This proposal describes the first study in the world to test such novel technology for preparation teaching intervention before IV insertion. This work builds on previous research conducted by the research team and represents a logical next step for this collaborative group. This project team includes established and emerging leaders in pain management research. This will ensure successful implementation and completion of the project. These methods of teaching preparation have the potential for widespread application to other medical procedures and clinical settings (eg. oncology dentistry) and lead to improved health outcomes for children by easing their suffering and improving the quality of their healthcare encounters.
1.2 Research Questions
Research Question 1.) Does preparation administered by a humanoid robot (MEDi) reduce expectancies and experience of pain and fear of IV insertion in children?
Hypothesis 1.) Children who receive preparation by MEDi will report expecting and experiencing lower levels of fear and pain at IV insertion as compared to youth receiving standard care.
Research Question 2.) Does preparation administered by MEDi lead to higher self-efficacy and lower anxiety in parents of children undergoing IV insertion?
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •presenting for general surgery under general anesthesia, and in the American Society of Anesthesiologists class 1 or 2
排除标准
- •patient presenting for day surgery
- •patient requires an intravenous placed in day surgery unit
- •patient cognitively unable to self-report pain
- •patient with a hearing or visual impairment or developmental disability that precludes self-reporting ability
- •family or child that is unable to communicate in English
- •previous allergic reaction to propofol or lidocaine
结局指标
主要结局
child's pain
时间窗: at moment of child's IV start
Faces Pain Scale-Revised (FPS-R) (Hicks, 2001)
次要结局
- parent self-efficacy(30 mins to 3 hours before induction)
- child's fear(at the moment of OR entry)
- children's memory(2 weeks after child's induction)
- parents' memory(2 weeks after child's induction)
- parent anxiety(30 mins to 3 hours before induction)
研究者
Tanya Beran
Professor
University of Calgary