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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 236
- 主要终点
- Informed Consent Comprehension Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Standard Informed Consent Group
干预措施: Standard Informed Consent (Other)
Visual support group
干预措施: Visual Support Supplemented Informed Consent (Other)
结局指标
主要结局
Informed Consent Comprehension Score
时间窗: 30 minutes after completion of the informed consent information session
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.
次要结局
- Anesthesia Awareness Score(30 minutes after completion of the informed consent information session)
研究者
SULTAN KONUK
Asistant Doctor
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital