An interventional study of Information leaflet and Educational movie in Headache, Urinary Incontinence and Growth Deficiency, sponsored by Children's Memorial Health Institute, Poland. Status unknown at 1 site in Poland. Open to participants aged 10 Years to 14 Years. Per ClinicalTrials.gov, last updated 2022-01-20.
Sponsored by Children's Memorial Health Institute, Poland · Not applicable, Interventional, and Other
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.
The aims of the trial
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.
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:
762 studies on the registry are indexed under Headache; 134 are open to participants now.
This study's planned enrollment of 300 is above the median of 65 across 560 interventional studies indexed under Headache.
Browse Headache studies →Children's Memorial Health Institute, Poland is the lead sponsor of 14 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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?"
Other: Information leaflet
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?"
Other: Educational movie
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".
Other: Demonstration
Study participant will obtain standard information about magnetic resonance imaging before examination.
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?"
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?"
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"
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
Time frame: through study completion, an average of 1 year
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
Time frame: through study completion, an average of 1 year
Patient's experience questionaire
Questionaire which assesses patient's experience during Magnetic Resonance examination; minimum score=0, maximum score=10, higher scores mean a better outcome
Time frame: through study completion, an average of 1 year
Patient's caregiver/parent experience questionaire
Questionaire which assesses patient's caregiver experience during MR examination; minimum score=0, maximum score=10, higher scores mean a better outcome
Time frame: through study completion, an average of 1 year
Patient's and caregiver's co-operation during the MR examination questionaire
Questionnaire which assesses the level of co-operation with the patient and their caregiver; minimum score=0, maximum score=10, higher scores mean a better outcome; as well as the occurrence of certain phenomena such as the need for additional sequences or the need to interrupt the examination: no / yes, yes is a worse outcome (to be completed by the technician)
Time frame: through study completion, an average of 1 year
Plan to share: No
Started Oct 2021 (actual). Primary completion is estimated for Oct 2022, 12 months after the start.
Of 175 non-industry interventional studies with no phase under Headache, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 37. This study's planned 12 months is below that.
Counting every sponsor, half of 193 studies reached it within 14 months; a quarter within 6 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Children's Memorial Health Institute, Poland