Patient Anxiety During Magnetic Resonance Imaging

NCT07671846 | Recruiting

• 2 other identifiers: UID 5337L2-588
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cancer

Keywords

Magnetic Resonance Imaging; Patient anxiety

Outcome Measures

Primary Outcomes (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.

  baseline

Secondary Outcomes (3)

• Magnetic Resonance Imaging Fear Survey Schedule (MRI-FSS)

  baseline

• Feasibility and acceptability of the Italian MRI-AQ

  baseline

• MRI-related anxiety symptoms

  baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Oncology patients whose clinical course includes a WB-MRI

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology, Milan

Milan, Mi, 20141, Italy

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Giuseppe Petralia, PhD

CONTACT

+39 0257489037; giuseppe.petralia@ieo.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 26, 2026
• Study Start: May 6, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: June 26, 2026

Record last verified: 2026-05

Locations

IT (1)