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

Neoplasm Malignant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06332001
• Other study ID #: IEO 1403
• Status: Recruiting
• Start date: December 31, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: European Institute of Oncology
• Contact: Giuseppe Petralia, MD
• Phone: +39 02 57489915
• Email: giuseppe.petralia[@]ieo.it
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasm Malignant
• Neoplasms

Intervention

Other:
• Experimental Group
Listening of music of patient's choice during WB-MRI
• Control Group
Standard care condition during WB-MRI

Locations

Country	Name	City	State
Italy	IEO Istituto Europeo di Oncologia	Milan

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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