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

NCT07461480 | Not Yet Recruiting

• 1 other identifier: 2026-02/32
• Study Type: observational
• Target: 236
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Anesthesia; Surgical Patients

Keywords

Informed Consent; Visual Support; Health Communication; Cluster Randomized Trial; Anesthesia Outpatient Clinic; Risk Awareness; Patient Education

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Anesthesia Awareness Score

  30 minutes after completion of the informed consent information session

Study Arms (2)

Standard Informed Consent Group

Other: Standard Informed Consent

Visual support group

Other: Visual Support Supplemented Informed Consent

Interventions

Standard Informed Consent OTHER

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.

Standard Informed Consent Group

Visual Support Supplemented Informed Consent OTHER

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.

Visual support group

Eligibility Criteria

• Age: 18 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asistant Doctor

Study Record Dates

• First Submitted: March 1, 2026
• First Posted: March 10, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03