This single-center randomized controlled trial addresses a critical gap in neurosurgical practice by evaluating the effectiveness of video-assisted informed consent compared to standard consent procedures.
Importance: Informed consent in neurosurgery faces unique challenges due to procedural complexity and limited clinical time, with traditional methods often resulting in suboptimal patient comprehension. Objective: To determine whether preoperative educational videos improve patient comprehension and satisfaction compared to standard consent procedures in neurosurgical patients. Design: Single-center, non-blinded randomized controlled trial. Patients are randomized (1:1) using opaque envelope methods. Setting: Department of Neurosurgery, Kantonsspital St. Gallen, Switzerland. Intervention: Video group receives individualized educational videos plus standard consent. Control group receives standard consent only. Videos coveres surgical indication, anatomy, procedural details, and risks. Main Outcomes and Measures: Primary outcomes: patient comprehension via standardized questionnaires, satisfaction with consent process, psychological distress (Patient Health Questionnaire-4). Assessments conducted preoperatively and postoperatively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
171
Individualized procedure-specific educational video. Videos are developed by a multidisciplinary collaboration of neurosurgeons, medical educators, and patient advocates. Each video is tailored based on location of the pathology, surgical approach, positioning, anticoagulation intake, and intraoperative adjuncts such as electrophysiology. Each video followes a standardized format covering anatomical considerations, preoperative care, the surgical procedure, and postoperative care including potential complications, expected recovery process, and post-surgery instructions.
Standard informed consent, consisting of an in-person verbal consultation with the responsible neurosurgeon supplemented by written documentation and cranial models when applicable
Department of Neurosurgery, HOCH Health Ostschweiz, Kantonsspital St. Gallen, St.Gallen, Switzerland
Sankt Gallen, Canton of St. Gallen, Switzerland
Patient Comprehension
The investigators assess patients' comprehension through standardized questionnaires developed for neurosurgical procedures. Comprehension is evaluated by dichotomized responses: patients answering all questions correctly versus those who did not.
Time frame: Measurement at two timepoints: - preoperative: within 24 hours after consenting - postoperative: within 72 hours after surgery
Patient Satisfaction
The investigators assess patients' satisfaction through standardized questionnaires developed for neurosurgical procedures. To measure satisfaction with consent and information delivery we use a visual analogue scale (0-100, higher scores indicating greater satisfaction).
Time frame: Measurement at two timepoints: - preoperative: within 24 hours after consenting - postoperative: within 72 hours after surgery
Psychological Distress
The investigators evaluate psychological distress using the Patient Health Questionnaire 4 (PHQ-4). The PHQ-4 (Patient Health Questionnaire-4) is a brief, self-administered questionnaire used to screen for both anxiety and depression. It combines the PHQ-2 (a 2-item depression screener) and the GAD-2 (a 2-item anxiety screener). The PHQ-4 is designed to be a quick and easy way to identify individuals who may be experiencing symptoms of anxiety or depression, prompting further evaluation if needed. Scoring: Each item is scored on a 4-point Likert scale (0-3), and the scores are summed for each subscale (GAD-2 and PHQ-2) and the overall PHQ-4.
Time frame: Measurement at two timepoints: - preoperative: within 24 hours after consenting - postoperative: within 72 hours after surgery
Satisfaction with hospital stay
We measure satisfaction with the hospital stay and information delivery using a visual analogue scale (0-100, higher scores indicating greater satisfaction)
Time frame: Measurement at two timepoints: - preoperative: within 24 hours after consenting - postoperative: within 72 hours after surgery
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