Heart Rate DeterminationNCT06322264
Promoting Children's Participation in Conventional X-ray Examinations
An observational study of Heart Rate Determination and Patient Participation, run by Lund University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Heart Rate Determination, Patient Participation
- What is being tested?
- Measurement of variation in heart rate
- How many people
- 220 participants
- Where
- 1 siteSweden
- Study dates
- 5 Nov 2024to 10 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Children ages 4-12 yrs who undergo standard x-ray examinations
- parents to the child
- assigned radiographers
Who cannot join
- Children and parents who have cognitive and/or language difficulties
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
SUS
Lund, Skåne County, 221 00
Camilla Viseu, 0046-462220000, Camilla.viseu@med.lu.se
About this study
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.
Read the 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.
- Conditions
- Heart Rate Determination, Patient Participation
- Being tested
- Measurement of variation in heart rate
- Keywords
- Children's participation, Conventional x-ray procedure, Variation in heart rate
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of variation in heart rateDiagnostic test
The children will be given a portable device that will monitor their heart rate, enabling the recording of the rate of their pulse.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric patients | Pediatric patients between the ages of 4 and 12 undergoing conventional X-ray examinations. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in heart rate
To compare the variations in pulse with the experience of the examination
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start5 Nov 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion10 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart Rate DeterminationStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Skane University Hospital
- Responsible party
- Sponsor
- Investigators
- Pether Jildenstål, Assoc. Prof., Study director, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06322264
- Sponsor's protocol ID
- 2023-05435-01
- Other IDs
- 2023
- Status last verified
- Aug 2026
- First submitted
- 7 Mar 2024
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 12136815Sahlberg 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.
PubMed 32319716Gilljam 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.
PubMed 31531995
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Children's Participation in Conventional X-ray Examinations
- ClinicalTrials.gov ID
- NCT06322264
- Acronym / sponsor ID
- 2023-05435-01
- Conditions
- Heart Rate Determination, Patient Participation
- Keywords
- Children's participation, Conventional x-ray procedure, Variation in heart rate
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Skane University Hospital
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 10 Dec 2028 (estimated)
- First posted
- 21 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients | – | Diagnostic Test: Measurement of variation in heart ratePediatric patients between the ages of 4 and 12 undergoing conventional X-ray examinations. |
| 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. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- Children ages 4-12 yrs who undergo standard x-ray examinations
- parents to the child
- assigned radiographers
Key exclusion criteria (1 listed)
- Children and parents who have cognitive and/or language difficulties
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of variation in heart rateThe children will be given a portable device that will monitor their heart rate, enabling the recording of the rate of their pulse. | Diagnostic test | Pediatric patients |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Background: PubMed 12136815Hardy 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.
- Results publication: PubMed 32319716Sahlberg 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.
- Results publication: PubMed 31531995Gilljam 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.
- Almen, A., \& Jangland, L., (2020). Radiological examinations in Sweden in 2018 (Report 2020:14). The Radiation Safety Authority.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pether Jildenstål, Assoc. Prof. study director
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Rate Determination and Patient Participation, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Camilla Viseu, MMedSci (+46705425698, camilla.viseu@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06322264, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.