Patient Anxiety During Magnetic Resonance Imaging
ConditionCancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEuropean Institute of Oncology
About this trial
This study is a cross-sectional validation project that aims to translate the MRI-Anxiety Questionnaire (MRI-AQ) into Italian and adapt it culturally for cancer patients undergoing whole-body MRI. The protocol will recruit 175 adult patients at the European Institute of Oncology, use a forward-backward translation process, and evaluate the Italian version with the MRI-AQ itself plus the MRI Fear Survey Schedule (MRI-FSS). The main statistical goal is to show that the Italian version is not inferior to the original in terms of internal consistency. The ultimate purpose is to provide a specific, validated tool for measuring MRI-related anxiety in Italian oncology patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Cancer patients who will perform a WB-MRI in their clinical path
Age ≥ 18 years
Patients able to speak and read the local language(s) fluently.
Patients with no concomitant neurological or psychiatric disorders.
Disqualifiers
Absolute contraindication to WB-MRI
Previous cancer-related medical treatments or other treatments that could have altered patients' cognition
Trial population
Oncology patients whose clinical course includes a WB-MRI
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Italian validation of the Magnetic Resonance Imaging-Anxiety Questionnaire (MRI-AQ)
Internal consistency of the Italian version of the MRI-AQ, evaluated by Cronbach's alpha to determine whether the translated instrument demonstrates psychometric reliability comparable to that of the original questionnaire.
Time frame
baselineSecondary outcomes
1
Magnetic Resonance Imaging Fear Survey Schedule (MRI-FSS)
To assess the construct validity of the MRI-FSS and to evaluate the feasibility and acceptability of the questionnaire in cancer patients undergoing whole-body MRI.
Time frame
baseline2
Feasibility and acceptability of the Italian MRI-AQ
Feasibility and acceptability of the Italian MRI-AQ, in cancer patients undergoing whole-body MRI.
Time frame
baseline3
MRI-related anxiety symptoms
Pattern and severity of MRI-related anxiety symptoms reported by participants during the imaging procedure.
Time frame
baselineSponsors and contacts
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Source ClinicalTrials.gov