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CancerMRI-AQNCT07671846

Patient Anxiety During Magnetic Resonance Imaging

An observational study of Cancer, run by European Institute of Oncology at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
How many people
175 participants
Where
1 siteItaly
Study dates
6 May 2026to 28 Feb 2027
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Oncology patients whose clinical course includes a WB-MRI

Who may be able to join

  • 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.
  • Acceptance and signature of informed consent

Who cannot join

  • Absolute contraindication to WB-MRI
  • Previous cancer-related medical treatments or other treatments that could have altered patients' cognition

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Giuseppe Petralia, PhD contact

+39 0257489037

giuseppe.petralia@ieo.it

Italy1 site, 1 recruiting
  • European Institute of Oncology, Milan

    Milan, Mi, 20141

    Lorenzo Conti, Researcher, +39 0294371083, Lorenzo.Conti@ieo.it

    Giusppe Petralia, PhD

    Recruiting

Other trials in Italy

About this study

Official title: Italian Translation and Cross-cultural Validation of a Questionnaire Evaluating Patient Anxiety During Magnetic Resonance Imaging: the Magnetic Resonance Imaging-Anxiety Questionnaire (MRI-AQ)

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.

Read the detailed description

Whole-body magnetic resonance imaging (WB-MRI) represents an advanced, radiation-free imaging technique that enables comprehensive evaluation of the entire body. Its application is well established in oncological practice, supported by international guidelines for the assessment of various malignancies. WB-MRI is particularly effective in detecting both bone and soft tissue lesions, providing accurate tumor staging and supporting optimal therapeutic monitoring. Although WB-MRI is a non-invasive and painless procedure, adequate patient preparation is essential to ensure its acceptability and smooth integration into the clinical workflow. Several psychological factors may influence patient acceptance of WB-MRI, potentially affecting the efficiency of the diagnostic process. Adult patients often experience significant anxiety, fear, or claustrophobia during the examination, sometimes requiring sedation. Evidence suggests that up to 37% of adults experience severe distress both before and during the WB-MRI scan. The main source of anxiety is usually the confinement in a narrow space for extended periods; however, additional stressors such as worry about the diagnostic outcome, loud scanner noise, vibrations, environmental isolation, and immobilization may further exacerbate patient discomfort and increase anxiety.

These inconveniences may lead up to 5% of patients to prematurely interrupt scanning. Furthermore, post-scan anxiety can contribute to the development of MRI-related fear or long-term phobia. Even when scanning is completed, coping with high levels of distress may result in motion that compromises image quality and reduces diagnostic accuracy.

From a psychological assessment perspective, a precise characterization of MRI-related anxiety is also crucial for clarifying its underlying dimensions and for evaluating change following targeted interventions. To gain a deeper understanding of the specific psychological responses elicited during MRI and to design psychometrically robust interventions aimed at reducing distress, a dedicated instrument that accurately measures MRI-related anxiety is required. A review of the existing literature indicates that the questionnaires previously used in MRI contexts are largely adaptations of general anxiety assessment tools that were originally developed to capture broad state-trait anxiety or hospital-related distress, such as the State-Trait Anxiety Inventory and the Hospital Anxiety and Depression Scale. To fill this gap in context-specific assessment, a new tailored questionnaire was developed by Ahlander and colleagues, capable of capturing the unique situational and environmental factors contributing to anxiety during MRI procedures, and of establishing its reliability, validity, and sensitivity to change in this particular setting. However, this instrument has so far been translated and validated only in a limited number of populations (e.g., English- and Swedish-speaking samples), and has not yet undergone a rigorous linguistic and cultural adaptation for Italian users. As a result, the Italian population still lacks a context-specific measure for assessing anxiety related to magnetic resonance imaging, leaving clinicians and researchers without an adequate tool for evaluating MRI-related anxiety in this setting.

Conditions
Cancer
Keywords
Magnetic Resonance Imaging, Patient anxiety
Medical subject headings
Neoplasms

What is being measured

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

  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.

    Measured: baseline

Secondary outcomes (3)
  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.

    Measured: baseline

  2. Feasibility and acceptability of the Italian MRI-AQ

    Feasibility and acceptability of the Italian MRI-AQ, in cancer patients undergoing whole-body MRI.

    Measured: baseline

  3. MRI-related anxiety symptoms

    Pattern and severity of MRI-related anxiety symptoms reported by participants during the imaging procedure.

    Measured: baseline

Timeline

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

  1. First posted26 Jun 2026
  2. Study start6 May 2026
  3. Primary completionFeb 2027 (estimated)
  4. Study completion28 Feb 2027 (estimated)

Resources

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
Other
Time perspective
Prospective
Enrolment
175 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07671846
Sponsor's protocol ID
UID 5337
Other IDs
L2-588
Acronym
MRI-AQ
Status last verified
May 2026
First submitted
15 Jun 2026
Last updated
26 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer, run by European Institute of Oncology at 1 site in Italy.

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 5 inclusion and 2 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 26 Jun 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 Italy. 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 Giuseppe Petralia, PhD (+39 0257489037, giuseppe.petralia@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Italian validation of the Magnetic Resonance Imaging-Anxiety Questionnaire (MRI-AQ) (time frame: baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 26 Jun 2026.

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