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HeadacheNCT05199363

Pediatric Patient Experience on a Diagnostic Path

A study testing Information leaflet, Educational movie and Demonstration in people with Headache and Urinary Incontinence, run by Children's Memorial Health Institute, Poland at 1 site in Poland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The trial will determine the impact of an information- and education-focused interventions on the anxiety levels, and patients' experiences as well as satisfaction of patients aged 10-14 and their caregivers during the MR examination. Read more about this study

Who is it for?
Ages 10 to 14 years
Conditions the study is for
Headache, Urinary Incontinence, Growth Deficiency
What is being tested?
Information leaflet, Educational movie and Demonstration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 sitePoland
Study dates
15 Oct 2021to 15 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

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 10 to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Patients aged 10-14 years.
  • Referred for magnetic resonance imaging due to clinical indications.
  • Patients undergoing magnetic resonance examination for the first time.
  • Possibility of cooperating with the patient during the examination, no need for sedation.
  • Consent of the patients' caregivers to participate in the examination; in the case of patients ≥ 13 years of age, also the patients' consents.
  • Absence of contraindications to magnetic resonance imaging

Who cannot join

  • Lack of parental or patient consent to participate in the trial.
  • Contraindications to undergo magnetic resonance imaging.
  • Lack of possibility to cooperate with the patient during the examination and/or the need for general anaesthesia for the MR examination.

Trial locations and contacts

1 site in 1 country.

Elżbieta Jurkiewicz, MD, PhD contact

+48 22 815 1276

e.jurkiewicz@ipczd.pl

Zbigniew Kułaga, MD, PhD contact

+48 603547517

z.kulaga@ipczd.pl

Poland1 site, 1 recruiting
  • Children Memorial Health Institute (CMHI)

    Warsaw, 04-730

    Elżbieta Jurkiewicz, MD, PhD, +48 22 815 1276, e.jurkiewicz@ipczd.pl

    Zbigniew Kułaga, MD, PhD, 603547517, z.kulaga@ipczd.pl

    Recruiting

Other trials in Poland

About this study

The trial will determine the impact of an information- and education-focused interventions on the anxiety levels, and patients' experiences as well as satisfaction of patients aged 10-14 and their caregivers during the MR examination.

Read the detailed description

The aims of the trial

  1. Examining the level of anxiety of individuals undergoing magnetic resonance imaging (MRI) as patients or caregivers (anxiety is measured at two points: before and after the MRI procedure).
  2. Examining subjective patients' and caregivers' assessments of the key factors which make up the Patient Experience, i.e. the sum of all interactions which influence perceptions of the patients and their caregivers. The Patient Experience in this sense includes what is perceived, understood and remembered by the patient and their relatives in terms of:
  • access to services and resources
  • coordination and safety
  • effectiveness of the services
  • communication and education
  • patient empowerment
  • respect and dignity
  • ensuring physical wellbeing
  • ensuring psychological wellbeing
  • environment and comfort and consequent levels of satisfaction. The full set of factors will only be examined for the patients' caregivers, while for the patients themselves the set of factors will be limited to those which can be competently assessed by persons aged 10-14 years.
  1. Examining the extent to which education- and information-focused interventions, using a variety of media (information leaflets, educational video, demonstration with props), impact anxiety levels, individual elements of the experience, and patients' and caregivers' satisfaction levels.
  2. Examining the extent to which educational- and informational-focused interventions can increase patients' co-operation and thus contribute to shorter examination times (avoidance of repetition of sequences) and a reduction in the rate of interrupted examinations.
  3. The participants will be recruited by the registration staff of the Magnetic Resonance (MR) Laboratory from those enrolled for magnetic resonance examinations for clinical indications. It will be done during a routine reminder of the upcoming examination date. The staff member informs the patient's caregiver of a possibility to participate in the examination and, after obtaining a preliminary declaration of participation, of the necessity to arrive 1 hour before the predetermined time.
  4. When the patient and their caregiver arrive at the Registration of the Magnetic Resonance Laboratory, a registration staff member hands over the "Information on the Trial regarding the Paediatric Patient Experience on the Diagnostic Pathway" which contains details of the objectives, design, scope and duration of the procedures and inconvenience of the trial which will be conducted, the expected benefits to participants of the trial which is a research experiment, and the health risks and hazards for the participants, the arrangements regarding handling any adverse events, the measures undertaken to ensure respect for the participants' privacy and the confidentiality of their personal data, and the rules for access to relevant information concerning the participants obtained during implementation of the experiment and the overall results thereof and for further use of the results thereof. The investigator also informs the participants of the possibility of withdrawing from the trial at any stage, of the rules on compensation in the event of any harm and of the source of funding of the medical experiment. After answering any questions from the subject, the investigator collects a signed Informed Consent Form from both the caregiver and the child, together with the information about the trial attached to it.
  5. A staff member of the Registration of the Magnetic Resonance Laboratory draws an allocation to one of the Groups (A/B/C/D) from a pool of sealed envelopes together with a unique code for the trial and enters the code into all questionnaires used in the trial.
  6. An radiology technologist or psychologist (after receiving training in the objectives, protocol and tools of the trial) provides the interventions as they are appropriate to groups:
  • to Group A: the investigator gives the information leaflet "Information for young patients and their caregivers. What is MRI and what is the examination like?" and ensures that the patient and caregiver read it.
  • to Group B: the investigator plays the educational video "What is an MRI and what is the examination like?" to the patient and caregiver and ensures that the patient and caregiver familiarise themselves with it.
  • to Group C: the investigator conducts a scenario-based demonstration using props in the form of a model scanner and a multimedia presentation ("Scenario for demonstration before a magnetic resonance examination for young patients and their caregivers")." No intervention is carried out in Group D.
  1. The patient's caregiver completes the State-Trait Anxiety Inventory (STAI) questionnaire.
  2. The patient (assisted by a technician or psychologist) completes the State-Trait Anxiety Inventory for Children (STAIC) form.
  3. A standard process of preparing for the magnetic resonance examination by a technician follows, and the magnetic resonance examination is performed as clinically indicated.
  4. The technician completes the questionnaire entitled "Assessment of the patient's and their caregiver's cooperation during magnetic resonance examination".
  5. The caregiver again completes the State-Trait Anxiety Inventory (STAI) questionnaire.
  6. The patient's caregiver completes the questionnaire "Assessment of the experience of the patient's caregiver during magnetic resonance examination".
  7. The patient (assisted by a technician or psychologist) again fills in the "State-Trait Anxiety Inventory for Children (STAIC) questionnaire.
  8. The patient (assisted by a technician or psychologist) fills in the questionnaire "Evaluation of the patient's experience during the magnetic resonance examination".
Being tested
Information leaflet, Educational movie, Demonstration
Keywords
child, magnetic resonance imaging, anxiety, patient experience
Medical subject headings
Headache, Urinary Incontinence, Vision Disorders, Psychomotor Disorders, Demyelinating Diseases, Brain Neoplasms, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Information leafletOther

    Before examination study participant will obtain an information leaflet which includes descriptive and illustrative sections "Information for young patients and their caregivers. What is Magnetic Resonance Imaging and what is the examination like?"

  • Educational movieOther

    Before examination study participant will be shown educational video with an radiology technologist and actors who role play the examination "What is MRI and what is the examination like?"

  • DemonstrationOther

    Before examination study participant will take a part in scenario-based demonstration with the use of props such as the scanner model and a multimedia presentation "Scenario for a demonstration before a Magnetic Resonance examination for young patients and their caregivers"

Study groups in NCT05199363
Study groupRoleWhat they receive
Information leafletActive comparatorBefore examination study participant will obtain an information leaflet which includes descriptive and illustrative sections "Information for young patients and their caregivers. What is Magnetic Resonance Imaging and what is the examination like?"
Receives: Other: Information leaflet
Educational movieActive comparatorBefore examination study participant will be shown educational video with an radiology technologist and actors who role play the examination "What is MRI and what is the examination like?"
Receives: Other: Educational movie
DemonstrationActive comparatorBefore examination study participant will take a part in scenario-based demonstration with the use of props such as the scanner model and a multimedia presentation "Scenario for a demonstration before a Magnetic Resonance examination for young patients and their caregivers".
Receives: Other: Demonstration
ControlNo interventionStudy participant will obtain standard information about magnetic resonance imaging before examination.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. State-Trait Anxiety Inventory for Children

    Change in State-Trait Anxiety Inventory for Children score; minimum score=20, maximum score=60, higher scores mean a worse outcome

    Measured: through study completion, an average of 1 year

Secondary outcomes (1)
  1. State-Trait Anxiety Inventory

    Change in parent's State-Trait Anxiety Inventory score; minimum score=20, maximum score=80, higher scores mean a worse outcome

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2022
  2. Study start15 Oct 2021
  3. Primary completion15 Oct 2022 (estimated)
  4. Study completion15 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Study participants will be randomly assigned into one of 4 groups: * Group A, 25% of the sample - patients subject to intervention No 1: "Information leaflet" * Group B, 25% of the sample - patients subject to intervention No. 2: "Educational movie" * Group C, 25% of the sample - patients subject to intervention No. 3 "Demonstration" * Group D, 25% of the sample - control group, with no intervention.
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05199363
Sponsor's protocol ID
Nr510/2021_ChildrensMHIPoland
Status last verified
Jan 2022
First submitted
28 Dec 2021
Last updated
20 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Makanjee CR, Bergh AM, Hoffmann WA. Healthcare provider and patient perspectives on diagnostic imaging investigations. Afr J Prim Health Care Fam Med. 2015 May 20;7(1):801. doi: 10.4102/phcfm.v7i1.801.

    PubMed 26245604
  • Carlsson S, Carlsson E. 'The situation and the uncertainty about the coming result scared me but interaction with the radiographers helped me through': a qualitative study on patients' experiences of magnetic resonance imaging examinations. J Clin Nurs. 2013 Nov;22(21-22):3225-34. doi: 10.1111/jocn.12416.

    PubMed 24118524
  • Munn Z, Pearson A, Jordan Z, Murphy F, Pilkington D, Anderson A. Addressing the Patient Experience in a Magnetic Resonance Imaging Department: Final Results from an Action Research Study. J Med Imaging Radiat Sci. 2016 Dec;47(4):329-336. doi: 10.1016/j.jmir.2016.04.007. Epub 2016 Jun 27.

    PubMed 31047258
  • Bolderston A. Patient Experience in Medical Imaging and Radiation Therapy. J Med Imaging Radiat Sci. 2016 Dec;47(4):356-361. doi: 10.1016/j.jmir.2016.09.002. Epub 2016 Oct 15.

    PubMed 31047261
  • Jensen JD, Allen L, Blasko R, Nagy P. Using Quality Improvement Methods to Improve Patient Experience. J Am Coll Radiol. 2016 Dec;13(12 Pt B):1550-1554. doi: 10.1016/j.jacr.2016.09.005.

    PubMed 27888940

Questions about this trial

What is this clinical trial studying?

A study testing Information leaflet, Educational movie and Demonstration in people with Headache and Urinary Incontinence, run by Children's Memorial Health Institute, Poland at 1 site in Poland.

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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 20 Jan 2022. 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 Poland. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Elżbieta Jurkiewicz, MD, PhD (+48 22 815 1276, e.jurkiewicz@ipczd.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

State-Trait Anxiety Inventory for Children (time frame: through study completion, an average of 1 year). 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 NCT05199363, which also lists 5 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 20 Jan 2022.

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