Neoplasm MalignantNCT06332001
Evaluation of a Music and Interaction Intervention on Patient Distress During Whole Body Magnetic Resonance
An observational study of Neoplasm Malignant, run by European Institute of Oncology at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neoplasm Malignant
- What is being tested?
- Experimental Group
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 31 Dec 2020to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects refferring to the European Institute of Oncology (IEO) and will undergo to WB-MRI for detection, staging, therapy monitoring or screening
Who may be able to join
- Subjects who will undergo to WB-MRI for detection, staging, therapy monitoring or screening.
- Acceptance and signature of informed consent.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IEO Istituto Europeo di Oncologia
Milan, 20141
Giuseppe Petralia, giuseppe.petralia@ieo.it
About this study
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.
Read the 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
- Being tested
- Experimental Group, Control Group
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental GroupOther
Listening of music of patient's choice during WB-MRI
Control GroupOther
Standard care condition during WB-MRI
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Patients in this group receive the music and interaction interventions Receives: Other: Experimental Group | |
| Control Group | Patients in this group receive a standard care condition (no music) Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Patients randomized in both groups will complete Distress Thermometer (Version 2.2020) to assess the level of distress before and after the procedure
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start31 Dec 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neoplasm MalignantStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Petralia, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332001
- Sponsor's protocol ID
- IEO 1403
- Status last verified
- Mar 2024
- First submitted
- 18 Mar 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Conti L, Summers P, Mainetti M, Gandini S, Fodor C, Petralia G, Pravettoni G. Evaluation of audiovisual and auditory interventions on exam anxiety during whole-body magnetic resonance imaging in cancer patients: a quasi-experimental study. Cancer Imaging. 2026 Jul 1. doi: 10.1186/s40644-026-01060-6. Online ahead of print.
PubMed 42387617
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Music and Interaction Intervention on Patient Distress During Whole Body Magnetic Resonance
- ClinicalTrials.gov ID
- NCT06332001
- Acronym / sponsor ID
- IEO 1403
- Conditions
- Neoplasm Malignant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 31 Dec 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | – | Other: Experimental GroupPatients in this group receive the music and interaction interventions |
| Control Group | – | Other: Control GroupPatients in this group receive a standard care condition (no music) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects refferring to the European Institute of Oncology (IEO) and will undergo to WB-MRI for detection, staging, therapy monitoring or screening
Key inclusion criteria (2 listed)
- Subjects who will undergo to WB-MRI for detection, staging, therapy monitoring or screening.
- Acceptance and signature of informed consent.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental GroupListening of music of patient's choice during WB-MRI | Other | Experimental Group |
| Control GroupStandard care condition during WB-MRI | Other | Control Group |
Primary outcome
Acceptability of WB-MRI based on music and comunication intervention compared to a standard care condition.
Time frame: 1 week
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 secondary outcome
Measure the level of patient's distress pre and post WB-MRI in the two groups using Distress Thermometer (V2.2020)
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Derived from this study: PubMed 42387617Conti L, Summers P, Mainetti M, Gandini S, Fodor C, Petralia G, Pravettoni G. Evaluation of audiovisual and auditory interventions on exam anxiety during whole-body magnetic resonance imaging in cancer patients: a quasi-experimental study. Cancer Imaging. 2026 Jul 1. doi: 10.1186/s40644-026-01060-6. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Petralia principal investigator
European Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasm Malignant, run by European Institute of Oncology at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Petralia, MD (+39 02 57489915, giuseppe.petralia@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of WB-MRI based on music and comunication intervention compared to a standard care condition. (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06332001, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.