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临床试验/NCT06322264
NCT06322264招募中不适用

Promoting Children's Participation in Conventional X-ray Examinations

Lund University2 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2024年11月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
220
试验地点
2
主要终点
Variation in heart rate

研究概览

简要总结

The goal of this explorative observational study is to map the procedure and child centered approach in the examination for children that undergo conventional X-ray examinations. The main questions aim to answer:

  • How many images need to be retaken during conventional X-ray examinations?
  • What is the reason why the pictures need to be redone?
  • What is the time required for the various examinations?
  • What experience of the procedure of the examination is there among those involved?
  • Can the physical impact be observed through variation in heart rate in children that undergo conventional X-ray examinations?

Participants will answer questionnaires about the children's participation in the procedure and the variation in heart rate will be measured on the children who undergo the examinations.

详细描述

Many children receive healthcare services during their childhood. In Sweden, approximately 330,000 children aged 0-15 require conventional X-ray examinations annually. It is imperative that the justification for conducting these X-ray examinations on children is carefully considered. Improper positioning during the image capturing process can result in inadequate images that do not provide necessary diagnostic information. This may require that the X-ray procedure must be repeated, leading to unnecessary exposure of children to radiation. This situation poses complexities as a means to minimize the occurrence of repeated imaging procedures and minimize unnecessary radiation exposure, children may be subject to some level of restraint.

Effective January 1, 2020, Sweden adopted the United Nations Convention on the Rights of the Child into law, with the aim of enhancing and elucidating the rights of children.

This entails that children are entitled to receive care from personnel who possess the expertise and qualifications necessary to uphold both the physical and mental well-being of children, as well as their rights, prior to, during, and following a procedure such as an X-ray examination.

The radiographer plays a significant role in determining the outcome of pediatric examinations, impacting both the child's experience and the quality of imaging as well as the radiation dose received. This study investigates the perceptions of health care professionals regarding pediatric examinations, focusing on procedure, child centered approach, and overall experience during conventional X-ray procedures. Additionally, it explores the experiences of children and their parents during examinations, including children's level of participation in the process. It is also essential to evaluate the physical indicators, this in the form of changes in the child's pulse rate.

To establish a standard baseline for normal variation, investigators will measure pulse rates before, during, and after an examination using portable heart rate monitors.

研究设计

研究类型
Observational
观察模型
Family Based
时间视角
Cross Sectional

入排标准

年龄范围
4 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children ages 4-12 yrs who undergo standard x-ray examinations
  • parents to the child
  • assigned radiographers

排除标准

  • Children and parents who have cognitive and/or language difficulties

研究组 & 干预措施

Pediatric patients

Pediatric patients between the ages of 4 and 12 undergoing conventional X-ray examinations.

干预措施: Measurement of variation in heart rate (Diagnostic Test)

Parents

Parents of the included pediatric patients between the ages of 4 and 12 undergoing conventional X-ray examinations.

Radiographers

Radiographers who examine the included pediatric patients between the ages of 4 and 12 undergoing conventional X-ray examinations.

结局指标

主要结局

Variation in heart rate

时间窗: The measurement is done through the examination total time 15 minutes (baseline before start 1-2 minutes, start of exam 2-10 minutes, end of exam after 10-15 minutes)

To compare the variations in pulse with the experience of the examination

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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