Promoting Children's Participation in Conventional X-ray Examinations

Patient Participation Clinical Trial

Official title:

Promoting Children's Participation in Conventional X-ray Examinations

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06322264
• Other study ID #: 2023-05435-01
• Status: Not yet recruiting
• Start date: April 25, 2024
• Est. completion date: April 4, 2025

Study information

• Verified date: April 2024
• Source: Lund University
• Contact: Camilla Viseu, MMedSci
• Phone: +46705425698
• Email: camilla.viseu[@]med.lu.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 220
• Est. completion date: April 4, 2025
• Est. primary completion date: December 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Rate Determination
• Patient Participation

Intervention

Diagnostic Test:
• Measurement of variation in heart rate
The children will be given a portable device that will monitor their heart rate, enabling the recording of the rate of their pulse.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Lund University	Skane University Hospital

References & Publications (3)

Gilljam BM, Arvidsson S, Nygren JM, Svedberg P. Child participation in health care (ChiPaC)-Development and psychometric evaluation of a self-report instrument for children's participation in health care. J Clin Nurs. 2020 Jan;29(1-2):107-118. doi: 10.111 — View Citation

Hardy M, Armitage G. The child's right to consent to x-ray and imaging investigations: issues of restraint and immobilization from a multidisciplinary perspective. J Child Health Care. 2002 Jun;6(2):107-19. doi: 10.1177/136749350200600204. — View Citation

Sahlberg S, Karlsson K, Darcy L. Children's rights as law in Sweden-every health-care encounter needs to meet the child's needs. Health Expect. 2020 Aug;23(4):860-869. doi: 10.1111/hex.13060. Epub 2020 Apr 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation in heart rate	To compare the variations in pulse with the experience of the examination	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)

External Links

•   Almen, A., & Jangland, L., (2020). Radiological examinations in Sweden in 2018 (Report 2020:14). The Radiation Safety Authority.