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

European Institute of Oncology

Status: Enrolling

Conditions: Neoplasm Malignant

Treatments: Other: Experimental Group; Other: Control Group

Study type: Observational

Funder types: Other

Identifiers

NCT06332001

IEO 1403

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

Experimental Group

Description:

Patients in this group receive the music and interaction interventions

Treatment:

Other: Experimental Group

Control Group

Description:

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

Treatment:

Other: Control Group