Patient Satisfaction Clinical Trial
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.
Status | Recruiting |
Enrollment | 428 |
Est. completion date | April 2024 |
Est. primary completion date | April 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | To be eligible, each patient must meet one of the inclusion criteria and none of the exclusion criteria. Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario Reina Sofia | Córdoba |
Lead Sponsor | Collaborator |
---|---|
Maimónides Biomedical Research Institute of Córdoba |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | From baseline at preoperative assessment to immediately preoperatively: 24 hours. | |
Primary | 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. | From baseline at preoperative assessment to immediately preoperatively: 24 hours. | |
Primary | 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. | From baseline at preoperative assessment to immediately preoperatively: 24 hours. | |
Secondary | 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 | Through study completion: 18 months | |
Secondary | 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. | Through study completion: 18 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT04079543 -
NPO and Patient Satisfaction in the Cath Lab
|
N/A | |
Enrolling by invitation |
NCT05053958 -
Using Superimposition of Intra-Oral Scan and CBCT in Single Implant Restorations in Aesthetic Zone.
|
N/A | |
Completed |
NCT04204785 -
Noise in the OR at Induction: Patient and Anesthesiologists Perceptions
|
N/A | |
Completed |
NCT04774562 -
The Effect of Video-Assisted Discharge Education After Total Hip Replacement Surgery
|
N/A | |
Terminated |
NCT04604340 -
Radial Versus Femoral Arterial Access for Cerebral Angiography in Adolescents
|
N/A | |
Recruiting |
NCT04539210 -
Screw-retained Maxillary Complete Denture With Electric Welded Metal Framework Versus Cast One, Patient Satisfaction Assessment.
|
N/A | |
Completed |
NCT02924974 -
Spinal Morphine in Robotic Assisted Radical Prostatectomy
|
Phase 4 | |
Completed |
NCT01052415 -
POL and Access Intervention to Reduce HIV Stigma Among Service Providers in China
|
N/A | |
Recruiting |
NCT06044103 -
Patient-controlled Sedation During Repair of Obstetric Perineal Lacerations
|
Phase 4 | |
Not yet recruiting |
NCT05670080 -
Does MI Have a Therapeutic Role in Arthroscopic Rotator Cuff Repair?
|
N/A | |
Completed |
NCT06141122 -
The Colonoscopy Booklet:Effect of a Recipe Resource on Quality of Colonoscopy Bowel Preparation and Patient Experience
|
N/A | |
Completed |
NCT06114524 -
Effect of Binaural Beats on Level of Anxiety and Toleration in Patients Undergoing Upper Gastrointestinal Endoscopy Without Sedation
|
N/A | |
Not yet recruiting |
NCT04534868 -
Patient Acceptance And Satisfaction of Teledermoscopy In General Practice In a Belgian Rural Area
|
N/A | |
Completed |
NCT04823390 -
Anesthetist Controlled Versus Patient-controlled Sedation: Risks and Benefits
|
Phase 1 | |
Recruiting |
NCT05884684 -
What is the Potential Impact of Reviewing Post-procedure Images With Patients Following Interventional Spine Procedures.
|
N/A | |
Recruiting |
NCT05613439 -
The Fast-track Centre for Hip and Knee Replacement Database
|
||
Recruiting |
NCT06451510 -
Knee Osteoarthritis in the Region of Norrbotten
|
||
Withdrawn |
NCT04625842 -
Focus Group Interview Study on Patient Experiences and Satisfaction
|
N/A | |
Completed |
NCT04420000 -
Effects of Mindfulness Therapy in Patients With Acromegaly and Cushing
|
N/A | |
Recruiting |
NCT04842240 -
Comparison of Patient Reported Outcome Measures Using the BREAST-Q Questionnaire in Patients Undergoing Pre Versus Sub-pectoral Implant Based Immediate Breast Reconstruction.
|