CancerMRI-AQNCT07671846
Patient Anxiety During Magnetic Resonance Imaging
An observational study of Cancer, run by European Institute of Oncology at 1 site in Italy.
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.
Italy1 site, 1 recruiting
- Recruiting
European Institute of Oncology, Milan
Milan, Mi, 20141
Lorenzo Conti, Researcher, +39 0294371083, Lorenzo.Conti@ieo.it
Giusppe Petralia, PhD
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.
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)
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
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
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.
- First posted26 Jun 2026
- Study start6 May 2026
- Primary completionFeb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07671846
- Acronym / sponsor ID
- MRI-AQ / UID 5337
- Conditions
- Cancer
- Keywords
- Magnetic Resonance Imaging, Patient anxiety
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 6 May 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 26 Jun 2026 (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.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Oncology patients whose clinical course includes a WB-MRI
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Absolute contraindication to WB-MRI
- Previous cancer-related medical treatments or other treatments that could have altered patients' cognition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Italian validation of the Magnetic Resonance Imaging-Anxiety Questionnaire (MRI-AQ)
Time frame: baseline
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.
3 secondary outcomes
Magnetic Resonance Imaging Fear Survey Schedule (MRI-FSS)
Time frame: baseline
Feasibility and acceptability of the Italian MRI-AQ
Time frame: baseline
MRI-related anxiety symptoms
Time frame: baseline
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 26 Jun 2026.
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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.
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 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.