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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Patients in this group receive the music and interaction interventions |
| |
| Control Group | Patients in this group receive a standard care condition (no music) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Group | Other | Listening of music of patient's choice during WB-MRI |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of WB-MRI based on music and comunication intervention compared to a standard care condition. | Acceptability of WB-MRI based on music and comunication intervention compared to a standard care condition. The evaluation of the acceptability of WB-MRI will be done in both groups using an ad hoc WB-MRI acceptability questionnaire created to evaluate the acceptability of the WB-MRI based on of the interventions carried out | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Measure the level of patient's distress pre and post WB-MRI in the two groups using Distress Thermometer (V2.2020) | Patients randomized in both groups will complete Distress Thermometer (Version 2.2020) to assess the level of distress before and after the procedure | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects refferring to the European Institute of Oncology (IEO) and will undergo to WB-MRI for detection, staging, therapy monitoring or screening
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giuseppe Petralia, MD | Contact | +39 02 57489915 | giuseppe.petralia@ieo.it |
| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Petralia | European Institute of Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IEO Istituto Europeo di Oncologia | Recruiting | Milan | 20141 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42387617 | Derived | Conti L, Summers P, Mainetti M, Gandini S, Fodor C, Petralia G, Pravettoni G. Evaluation of audiovisual and auditory interventions on exam anxiety during whole-body magnetic resonance imaging in cancer patients: a quasi-experimental study. Cancer Imaging. 2026 Jul 1. doi: 10.1186/s40644-026-01060-6. Online ahead of print. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Control Group |
| Other |
Standard care condition during WB-MRI |
|
| D008722 | Methods |