Panda: Evaluation of a Smartphone-based Perioperative Pain Assessment Tool
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Concordance between the electronic and paper versions of the FPS-R and CAS pain scales
研究概览
简要总结
This study will evaluate Panda, a smartphone-based pain assessment tool. During a child's recovery from surgery, a Post-Anesthetic Care Unit nurse will assess their pain, which helps determine what medication they need. Traditionally, this involves asking the child to rate their pain on a scale from 1 to 10, by moving a slider along a coloured scale or pointing to one of a series of faces on a piece of card. The Panda uses the same methods, but presents them on a smartphone screen. Our evaluation will ensure that the Panda gives the same pain scores as the traditional methods.
详细描述
The purpose of this study is to ensure that Panda, a smartphone-based pain assessment tool, can be used effectively by children after surgery and that the pain scores it obtains agree with the scores obtained using traditional methods of pain assessment. In particular the aim is to show agreement (a) between pain scores obtained using Panda and pain scores obtained using the Faces Pain Scale-Revised for 4-12 year olds and (b) between pain scores obtained using Panda and pain scores obtained using the Coloured Analogue Scale (CAS) for 5-18 year olds.
We will recruit children between 4 and 18 years old, in general good health, who are scheduled for surgery. We will exclude any child who has a psychiatric diagnosis, developmental delay or brain injury, significant visual impairment or psychomotor dysfunction.
This study is taking place in the Post-anesthetic Care Unit (PACU) at BC Children's Hospital. We will recruit 200 children in total. The study procedures include the following:
Stage 1 - pre-clinical usability study: we will conduct a series of participatory design sessions with nurses in the PACU and with 20 children in the Surgical Day Care Unit (SDCU)
Stage 2 - clinical validation study: children will be asked to rate their pain using both the Panda and a traditional tool (which is used first will be decided randomly); during this stage, children will also be asked their opinion (e.g. which tool they preferred using and about any problems they experienced using either tool).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing a surgical procedure for which there is an anticipated post-surgical pain model
- •Age 4 - 18 years
- •ASA I-III, not requiring admission to PICU
- •Written parental/guardian informed consent and subject informed assent when required (subject age ≥ 7 years)
排除标准
- •Children who have not undergone a surgical procedure (e.g. MRI, X-ray or endoscopy patients)
- •Inability or refusal to provide informed consent/assent
- •Developmental delay, neurological injury or psychomotor dysfunction
- •Children who have a significant visual impairment or have undergone eye surgery
研究组 & 干预措施
Panda first
Panda evaluation of post-operative pain first, followed by manual method of pain assessment.
干预措施: Panda first followed by manual pain assessment (Device)
Manual first
Manual evaluation of post-operative pain first followed by Panda pain assessment.
干预措施: Manual first followed by Panda pain assessment (Device)
结局指标
主要结局
Concordance between the electronic and paper versions of the FPS-R and CAS pain scales
时间窗: Up to 2 hours following surgery
The study aims to measure concordance between the (a) pain scores obtained using Panda and pain scores obtained using the Faces Pain Scale-Revised for 4-12 year olds and (b) pain scores obtained using Panda and pain scores obtained using the Coloured Analogue Scale (CAS) for 5-18 year olds.
次要结局
未报告次要终点
研究者
Mark Ansermino
Principle Investigator
University of British Columbia