Patient Anxiety During Magnetic Resonance Imaging
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Cancer. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Италия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Italian Translation and Cross-cultural Validation of a Questionnaire Evaluating Patient Anxiety During Magnetic Resonance Imaging: the Magnetic Resonance Imaging-Anxiety Questionnaire (MRI-AQ)
Обзор
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.
Подробное описание
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.
Первичные конечные точки
- Italian validation of the Magnetic Resonance Imaging-Anxiety Questionnaire (MRI-AQ) [Срок оценки: baseline]
Вторичные конечные точки (3)
- Magnetic Resonance Imaging Fear Survey Schedule (MRI-FSS) [Срок оценки: baseline]
- Feasibility and acceptability of the Italian MRI-AQ [Срок оценки: baseline]
- MRI-related anxiety symptoms [Срок оценки: baseline]
Критерии участия
Критерии включения
- 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
Критерии исключения
- Absolute contraindication to WB-MRI
- Previous cancer-related medical treatments or other treatments that could have altered patients' cognition
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Другое
Центры проведения
Италия · 1 центр
- European Institute of Oncology, Milan — Milan
Идентификаторы
NCT: NCT07671846 · UID 5337 · L2-588