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NCT Number: NCT07671846

Patient Anxiety During Magnetic Resonance Imaging

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

European Institute of Oncology, Milan

Milan, Mi, 20141, Italy

Location status: Recruiting

Location contact

Giusppe Petralia, PhD

PRINCIPAL_INVESTIGATOR

Lorenzo Conti, Researcher

CONTACT

[email protected]

+39 0294371083

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Magnetic Resonance Imaging Fear Survey Schedule (MRI-FSS)

    Time frame: baseline

    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.

  2. Feasibility and acceptability of the Italian MRI-AQ

    Time frame: baseline

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

  3. MRI-related anxiety symptoms

    Time frame: baseline

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

Study contacts

Contact information is provided by the study sponsor or research team.

Giuseppe Petralia, PhD

CONTACT

[email protected]

+39 0257489037

Sponsors and collaborators

Lead sponsor

European Institute of Oncology

Other

Registry information

Official study 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)

Acronym: MRI-AQ

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 26, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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