Effect of Visual Aids Added to Informed Consent on Patient Understanding and Anesthesia Awareness

Official title

The Effect of Visual Aids Used in Addition to the Informed Consent Form on Understanding of Consent and Level of Anesthesia Awareness in Patients Attending the Anesthesia Outpatient Clinic

Overview

This prospective cluster-randomized controlled study aims to evaluate whether visual support material provided in addition to the standard written informed consent form improves patients' comprehension of informed consent and their level of anesthesia awareness in an anesthesia outpatient clinic setting. Patients presenting to the anesthesia outpatient clinic will be allocated in clusters to receive either standard written informed consent alone or standard consent supplemented with structured visual support material. All patients will receive standardized verbal information delivered by the same anesthesiologist. Thirty minutes after the information session, comprehension of informed consent and anesthesia awareness levels will be assessed using a structured questionnaire administered in a standardized manner by a blinded anesthesiologist. The primary objective is to determine whether visual support enhances patient understanding of informed consent. Secondary objectives include evaluating its effect on anesthesia-related risk awareness and overall anesthesia knowledge.

Detailed description

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.

Interventions

• Other Standard Informed Consent
  Participants in this arm will receive the standard written informed consent form routinely used in the anesthesia outpatient clinic. In addition, standardized verbal information about anesthesia procedures, risks, and perioperative processes will be provided by the same anesthesiologist.
• Other Visual Support Supplemented Informed Consent
  Participants in this arm will receive the standard written informed consent form supplemented with structured visual support material designed to enhance comprehension of anesthesia procedures, risks, and patient rights. Standardized verbal information will also be provided by the same anesthesiologist.

Primary outcome measures

• Informed Consent Comprehension Score [Time frame: 30 minutes after completion of the informed consent information session]

Secondary outcome measures (1)

• Anesthesia Awareness Score [Time frame: 30 minutes after completion of the informed consent information session]

Eligibility criteria

Inclusion criteria

• Age ≥ 18 years
• Patients presenting to the anesthesia outpatient clinic for preoperative -evaluation
• Scheduled for elective surgery requiring anesthesia
• Able to read and understand Turkish
• Able to provide informed consent
• Willing to participate in the study

Exclusion criteria

• Age under 18 years
• Emergency surgery cases
• Known cognitive impairment or diagnosed psychiatric disorder affecting comprehension
• Visual or hearing impairment preventing adequate communication Illiteracy
• Previous participation in this study
• Refusal to participate

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07461480 · 2026-02/32

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗