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临床试验/NCT02435498
NCT02435498已完成不适用

A Web-based Education Module Versus Standard of Care for Pain Management Following a Fracture in Children: a Randomized Controlled Trial

Lawson Health Research Institute2 个研究点 分布在 1 个国家目标入组 311 人开始时间: 2015年9月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
311
试验地点
2
主要终点
Change in 21-item knowledge questionnaire total score between groups

研究概览

简要总结

This study's objectives are as follows:

  1. To evaluate the utility of a website to provide information and guidance about pain management in children 2. To educate parents about the pathophysiology of pain, proper use of analgesic medications and signs of pain in children 3. To reduce the functional impact of pain in children following treatment for fracture 4. To endow parents with confidence to manage their child's pain at home 5. To dispel misconceptions about the use and safety of analgesics in children 6. To increase awareness of complications of fractures such as compartment syndrome

详细描述

This study will compare the effectiveness of three mediums of parental education among parents of children treated for non-operative fractures in the emergency department (ED): 1) A novel website entitled, "Online User-Centered Home Pain Management for Fractures" (OUCH PMF) 2) An online educational video (OV) and 3) standard discharge instructions (SOC). The investigators primary goal is to see which modality results in a greater improvement in scores on a on a knowledge questionnaire. The investigators secondary goals are to see which modality results in better parental satisfaction, confidence in managing pain, and lower impact of injury on the child and family. As participants will receive the standard-of-care that includes a pamphlet on how to take care of the cast. During their stay in the ED, participants will be randomly assigned to one of the three aforementioned groups. Participants will then be given the pre-intervention knowledge questionnaire, followed by the intervention and then the post-intervention knowledge questionnaire, prior to being discharged. At 120 hours post-discharge, participants will be asked to access an online survey to obtain information about the functional impact of the injury on their child. The investigators goal is to compare online and video education tools in their ability to improve parental knowledge, confidence, and satisfaction regarding the treatment of fracture pain.

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
Single (Outcomes Assessor)

入排标准

年龄范围
— 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • All caregivers who are in attendance with their child (any age) for a primary complaint of a non-operative fracture managed by the paediatric emergency physician AND will be the primary caregiver for the child at home.

排除标准

  • Poor parental English fluency
  • Lack of a home computer with Internet access
  • Child with a history of renal disease, liver disease, bleeding diathesis, chronic pain issues, or pregnancy.

结局指标

主要结局

Change in 21-item knowledge questionnaire total score between groups

时间窗: 120 hours

次要结局

  • Number of days before resumption of normal diet for child(120 hours)
  • Parental confidence in recognizing pain and providing analgesia using a 5-point Likert scale(120 hours)
  • Number of days of school missed for child(120 hours)
  • Number of days of work missed for parent(120 hours)
  • Number of sleep-interrupted nights for child(120 hours)
  • Other educational resources used(120 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Naveen Poonai

Principal Investigator

Lawson Health Research Institute

研究点 (2)

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