Interventional RadiologyNCT05461482
CLINTERVENTIONAL Trial: Impact of Clinical Consultations and Audiovisual Tools in Interventional Radiology
A study testing Pre-procedural consultation and audiovisual tools in people with Interventional Radiology and Physician-Patient Relations, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
Trial summary
Objectives: To assess whether the implementation of pre-procedural consultations and the use of explanatory audiovisual tools prior to performing Vascular and Interventional Radiology procedures improve the understanding of interventions by patients, improve satisfaction with the information provided and reduce… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interventional Radiology, Physician-Patient Relations, Communication
- What is being tested?
- Pre-procedural consultation and audiovisual tools
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 428 participants
- Where
- 1 siteSpain
- Study dates
- 31 Aug 2022to Apr 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are going to undergo one of the following elective vascular interventional procedures: tunneled cuffed catheter placement, fistulography and endovascular treatment of hemodialysis arteriovenous fistulas, vascular recanalization procedures and vascular embolization procedures.
- Patients undergoing one of the following elective nonvascular interventional procedures: image-guided percutaneous biopsies, percutaneous fluid and abscess drainage, percutaneous transhepatic biliary drainage and percutaneous nephrostomy.
Who cannot join
- Patients under 18 years of age.
- Patients who require the participation of a third party for informed consent.
- Pregnant patients.
- Patients undergoing urgent interventional procedures.
- Patients with allergy or intolerance to mepivacaine, tramadol, midazolam or fentanyl.
- Patients who do not understand and speak Spanish properly.
- Patients with deafness or blindness.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Reina Sofia
Córdoba, 14004
Pedro Blas García Jurado, MD, 0034957010872, pedroblasgj@gmail.com
Ana Isabel Cerro, 0034957010872, ana.cerro@imibic.org
About this study
Official title: CLINTERVENTIONAL Trial: A Randomized Controlled Two-arm Trial to Evaluate the Impact of Clinical Consultations and Audiovisual Tools in Patients Who Are Going to Undergo Interventional Radiology Procedures.
- Objectives: To assess whether the implementation of pre-procedural consultations and the use of explanatory audiovisual tools prior to performing Vascular and Interventional Radiology procedures improve the understanding of interventions by patients, improve satisfaction with the information provided and reduce anxiety experienced by the procedure.
- Methods: We will conduct a two-arm randomized clinical trial that will include patients undergoing Vascular and Interventional Radiology procedures. After consent to participation by signing the informed consent, participants will be randomly assigned to the control group (patients to whom the information about the procedure is provided by the requesting physician) and to the experimental group (patients who, in addition to being informed by the requesting physicians, are attended by interventional radiologists in consultation after previously viewing explanatory videos of the interventions). Multi-choice questionnaires will be used to assess understanding and knowledge of the interventions and validated scales to measure satisfaction with the information provided and anxiety experienced. Knowledge and understanding of the intervention, satisfaction with the information transmitted and the method of transmission, as well as anxiety related to the intervention will be compared between the control group and the experimental group. The Student's t-test and the Mann-Whitney test will be used for the comparison of quantitative variables and the chi-square test and Fisher's exact test for the comparison of qualitative variables. Regression analysis will be used to evaluate associations between variables.
- Expected results: To demonstrate that the implementation of pre-procedural consultations attended by interventional radiologists and the use of educational audiovisual tools prior to performing Vascular and Interventional Radiology procedures improve the understanding of interventions by patients, their satisfaction with the information provided and reduces the anxiety experienced for the procedure.
- Potential impact: It is the first clinical trial that analyzes the usefulness of pre-procedural consultations and audiovisual tools in Vascular and Interventional Radiology, so its results will be very interesting to help standardize clinical practice in Vascular and Interventional Radiology.
- Conditions
- Interventional Radiology, Physician-Patient Relations, Communication, Physician's Practice Patterns, Patient Satisfaction
- Being tested
- Pre-procedural consultation and audiovisual tools
- Medical subject headings
- Communication, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-procedural consultation and audiovisual toolsOther
In addition to the information provided by the referring physician, an interventional radiologist will assist the patient in a consultation before the intervention to inform him, explaining the objective of the intervention, its risks and benefits, and possible alternatives and doubts related to the intervention. In this group, educational videos will be used, one for each type of intervention, which will complement the explanations of the physician. The videos will aim to present in an understandable way the preparation for the intervention, its objective, the benefits and risks that derive from it and what you can expect once it has been carried out. Patients will have access to the videos before attending the consultation and will view them before being seen by the interventional radiologist.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The physician requesting the intervention will be responsible for informing the patient, explaining the purpose of the intervention, its risks and benefits, and possible alternatives and doubts related to the intervention. |
| Experimental group | Experimental | In addition to the information provided by the referring physician, an interventional radiologist will assist the patient in a consultation before the intervention to inform him, explaining the objective of the intervention, its risks and benefits, and possible alternatives and doubts related to the intervention. In this group, educational videos will be used, one for each type of intervention, which will complement the explanations of the physician. The videos will aim to present in an understandable way the preparation for the intervention, its objective, the benefits and risks that derive from it and what you can expect once it has been carried out. Patients will have access to the videos before attending the consultation and will view them before being seen by the interventional radiologist. Receives: Other: Pre-procedural consultation and audiovisual tools |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knowledge from baseline to immediately preoperatively using a multi-choice questionnaire. Where the patient's knowledge was assessed related to the intervention.
It will be assessed if the preparation for the intervention, the indication, the intervention itself, the subsequent care and the benefits, risks and alternatives are known and understood. It will be analyzed using a multi-choice questionnaire.
Measured: From baseline at preoperative assessment to immediately preoperatively: 24 hours.
Change in Anxiety from baseline to immediately preoperatively using a Visual analogue scale (0-10) and State-Trait Anxiety Inventory (20-80).
It will be assessed if the preparation for the intervention, the indication, the intervention itself, the subsequent care and the benefits, risks and alternatives are known and understood. It will be analyzed using a multi-choice questionnaire.
Measured: From baseline at preoperative assessment to immediately preoperatively: 24 hours.
Change in satisfaction from baseline to immediately preoperatively using a Visual analogue scale (0-10).
It will be assessed if the preparation for the intervention, the indication, the intervention itself, the subsequent care and the benefits, risks and alternatives are known and understood. It will be analyzed using a multi-choice questionnaire.
Measured: From baseline at preoperative assessment to immediately preoperatively: 24 hours.
Secondary outcomes (2)
Assessment the association between all of variables through a descriptive analysis using SPSS.
It will be assessed the association between demographic variables, type of intervention, personal history, intervention group, anxiety related to the intervention, level of knowledge and understanding of the intervention, type of anesthesia, and degree of sedation with the pain intensity during the intervention, with the level of tolerance of the intervention and with the level of satisfaction with the intervention performed
Measured: Through study completion: 18 months
To contrast differences in the variables of both arms through a descriptive analysis using SPSS.
Comparative analysis of the duration of the intervention, the intensity of the pain perceived by the patient during the procedure, the level of tolerance of the intervention and the level of satisfaction with the intervention carried out in the two groups of patients.
Measured: Through study completion: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start31 Aug 2022
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Interventional RadiologyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 428 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pedro Blas García Jurado, MD, Principal investigator, Reina Sofia University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461482
- Sponsor's protocol ID
- Analisis RVI
- Status last verified
- Oct 2023
- First submitted
- 20 Apr 2022
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Garcia Jurado PB, Espejo Herrero JJ, Lombardo Galera MS, Perez Montilla ME, Barranco Acosta S, Garcia-Revillo Garcia J, Font Ugalde P, Alvarez Benito M. Impact of the clinical role of interventional radiologists: results of the CLINTERVENTIONAL randomized controlled trial. Eur Radiol. 2025 Dec;35(12):7658-7668. doi: 10.1007/s00330-025-11757-0. Epub 2025 Jun 17.
PubMed 40526354Garcia Jurado PB, Espejo Herrero JJ, Lombardo Galera MS, Perez Montilla ME, Barranco Acosta S, Garcia-Revillo J, Font Ugalde P, Alvarez Benito M. CLINTERVENTIONAL protocol: a randomized controlled trial to evaluate clinical consultations and audiovisual tools for interventional radiology. Eur Radiol Exp. 2025 Jan 15;9(1):6. doi: 10.1186/s41747-024-00545-y.
PubMed 39812733
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLINTERVENTIONAL Trial: A Randomized Controlled Two-arm Trial to Evaluate the Impact of Clinical Consultations and Audiovisual Tools in Patients Who Are Going to Undergo Interventional Radiology Procedures.
- ClinicalTrials.gov ID
- NCT05461482
- Acronym / sponsor ID
- Analisis RVI
- Conditions
- Interventional Radiology, Physician-Patient Relations, Communication, Physician's Practice Patterns, Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 428 participants (estimated)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 18 Jul 2022 (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.
- Objectives: To assess whether the implementation of pre-procedural consultations and the use of explanatory audiovisual tools prior to performing Vascular and Interventional Radiology procedures improve the understanding of interventions by patients, improve satisfaction with the information provided and reduce anxiety experienced by the procedure.
- Methods: We will conduct a two-arm randomized clinical trial that will include patients undergoing Vascular and Interventional Radiology procedures. After consent to participation by signing the informed consent, participants will be randomly assigned to the control group (patients to whom the information about the procedure is provided by the requesting physician) and to the experimental group (patients who, in addition to being informed by the requesting physicians, are attended by interventional radiologists in consultation after previously viewing explanatory videos of the interventions). Multi-choice questionnaires will be used to assess understanding and knowledge of the interventions and validated scales to measure satisfaction with the information provided and anxiety experienced. Knowledge and understanding of the intervention, satisfaction with the information transmitted and the method of transmission, as well as anxiety related to the intervention will be compared between the control group and the experimental group. The Student's t-test and the Mann-Whitney test will be used for the comparison of quantitative variables and the chi-square test and Fisher's exact test for the comparison of qualitative variables. Regression analysis will be used to evaluate associations between variables.
- Expected results: To demonstrate that the implementation of pre-procedural consultations attended by interventional radiologists and the use of educational audiovisual tools prior to performing Vascular and Interventional Radiology procedures improve the understanding of interventions by patients, their satisfaction with the information provided and reduces the anxiety experienced for the procedure.
- Potential impact: It is the first clinical trial that analyzes the usefulness of pre-procedural consultations and audiovisual tools in Vascular and Interventional Radiology, so its results will be very interesting to help standardize clinical practice in Vascular and Interventional Radiology.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The physician requesting the intervention will be responsible for informing the patient, explaining the purpose of the intervention, its risks and benefits, and possible alternatives and doubts related to the intervention. |
| Experimental group | Experimental | Other: Pre-procedural consultation and audiovisual toolsIn addition to the information provided by the referring physician, an interventional radiologist will assist the patient in a consultation before the intervention to inform him, explaining the objective of the intervention, its risks and benefits, and possible alternatives and doubts related to the intervention. In this group, educational videos will be used, one for each type of intervention, which will complement the explanations of the physician. The videos will aim to present in an understandable way the preparation for the intervention, its objective, the benefits and risks that derive from it and what you can expect once it has been carried out. Patients will have access to the videos before attending the consultation and will view them before being seen by the interventional radiologist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who are going to undergo one of the following elective vascular interventional procedures: tunneled cuffed catheter placement, fistulography and endovascular treatment of hemodialysis arteriovenous fistulas, vascular recanalization procedures and vascular embolization procedures.
- Patients undergoing one of the following elective nonvascular interventional procedures: image-guided percutaneous biopsies, percutaneous fluid and abscess drainage, percutaneous transhepatic biliary drainage and percutaneous nephrostomy.
Key exclusion criteria (7 listed)
- Patients under 18 years of age.
- Patients who require the participation of a third party for informed consent.
- Pregnant patients.
- Patients undergoing urgent interventional procedures.
- Patients with allergy or intolerance to mepivacaine, tramadol, midazolam or fentanyl.
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 |
|---|---|---|
| Pre-procedural consultation and audiovisual toolsIn addition to the information provided by the referring physician, an interventional radiologist will assist the patient in a consultation before the intervention to inform him, explaining the objective of the intervention, its risks and benefits, and possible alternatives and doubts related to the intervention. In this group, educational videos will be used, one for each type of intervention, which will complement the explanations of the physician. The videos will aim to present in an understandable way the preparation for the intervention, its objective, the benefits and risks that derive from it and what you can expect once it has been carried out. Patients will have access to the videos before attending the consultation and will view them before being seen by the interventional radiologist. | Other | Experimental group |
Primary outcome
Change in Knowledge from baseline to immediately preoperatively using a multi-choice questionnaire. Where the patient's knowledge was assessed related to the intervention.
Time frame: From baseline at preoperative assessment to immediately preoperatively: 24 hours.
It will be assessed if the preparation for the intervention, the indication, the intervention itself, the subsequent care and the benefits, risks and alternatives are known and understood. It will be analyzed using a multi-choice questionnaire.
Change in Anxiety from baseline to immediately preoperatively using a Visual analogue scale (0-10) and State-Trait Anxiety Inventory (20-80).
Time frame: From baseline at preoperative assessment to immediately preoperatively: 24 hours.
It will be assessed if the preparation for the intervention, the indication, the intervention itself, the subsequent care and the benefits, risks and alternatives are known and understood. It will be analyzed using a multi-choice questionnaire.
Change in satisfaction from baseline to immediately preoperatively using a Visual analogue scale (0-10).
Time frame: From baseline at preoperative assessment to immediately preoperatively: 24 hours.
It will be assessed if the preparation for the intervention, the indication, the intervention itself, the subsequent care and the benefits, risks and alternatives are known and understood. It will be analyzed using a multi-choice questionnaire.
2 secondary outcomes
Assessment the association between all of variables through a descriptive analysis using SPSS.
Time frame: Through study completion: 18 months
To contrast differences in the variables of both arms through a descriptive analysis using SPSS.
Time frame: Through study completion: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Derived from this study: PubMed 40526354Garcia Jurado PB, Espejo Herrero JJ, Lombardo Galera MS, Perez Montilla ME, Barranco Acosta S, Garcia-Revillo Garcia J, Font Ugalde P, Alvarez Benito M. Impact of the clinical role of interventional radiologists: results of the CLINTERVENTIONAL randomized controlled trial. Eur Radiol. 2025 Dec;35(12):7658-7668. doi: 10.1007/s00330-025-11757-0. Epub 2025 Jun 17.
- Derived from this study: PubMed 39812733Garcia Jurado PB, Espejo Herrero JJ, Lombardo Galera MS, Perez Montilla ME, Barranco Acosta S, Garcia-Revillo J, Font Ugalde P, Alvarez Benito M. CLINTERVENTIONAL protocol: a randomized controlled trial to evaluate clinical consultations and audiovisual tools for interventional radiology. Eur Radiol Exp. 2025 Jan 15;9(1):6. doi: 10.1186/s41747-024-00545-y.
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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.
Pedro Blas García Jurado, MD principal investigator
Reina Sofia University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-procedural consultation and audiovisual tools in people with Interventional Radiology and Physician-Patient Relations, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
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 7 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 5 Jan 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 Spain. 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 Pedro Blas Garcia Jurado, MD (0034957010872, pedroblasgj@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knowledge from baseline to immediately preoperatively using a multi-choice questionnaire. Where the patient's knowledge was assessed related to the intervention. (time frame: From baseline at preoperative assessment to immediately preoperatively: 24 hours.). The study lists 3 primary outcomes in all. 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 NCT05461482, which also lists 2 linked publications.
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 5 Jan 2024.