Menu
Recruiting NCT07671846

Patient Anxiety During Magnetic Resonance Imaging

Observational Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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)

Overview

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.

Primary outcome measures

  • Italian validation of the Magnetic Resonance Imaging-Anxiety Questionnaire (MRI-AQ) [Time frame: baseline]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Italy · 1 center
  • European Institute of Oncology, Milan — Milan

Identifiers

NCT: NCT07671846 · UID 5337 · L2-588

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗