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Clinical Trial Summary

This is a randomized controlled trial for the evaluation of the acceptability of Whole-Body-Magnetic Resonance Imaging (WB-MRI) based on music and comunication intervention compared to a standard care condition. Subjects will be randomized into two groups: the experimental group or arm that receives the music and interaction interventions, and the control group or arm that receives a standard care condition.


Clinical Trial Description

This study is a randomized controlled trial. Subjects referring to the European Institute of Oncology (IEO) and will undergo to WB-MRI for detection, staging, therapy monitoring or screening, will be asked to participate to the study and signed the informed consent. Subjects will be divide into two groups: the experimental group or arm that receives the music and interaction interventions, and the control group or arm that receives a standard care condition. The experimental group before the WB-MRI examination, complete distress Thermometer and received verbal information about the procedure from one of TRSM trained, during the examination subjects he has the opportunity to listen to the music of his choice and TRSM interacts with the subject four times to know he feels well. Before the examination control group complete distress Thermometer. After examination both groups will be asked to complete a different WB-MRI acceptability questionnaire and distress Thermometer. WB-MRI acceptability questionnaire is ad hoc questionnaire create to evaluate the acceptability of the WB-MRI based on of the interventions carried out. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06332001
Study type Observational
Source European Institute of Oncology
Contact Giuseppe Petralia, MD
Phone +39 02 57489915
Email giuseppe.petralia@ieo.it
Status Recruiting
Phase
Start date December 31, 2020
Completion date December 31, 2024

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