- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06322264
Promoting Children's Participation in Conventional X-ray Examinations
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Camilla Viseu, MMedSci
- Phone Number: +46705425698
- Email: camilla.viseu@med.lu.se
Study Contact Backup
- Name: Carina Sjöberg, Phd
- Phone Number: +46703636917
- Email: carina.sjoberg@med.lu.se
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
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.
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pediatric patients
Pediatric patients between the ages of 4 and 12 undergoing conventional X-ray examinations.
|
The children will be given a portable device that will monitor their heart rate, enabling the recording of the rate of their pulse.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Pether Jildenstål, Assoc. Prof., Lund University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2023-05435-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Patient Participation
-
Wolfson Medical CenterRecruiting
-
Yale UniversityFood and Drug Administration (FDA)CompletedPatient ParticipationUnited States
-
NHS GrampianNot yet recruitingPatient Participation
-
GuerbetNot yet recruiting
-
Aversi ClinicUnknownPatient ParticipationGeorgia
-
Columbia UniversityMedical University of South Carolina; Northwestern UniversityCompleted
-
Assistance Publique - Hôpitaux de ParisUniversità degli Studi di Trento; Institut National de Recherche en Informatique... and other collaboratorsRecruitingPatient Participation | Professional Role | Patient Relations, NurseFrance
-
Radboud University Medical CenterJeroen Bosch ZiekenhuisUnknownCommunication | Patient ParticipationNetherlands
-
Pamukkale UniversityAkdeniz UniversityCompletedChild, Only | Participation, PatientTurkey
-
University Hospital, GhentUniversity GhentCompletedPatient Participation | Nursing | Bedside Shift ReportBelgium
Clinical Trials on Measurement of variation in heart rate
-
Bahçeşehir UniversityCompletedLong Covid19 | Autonomic DysfunctionTurkey
-
University Hospital OstravaCompletedMajor Abdominal SurgeryCzech Republic
-
Czech Technical University in PragueRecruiting
-
Zurich University of Applied SciencesUnknown
-
Czech Technical University in PragueRecruitingBlood Pressure | Heart RateCzechia
-
Leiden University Medical CenterCompletedBlood Coagulation Disorder
-
Central Hospital, Nancy, FranceNot yet recruiting
-
Hillel Yaffe Medical CenterUnknown
-
Quantiq.ioNot yet recruitingAnyone Who Meets the Eligibility Criteria Can Use the Software
-
PulseOn OyTAYS Sydänkeskus Oy; Atostek OyCompleted