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| Name | Class |
|---|---|
| Cantonal Hospital of St. Gallen | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Video Group | Experimental | Video group receives standard informed consent plus an individualized procedure-specific educational video |
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| Control Group | Active Comparator | Control group receives standard informed consent, consisting of an in-person verbal consultation with the responsible neurosurgeon supplemented by written documentation and cranial models when applicable |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Informed Consent Video | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | 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. | Measurement at two timepoints: - preoperative: within 24 hours after consenting - postoperative: within 72 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Measurement at two timepoints: - preoperative: within 24 hours after consenting - postoperative: within 72 hours after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurosurgery, HOCH Health Ostschweiz, Kantonsspital St. Gallen, St.Gallen, Switzerland | Sankt Gallen | Canton of St. Gallen | 9007 | Switzerland |
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| ID | Term |
|---|---|
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| Standard informed consent | Procedure | Standard informed consent, consisting of an in-person verbal consultation with the responsible neurosurgeon supplemented by written documentation and cranial models when applicable |
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