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

NCT06332001 | Recruiting

• 1 other identifier: IEO 1403
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasm Malignant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Measure the level of patient's distress pre and post WB-MRI in the two groups using Distress Thermometer (V2.2020)

  1 week

Study Arms (2)

Experimental Group

Patients in this group receive the music and interaction interventions

Other: Experimental Group

Control Group

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

Other: Control Group

Interventions

Experimental Group OTHER

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

Experimental Group

Control Group OTHER

Standard care condition during WB-MRI

Control Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Subjects who will undergo to WB-MRI for detection, staging, therapy monitoring or screening.
• Acceptance and signature of informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

IEO Istituto Europeo di Oncologia

Milan, 20141, Italy

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Giuseppe Petralia

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppe Petralia, MD

CONTACT

+39 02 57489915; giuseppe.petralia@ieo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 26, 2024
• Study Start: December 31, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 26, 2024

Record last verified: 2024-03

Locations

IT (1)