Evaluation of a Music and Interaction Intervention on Patient Distress During Whole Body Magnetic Resonance

Recruiting

• Conditions: Neoplasm Malignant
• Interventions: Other: Experimental Group; Other: Control Group

• Registration Number: NCT06332001
• Lead Sponsor: European Institute of Oncology

Brief 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.

Detailed 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 Timeline

• Study Start: 2020-12-31
• Status Verified: 2024-03
• Study First Submitted: 2024-03-18
• Study First Submitted QC: 2024-03-25
• Last Update Submitted: 2024-03-25
• Study First Posted: 2024-03-26
• Last Update Posted: 2024-03-26
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Subjects who will undergo to WB-MRI for detection, staging, therapy monitoring or screening.
• Acceptance and signature of informed consent.

Exclusion Criteria

• Any contra-indication to MRI examination (for example, pacemaker, in the first trimester of pregnancy, metal implants, etc.).
• Anxiety disorder and psychological or pharmacological treatments for anxiety

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental Group	Experimental Group	Patients in this group receive the music and interaction interventions
Control Group	Control Group	Patients in this group receive a standard care condition (no music)

Primary Outcome Measures

Name	Time	Method
Acceptability of WB-MRI based on music and comunication intervention compared to a standard care condition.	1 week	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

Secondary Outcome Measures

Name	Time	Method
Measure the level of patient's distress pre and post WB-MRI in the two groups using Distress Thermometer (V2.2020)	1 week	Patients randomized in both groups will complete Distress Thermometer (Version 2.2020) to assess the level of distress before and after the procedure

Trial Locations

Locations (1)

IEO Istituto Europeo di Oncologia; 🇮🇹 Milan, Italy