Informed consent is a fundamental ethical and legal component of anesthesia practice. However, previous literature has demonstrated that patients frequently have limited understanding of anesthesia procedures, associated risks, and their rights within the consent process. Written informed consent forms are often complex and may exceed recommended readability levels, potentially reducing comprehension.
This study is designed as a prospective, cluster-randomized controlled trial conducted in an anesthesia outpatient clinic. The objective is to evaluate whether supplementing standard written informed consent with structured visual support material improves patients' comprehension of the consent process and their level of anesthesia awareness.
Patients presenting to the anesthesia outpatient clinic for preoperative evaluation will be allocated in clusters of ten to one of two study arms:
Control Group: Standard written informed consent form.
Intervention Group: Standard written informed consent form supplemented with structured visual support material designed to present anesthesia-related information in simplified and visually supported format.
All patients will receive standardized verbal information delivered by the same anesthesiologist to minimize variability in explanation. The visual support material was developed based on current anesthesia guidelines and health communication principles.
To reduce assessment bias, outcome evaluation will be performed by a second anesthesiologist who is blinded to group allocation. Thirty minutes after completion of the information session, patients will complete a structured questionnaire assessing:
Comprehension of informed consent
Awareness of anesthesia procedures
Awareness of anesthesia-related risks and complications
The primary outcome measure is the difference between groups in informed consent comprehension scores. Secondary outcomes include differences in anesthesia awareness and risk recognition scores.
The study aims to provide evidence on whether visually supported communication strategies can enhance patient-centered informed consent processes in anesthesia practice.