About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Age under 18 years
Emergency surgery cases
Known cognitive impairment or diagnosed psychiatric disorder affecting comprehension
Visual or hearing impairment preventing adequate communication Illiteracy
Trial 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.
Trial design
Other
Prospective
Treatments tested in this trial
Standard Informed Consent
Other interventionParticipants 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 Supplemented Informed Consent
Other interventionParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Anesthesia Awareness Score
1. 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. 2. 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. 3. 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.
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