Clinical trial NCT06332001: Evaluation of a Music and Interaction Intervention on Patient Distress During Whole Body Magnetic Resonance
Official title: Evaluation of a Music and Interaction Intervention on Patient Distress During Whole Body Magnetic Resonance
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neoplasm Malignant
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Acceptability of WB-MRI based on music and comunication intervention compared to a standard care condition.
timeFrame: 1 week
Secondary outcomes:
measure: Measure the level of patient's distress pre and post WB-MRI in the two groups using Distress Thermometer (V2.2020)
timeFrame: 1 week
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IEO Istituto Europeo di Oncologia
Study officials:
affiliation: European Institute of Oncology
name: Giuseppe Petralia
role: PRINCIPAL_INVESTIGATOR
References: