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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anesthesia; Surgical Patients
• Intervention / Treatment: Other: Standard Informed Consent; Other: Visual Support Supplemented Informed Consent

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.

• Study Type: Observational
• Enrollment (Estimated): 236

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients presenting to the anesthesia outpatient clinic for routine preoperative evaluation prior to elective surgical procedures requiring anesthesia. Participants will be recruited consecutively during the preoperative assessment period.

The study includes patients who are able to read and understand Turkish and who are capable of providing informed consent. Patients undergoing emergency surgery, individuals with known cognitive impairment, and those unable to complete the questionnaire will be excluded.

This population represents typical preoperative anesthesia outpatients in a tertiary care hospital setting.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Standard Informed Consent Group	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.
Visual support group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Informed Consent Comprehension Score	The Anesthesia Preoperative Information and Informed Consent Comprehension Questionnaire is used to assess patients' understanding of the anesthesia informed consent process. The questionnaire includes 20 objective knowledge questions related to anesthesia procedures, risks, and patient rights. Each correct answer receives 1 point, while incorrect or "I do not know" responses receive 0 points. The total score ranges from 0 to 20, with higher scores indicating better understanding of the informed consent information.	30 minutes after completion of the informed consent information session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anesthesia Awareness Score	Anesthesia Knowledge Score Measured using the Anesthesia Preoperative Information and Informed Consent Comprehension Questionnaire knowledge section. The score ranges from 0 to 20, with higher scores indicating greater knowledge about anesthesia procedures and perioperative care.; Anesthesia Risk Awareness Score Assessed using questionnaire items related to awareness of common and rare anesthesia-related risks. Scores range from 0 to 10, with higher scores indicating greater awareness of anesthesia-related risks.; Perceived Adequacy of Information Score Measured using Likert-scale items evaluating patient perception of the adequacy and clarity of the information provided. The total score ranges from 10 to 50, with higher scores indicating greater perceived adequacy of the information provided during the consent process.	30 minutes after completion of the informed consent information session

Collaborators and Investigators

• Sponsor: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: March 1, 2026
• First Submitted That Met QC Criteria: March 6, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Informed Consent; Patient Education; Health Communication; Cluster Randomized Trial; Risk Awareness; Visual Support; Anesthesia Outpatient Clinic
• Other Study ID Numbers: 2026-02/32

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No