跳至主要内容
临床试验/NCT07348497
NCT07348497进行中(未招募)不适用

The Effect of Preoperative Education on Preoperative Anxiety and Emergence Agitation: A Randomized Controlled Trial

Yeditepe University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年12月12日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
80
试验地点
1
主要终点
Incidence of Emergence Agitation

研究概览

简要总结

This randomized controlled trial aims to evaluate the effect of structured preoperative education focused on the anesthesia emergence process on preoperative anxiety and postoperative emergence agitation in adult surgical patients undergoing general anesthesia. Emergence agitation is a frequent postoperative complication associated with patient discomfort, safety risks, and increased clinical workload. Preoperative anxiety is considered a modifiable risk factor for emergence agitation; however, evidence-based educational interventions targeting the emergence phase are limited.

The intervention consists of a standardized, nurse-led preoperative education program providing information on general anesthesia, endotracheal intubation and extubation, the post-anesthesia care unit environment, and expected physical and emotional responses during emergence. Education is delivered through a face-to-face individual session supported by written materials. Patients in the control group receive routine perioperative verbal information in accordance with standard care.

Eligible adult patients scheduled for elective general surgery under general anesthesia will be randomly assigned to either the intervention or control group. Preoperative anxiety will be assessed using the Amsterdam Preoperative Anxiety and Information Scale (APAIS). Emergence agitation will be evaluated in the post-anesthesia care unit using the Riker Sedation-Agitation Scale (SAS) and the Richmond Agitation-Sedation Scale (RASS) during the first 30 minutes after surgery.

The primary outcomes are preoperative anxiety levels and the incidence of postoperative emergence agitation. Secondary outcomes include postoperative pain, extubation time and quality, and length of stay in the post-anesthesia care unit. This study seeks to determine whether emergence-focused preoperative education can improve perioperative psychological outcomes and enhance patient safety in surgical care.

详细描述

This randomized controlled trial is designed to systematically evaluate the effect of structured preoperative education focused on the anesthesia emergence process on preoperative anxiety and postoperative emergence agitation in adult surgical patients undergoing general anesthesia. Emergence agitation is a common and clinically significant phenomenon in the immediate postoperative period and is associated with patient distress, safety risks, increased workload for healthcare professionals, and potential complications. Preoperative anxiety has been identified as a key modifiable risk factor contributing to emergence agitation; however, evidence-based educational interventions specifically targeting the emergence phase remain limited. The intervention consists of a standardized, nurse-led preoperative education program that provides patients with detailed information about the anesthesia emergence process. Educational content includes explanations of general anesthesia, endotracheal intubation and extubation procedures, the physical environment of the post-anesthesia care unit (PACU), expected physiological, emotional, and behavioral responses during emergence, and the typical duration and monitoring of the recovery process. Education is delivered in a face-to-face individual session lasting approximately 10-15 minutes and is supported by a written patient education brochure to ensure consistency and comprehension. Participants will be adult patients (≥18 years) scheduled for elective general surgery under general anesthesia at a tertiary training and research hospital. Eligible patients who provide informed consent and meet inclusion criteria will be randomly assigned to either the intervention group or the control group. Randomization will be performed using a computer-generated random sequence. The control group will receive routine perioperative verbal information in accordance with standard clinical practice, while the intervention group will receive routine care plus the structured emergence-focused education. Preoperative anxiety will be assessed on the day of surgery prior to anesthesia induction using the Amsterdam Preoperative Anxiety and Information Scale (APAIS). Postoperative emergence agitation will be evaluated in the PACU using the Riker Sedation-Agitation Scale (SAS) and the Richmond Agitation-Sedation Scale (RASS). Agitation assessments will be conducted at 10-minute intervals during the first 30 minutes following admission to the PACU, and the highest recorded score will be used for analysis. Emergence agitation will be defined as a SAS score ≥5 and/or a RASS score ≥+1. The primary outcomes of the study are the incidence and severity of emergence agitation and preoperative anxiety levels. Secondary outcomes include maximum postoperative pain scores in the PACU, time to extubation, extubation quality, and length of stay in the PACU. Demographic, clinical, and perioperative variables will be collected using a structured patient information form.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

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 general surgery under general anesthesia
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Able to comprehend the educational intervention
  • Willing and able to provide written informed consent

排除标准

  • History of neurological disorders, cognitive impairment, or dementia
  • Severe psychiatric illness or current use of antipsychotic medications
  • Alcohol or substance use disorder
  • Sensory impairments (visual, hearing, or speech) that may interfere with communication

研究组 & 干预措施

Experimental Group: Preoperative Emergence-Focused Education

Experimental

Participants in this group will receive routine perioperative care plus a structured, nurse-led preoperative education program focused on the anesthesia emergence process. The education includes information on general anesthesia, endotracheal intubation and extubation, the post-anesthesia care unit environment, and expected physical, emotional, and behavioral responses during emergence. Education is delivered individually in a face-to-face session lasting approximately 10-15 minutes and is supported by written educational materials.

干预措施: Preoperative Emergence-Focused Education (Behavioral)

Control Group: Standard Perioperative Care

Active Comparator

Participants in this group will receive routine preoperative and perioperative care in accordance with institutional clinical practice, including standard verbal information about the surgical and anesthesia process, without additional emergence-focused education.

干预措施: Standard Perioperative Care (Other)

结局指标

主要结局

Incidence of Emergence Agitation

时间窗: First 30 minutes after admission to the post-anesthesia care unit (PACU)

Patients' emergence agitation will be assessed using the Riker Sedation-Agitation Scale (SAS) and the Richmond Agitation-Sedation Scale (RASS). Patients with a maximum SAS score ≥5 and RASS score ≥ +1 will be considered positive agitation (the highest score within the first 30 minutes will be taken into account).

Preoperative Anxiety Level

时间窗: On the day of surgery, prior to induction of anesthesia

Patients' preoperative anxiety will be assessed using the Amsterdam Preoperative Anxiety and Information Scale (APAIS). Higher scores on the scale will be considered indicative of increased anxiety.

次要结局

  • Postoperative Pain Intensity(First 30 minutes after admission to the PACU)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

İnci Kırtıl

Assistant Professor

Yeditepe University

研究点 (1)

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