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Completed

NCT Number: NCT07064252

Educational Informed Consent Video in Neurosurgery

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.

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Key information

Conditions

Informed Consent in Neurosurgery Behavior Health Behavior Patient Satisfaction Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurosurgery, HOCH Health Ostschweiz, Kantonsspital St. Gallen, St.Gallen, Switzerland

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The study population comprises adult patients scheduled for elective neurosurgical intracranial tumor resection

Exclusion criteria

  • Patients requiring emergency surgery
  • Patients with cognitive impairments preventing informed consent
  • Patients with significant language barriers impeding effective communication

Treatment and study plan

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.

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

Primary outcomes

  1. Patient Comprehension

    Time frame: Measurement at two timepoints: - preoperative: within 24 hours after consenting - postoperative: within 72 hours after surgery

    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.

  2. Patient Satisfaction

    Time frame: Measurement at two timepoints: - preoperative: within 24 hours after consenting - postoperative: within 72 hours after surgery

    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).

  3. Psychological Distress

    Time frame: Measurement at two timepoints: - preoperative: within 24 hours after consenting - postoperative: within 72 hours after surgery

    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.

Secondary outcomes

  1. Satisfaction with hospital stay

    Time frame: Measurement at two timepoints: - preoperative: within 24 hours after consenting - postoperative: within 72 hours after surgery

    We measure satisfaction with the hospital stay and information delivery using a visual analogue scale (0-100, higher scores indicating greater satisfaction)

Sponsors and collaborators

Lead sponsor

Felix C. Stengel, MD

Other

Collaborators

  • Cantonal Hospital of St. Gallen

Registry information

Official study title

Educational Informed Consent Video in Neurosurgery: A Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2025
First posted
Jul 14, 2025
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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