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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06332001
Enrollment
200
Registered
2024-03-26
Start date
2020-12-31
Completion date
2024-12-31
Last updated
2024-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasm Malignant

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.

Interventions

OTHERControl Group

Standard care condition during WB-MRI

OTHERExperimental Group

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

Sponsors

European Institute of Oncology
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Acceptability of WB-MRI based on music and comunication intervention compared to a standard care condition.1 weekAcceptability 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

Secondary

MeasureTime frameDescription
Measure the level of patient's distress pre and post WB-MRI in the two groups using Distress Thermometer (V2.2020)1 weekPatients randomized in both groups will complete Distress Thermometer (Version 2.2020) to assess the level of distress before and after the procedure

Countries

Italy

Contacts

Primary ContactGiuseppe Petralia, MD
giuseppe.petralia@ieo.it+39 02 57489915

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 3, 2026