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Clinical Trials/NCT06322264
NCT06322264
Recruiting
N/A

Promoting Children's Participation in Conventional X-ray Examinations

Lund University1 site in 1 country220 target enrollmentNovember 5, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Heart Rate Determination
Sponsor
Lund University
Enrollment
220
Locations
1
Primary Endpoint
Variation in heart rate
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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. The questionnaires will be answered by the population -children, parents and the examining radiographer after each examination has been completed and will mainly consist of shorter multiple-choice options with the possibility of extended answers in cases where additions need to be made. For the parts that are common between the three groups, the questions to the children are taken from a questionnaire about children's participation. Parents and radiographers receive the same questions and answers on a Likert scale. A descriptive and comparative analysis will be done with the support of different software, Excel and SPSS.

Registry
clinicaltrials.gov
Start Date
November 5, 2024
End Date
December 10, 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Variation in heart rate

Time Frame: 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

Study Sites (1)

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