An interventional study of active informed consent in Spine Disease and Urologic Diseases, sponsored by Istituto Ortopedico Rizzoli. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Istituto Ortopedico Rizzoli · Not applicable, Interventional, and Health services research
This is an interventional, non-pharmacological, randomized controlled superiority study (RCT), multicenter, open label, parallel group.
The aim is to evaluate the effectiveness of a new preoperative information method, based on multimedia tools and on the objective control of understanding by the patient candidate for spinal or urological surgery.
174 studies on the registry are indexed under Spinal Diseases; 39 are open to participants now.
This study's enrollment of 300 is above the median of 60 across 106 interventional studies indexed under Spinal Diseases.
Browse Spinal Diseases studies →Istituto Ortopedico Rizzoli is the lead sponsor of 304 studies on the registry; 103 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The experimental group will be prepared for the surgery through the new information tools, a video will be administered with information about the various surgical possibilities, graphics and animations in order to direct the patient toward a more informed choice. Next, an interview with the surgeon will be arranged for the patient and care givers to be listened to and guided through the use of 3D-printed models into the best decision for the individual case (Shared Decision Making - SDM). Having decided on the surgery, patients with similar surgical programs will be guided in educational programs to reinforce information, understanding and long-term retention of the concepts learned. The course will conclude with a second interview with the surgeon and the signing of the standard informed consent.
Other: active informed consent
The control group of patients will be informed about the surgery according to standard practices. As per standard practice, the patient will meet with the physician before surgery for an explanatory interview and subsequent signing of informed consent.
new preoperative information method, based on multimedia tools and on the objective control of understanding by the patient candidate for vertebral or urological surgery.
Client Satisfaction Questionnaire
The primary outcome of the study will be measured: - by means of the Client Satisfaction Questionnaire, which provides a patient satisfaction score with a range from a minimum of 8 points (completely dissatisfied) to a maximum of 32 points (completely satisfied).
Time frame: baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3)
Comprehension Questionnaire
procedure-specific assessment tool designed ad-hoc to evaluate a patient's knowledge and understanding of the planned procedure and associated risks/alternatives.
Time frame: baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3)
Depression Anxiety Stress Scales (DASS-21)
is a 21-item self-report questionnaire designed to assess the severity of depression, anxiety, and stress symptoms over the past week
Time frame: baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3)
Numeric Rating Scale (NRS)
is a simple self-report measure in which patients rate their current pain intensity on an scale from 0 ("no pain") to 10 ("worst imaginable pain").
Time frame: baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3)
Oswestry Disability Index (ODI)
self-administered questionnaire that assesses the degree of disability and functional impairment across ten daily-activity domains.
Time frame: baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3)
International Prostate Symptom Score (IPSS)
Only for Urology patients: 7-item questionnaire that evaluates the severity of lower urinary tract symptoms and their impact on quality of life.
Time frame: baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3)
International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
Only for Urology patients: short, patient-completed questionnaire that measures the frequency, severity, and impact of urinary incontinence on quality of life.
Time frame: baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3)
International Index of Erectile Function (IIEF-5 )
Only for Urology patients: brief, 5-item self-report measure used to assess erectile function and screen for erectile dysfunction severity
Time frame: baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3)
Rate of Patients Declining Spine Surgery (Opt-Out Rate)
The proportion of patients in spine surgery population, who, after receiving full information, choose not to proceed with the planned surgery.
Time frame: baseline (T0)
Medico-Legal Outcomes
For each group, we will track through hospital records the number of medicolegal complaints or claims filed by patients, specifically those alleging inadequate informed consent or unexpected outcomes, related to their surgery within the follow-up period. The outcome will be reported as the count (or proportion of patients) with such complaints in each arm.
Time frame: baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3).
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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