About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged ≥ 18 years (with full legal capacity to consent).
Scheduled for elective surgery in one of the two domains: spinal surgery or radical prostatectomy in the waiting list of our centers.
Ability to comprehend Italian language.
Basic computer or internet access skills. Patients (or their family members) should have the ability to access multimedia content.
Disqualifiers
Patients under age: minors.
Inability to provide informed consent or self-determination (significant cognitive impairment, severe mental illness, or decisional incapacity that would prevent them from understanding the consent materials or participating in the decision-making).
Urgent or emergency surgery cases.
Trial design
Parallel
Treatments tested in this trial
active informed consent
Other interventionnew preoperative information method, based on multimedia tools and on the objective control of understanding by the patient candidate for vertebral or urological surgery.
Treatment groups
Trial outcomes
Primary outcomes
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).
Secondary outcomes
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.
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
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").
Oswestry Disability Index (ODI)
self-administered questionnaire that assesses the degree of disability and functional impairment across ten daily-activity domains.
Sponsors and contacts
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