Educational Informed Consent Video in Neurosurgery

NCT07064252 | Completed

• 1 other identifier: 2022-0000687
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Informed Consent in Neurosurgery

Keywords

Informed consent; neurosurgery; Randomized controlled trial; video-assisted consent; Patient satisfaction; Patient comprehension

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (1)

• Satisfaction with hospital stay

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

Study Arms (2)

Video Group

EXPERIMENTAL

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

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

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

Procedure: Standard informed consent

Interventions

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.

Video Group

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

Control Group; Video Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Felix C. Stengel, MD: lead
• Cantonal Hospital of St. Gallen: collaborator

Study Sites (1)

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

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

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 14, 2025
• Study Start: March 1, 2022
• Primary Completion: August 31, 2023
• Study Completion: June 1, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)