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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Standard Informed Consent

    Other intervention

    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 Supplemented Informed Consent

    Other intervention

    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.

Treatment groups

236 Participants
are divided into 2 treatment groups
Group A: Standard Informed Consent Group1 intervention
Group B: Visual support group1 intervention

Trial outcomes

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.

Time frame
30 minutes after completion of the informed consent information session

Secondary outcomes

1

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.

Time frame
30 minutes after completion of the informed consent information session

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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