Using Artificial Intelligence (AI) - Enhanced Social Robots to Improve Children's Healthcare Experiences
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 4
- 主要终点
- Self-reported pain level
研究概览
简要总结
Children experience pain and distress in clinical settings every day. The negative consequences of unaddressed pain can be both short-term (e.g. fear, distress, inability to perform procedures) and long-term (e.g. needle phobia, anxiety).
In previous small studies, a humanoid robot has been used to deliver cognitive-behavioural therapy during needle procedures. The results of these early studies have been positive, showing high acceptance among children as well as promising initial clinical results. However, these studies all had critical technical limitations: the robot was remotely operated and used purely scripted behaviour with limited Artificial Intelligence support. This reduced the potential to offer personalized support to children. In this project, the study team aims to address this limitation by developing and evaluating a clinically relevant and responsive artificial intelligence-enhanced social robot.
详细描述
PURPOSE:
The study team aims to develop and evaluate an artificial intelligence-enhanced socially intelligent robot designed to alleviate children's distress and pain in a clinical setting.
HYPOTHESIS:
The study team believes that interaction with a robust, adaptive, socially intelligent robot can effectively distract children during painful clinical procedures, thereby reducing pain and distress.
JUSTIFICATION:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •child aged 5-11 years
- •requires IVI
- •will receive topical anesthetic for IVI
排除标准
- •medically unstable (CTAS 1, requiring immediate IV insertion)
- •unconscious or not fully alert
- •visual or auditory impairments
- •neurocognitive delays or mental health issues precluding safe interaction with the robot intervention
- •sensory impairment to pain (ex. spina bifida)
- •parental or child language barrier precluding the ability to understand and complete study assessments, in the absence of a native language translator
- •not accompanied by legal guardian
- •previous enrolment in this clinical trial or in the co-design or usability studies
- •other reason at the discretion of the clinical staff
结局指标
主要结局
Self-reported pain level
时间窗: Scores will be taken 5 minutes before intravenous intervention and immediately after intravenous insertion (approximately 3-4 minutes post-procedure)
Compare the reduction of pain with the use of distraction (via the robot intervention) versus current standard of care in children aged 5 to 11 years who are undergoing IVI. The investigators will use the following scales: \- Pain score: Faces Pain Scale-Revised (score: 0-10; 10 being worst pain)
Self-reported distress level
时间窗: Scores will be taken 5 minutes before intravenous intervention and immediately after intravenous insertion (approximately 3-4 minutes post-procedure)
Compare the reduction of pain and distress with the use of distraction (via the robot intervention) versus current standard of care in children aged 5 to 11 years who are undergoing IVI. The investigators will use the following scales: \- Distress score: Numerical rating scale (score: 0-10; 10 being most distressed)
Self-reported pain level
时间窗: Scores will be taken 5 minutes before intravenous intervention and immediately after intravenous insertion (approximately 3-4 minutes post-procedure)
Compare the reduction of pain with the use of distraction (via the robot intervention) versus current standard of care in children aged 5 to 11 years who are undergoing IVI. The investigators will use the following scales: \- Pain score: Faces Pain Scale-Revised (score: 0-10; 10 being worst pain)
Self-reported distress level
时间窗: Scores will be taken 5 minutes before intravenous intervention and immediately after intravenous insertion (approximately 3-4 minutes post-procedure)
Compare the reduction of pain and distress with the use of distraction (via the robot intervention) versus current standard of care in children aged 5 to 11 years who are undergoing IVI. The investigators will use the following scales: \- Distress score: Numerical rating scale (score: 0-10; 10 being most distressed)
次要结局
- Self-reported fear level(Scores will be taken 5 minutes before intravenous intervention and immediately after intravenous insertion (approximately 3-4 minutes post-procedure))
- Parental/caregiver anxiety(Scores will be taken 5 minutes before intravenous intervention and immediately after intravenous insertion (approximately 3-4 minutes post-procedure))
- Satisfaction with procedure(Outcome will be measured immediately after intravenous insertion (approximately 3-4 minutes post-procedure))
- Engagement(Outcome will be measured immediately after intravenous insertion (approximately 3-4 minutes post-procedure))
- Self-reported fear level(Scores will be taken 5 minutes before intravenous intervention and immediately after intravenous insertion (approximately 3-4 minutes post-procedure))
- Parental/caregiver anxiety(Scores will be taken 5 minutes before intravenous intervention and immediately after intravenous insertion (approximately 3-4 minutes post-procedure))
- Satisfaction with procedure(Outcome will be measured immediately after intravenous insertion (approximately 3-4 minutes post-procedure))
- Engagement(Outcome will be measured immediately after intravenous insertion (approximately 3-4 minutes post-procedure))