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

NCT ID: NCT06332001

Last Updated: 2024-03-26

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-31
• Study Completion Date: 2024-12-31

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.

Conditions

Neoplasm Malignant

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Experimental Group

Patients in this group receive the music and interaction interventions

Experimental Group

Intervention Type: OTHER

Listening of music of patient's choice during WB-MRI

Control Group

Patients in this group receive a standard care condition (no music)

Control Group

Intervention Type: OTHER

Standard care condition during WB-MRI

Interventions

Experimental Group

Listening of music of patient's choice during WB-MRI

Intervention Type: OTHER

Control Group

Standard care condition during WB-MRI

Intervention Type: OTHER

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Institute of Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giuseppe Petralia

Role: PRINCIPAL_INVESTIGATOR

European Institute of Oncology

Locations

IEO Istituto Europeo di Oncologia

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Giuseppe Petralia, MD

Role: CONTACT

giuseppe.petralia@ieo.it

+39 02 57489915

Facility Contacts

Giuseppe Petralia

Role: primary

giuseppe.petralia@ieo.it

Other Identifiers

IEO 1403

Identifier Type: -

Identifier Source: org_study_id