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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
300
new preoperative information method, based on multimedia tools and on the objective control of understanding by the patient candidate for vertebral or urological surgery.
Istituto Ortopedico Rizzoli
Bologna, Italy
RECRUITINGClient 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).
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