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

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.

Study Overview

• Status: Recruiting
• Conditions: Neoplasm Malignant
• Intervention / Treatment: Other: Experimental Group; Other: Control Group

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Giuseppe Petralia, MD; Phone Number: +39 02 57489915; Email: giuseppe.petralia@ieo.it

Study Locations

• Italy
  • Milan, Italy, 20141
    • Recruiting
    • IEO Istituto Europeo di Oncologia
    • Contact: Giuseppe Petralia; Email: giuseppe.petralia@ieo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Subjects refferring to the European Institute of Oncology (IEO) and will undergo to WB-MRI for detection, staging, therapy monitoring or screening

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Experimental Group; Patients in this group receive the music and interaction interventions	Other: Experimental Group; Listening of music of patient's choice during WB-MRI
Control Group; Patients in this group receive a standard care condition (no music)	Other: Control Group; Standard care condition during WB-MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: European Institute of Oncology
• Investigators: Principal Investigator: Giuseppe Petralia, European Institute of Oncology

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2020
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 18, 2024
• First Submitted That Met QC Criteria: March 25, 2024
• First Posted (Actual): March 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: IEO 1403

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No