Educational Informed Consent Video in Neurosurgery

Felix C. Stengel, MD

Status: Completed

Conditions: Informed Consent in Neurosurgery

Treatments: Procedure: Educational Informed Consent Video; Procedure: Standard informed consent

Study type: Interventional

Funder types: Other

Identifiers

NCT07064252

2022-0000687

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 171 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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171 participants in 2 patient groups

Video Group

Experimental group

Description:

Video group receives standard informed consent plus an individualized procedure-specific educational video

Treatment:

Procedure: Standard informed consent

Procedure: Educational Informed Consent Video

Control Group

Active Comparator group

Description:

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

Treatment:

Procedure: Standard informed consent