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临床试验/NCT07647588
NCT07647588已完成不适用

The Effect of QR Code-Based Video-Supported Anesthesia Information on Preoperative Anxiety, Comprehensibility of Information, and Patient Satisfaction: A Prospective Randomized Controlled Study

Elazıg Fethi Sekin Sehir Hastanesi1 个研究点 分布在 1 个国家目标入组 284 人开始时间: 2026年6月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
284
试验地点
1
主要终点
Change in APAIS Anxiety Score

研究概览

简要总结

This study aims to evaluate the effects of QR code-based video-supported anesthesia information on preoperative anxiety, comprehensibility of information, and patient satisfaction in adult patients undergoing elective surgery.

Participants will be randomly assigned in a 1:1 ratio to either a control group receiving standard written informed consent and routine verbal anesthesia information or an intervention group receiving the same standard information plus a standardized video-based educational intervention accessed through a QR code.

The primary outcome is the change in the Amsterdam Preoperative Anxiety and Information Scale (APAIS) anxiety score before and after the information process. Secondary outcomes include comprehensibility of information and patient satisfaction assessed using a structured Likert-type questionnaire.

The findings may contribute to the standardization of patient information processes in anesthesia outpatient clinics through a low-cost and easily implementable digital educational approach.

详细描述

Informed consent and preoperative patient education are essential components of perioperative care. However, written consent forms may be difficult for some patients to understand because of technical language, limited consultation time, and variability in verbal explanations. Digital educational tools may provide standardized and more comprehensible information before surgery.

This single-center, prospective, parallel-group randomized controlled trial will evaluate whether QR code-based video-supported anesthesia information improves preoperative patient education compared with standard written informed consent and routine verbal anesthesia information. Adult patients scheduled for elective surgery will be randomized in a 1:1 ratio to either standard information alone or standard information plus access to a standardized educational video via QR code.

The video-supported intervention is designed to provide clear visual and auditory information about the anesthesia process, preparation before surgery, perioperative care, potential complications, common temporary side effects, patient rights, and the importance of informed consent. The study will assess whether this approach reduces preoperative anxiety and improves patients' understanding of anesthesia-related information and satisfaction with the information process.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

盲法说明

This is an open-label study. Participants and investigators are aware of group assignment because the intervention consists of a visible QR code-based video education program in addition to standard anesthesia information.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 years or older
  • Scheduled for elective surgery
  • Evaluated in the anesthesia outpatient clinic
  • Able to understand the study information and questionnaires
  • Able to provide written informed consent

排除标准

  • Emergency surgery
  • Impaired consciousness
  • Advanced dementia
  • Severe psychiatric illness
  • Severe visual, hearing, or cognitive impairment
  • Inability to understand the digital educational content
  • Refusal to participate
  • Inability to read or understand Turkish

研究组 & 干预措施

Control Group

No Intervention

Participants receive standard written informed consent and routine verbal anesthesia information according to routine clinical practice.

QR Video Group

Experimental

Participants receive standard written informed consent and routine verbal anesthesia information plus a standardized QR code-based video-supported anesthesia education program.

干预措施: QR Code-Based Video-Supported Anesthesia Information (Behavioral)

结局指标

主要结局

Change in APAIS Anxiety Score

时间窗: Immediately before and immediately after completion of the information process (same study visit)

Change in the Amsterdam Preoperative Anxiety and Information Scale (APAIS) anxiety subscale score from before the information process (T1) to after completion of the information process (T2). The APAIS anxiety subscale ranges from 4 to 20, with higher scores indicating greater preoperative anxiety.

次要结局

  • Information Comprehensibility Score(Immediately after completion of the information process)
  • Patient Satisfaction Score(Immediately after completion of the information process)

研究者

发起方
Elazıg Fethi Sekin Sehir Hastanesi
申办方类型
Other
责任方
Sponsor

研究点 (1)

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