Promoting Children's Participation in Conventional X-ray Examinations

NCT06322264 | Recruiting

• 1 other identifier: 2023-05435-01
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Rate Determination; Patient Participation

Keywords

Children's participation; Conventional x-ray procedure; Variation in heart rate

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (3)

Pediatric patients

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

Diagnostic Test: Measurement of variation in heart rate

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.

Interventions

Measurement of variation in heart rate DIAGNOSTIC_TEST

The children will be given a portable device that will monitor their heart rate, enabling the recording of the rate of their pulse.

Pediatric patients

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The population consists of the people who are involved with the child undergoing an X-ray examination. Which are the children who are to undergo conventional x-rays and are between the ages of 4-12 years. Those who are accompanying this child and the radiographers who carry out the examination will also be there.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Lund University: lead
• Skane University Hospital: collaborator

Study Sites (1)

SUS

Lund, Skåne County, 221 00, Sweden

RECRUITING

Related Publications (3)

• 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.

  PMID: 12136815 BACKGROUND

• 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.

  PMID: 32319716 RESULT

• 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: 10.1111/jocn.15063. Epub 2019 Oct 10.

  PMID: 31531995 RESULT

Related Links

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

MeSH Terms

Conditions

Patient Participation

Interventions

Heart Rate

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Pether Jildenstål, Assoc. Prof.

  Lund University

  STUDY DIRECTOR

Central Study Contacts

Camilla Viseu, MMedSci

CONTACT

+46705425698; camilla.viseu@med.lu.se

Carina Sjöberg, Phd

CONTACT

+46703636917; carina.sjoberg@med.lu.se

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 21, 2024
• Study Start: November 5, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 10, 2026
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)