The Effect of Anaesthesia Technique on Preoperative Fear of Death and Anxiety in Upper Extremity Surgery Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- APAIS (The Amsterdam Preoperative Anxiety and Information Scale)
研究概览
简要总结
This prospective, cross-sectional study aims to investigate the impact of planned anesthesia technique (general or regional anesthesia) and patients' previous anesthesia experience on preoperative anxiety in patients undergoing upper extremity surgery. The secondary objective is to identify the reasons for patients' anxiety related to anesthesia and surgery. Preoperative anxiety can lead to emotional, psychiatric, and physical problems, and is associated with increased autonomic fluctuations, anesthetic demand, postoperative nausea and vomiting, pain, prolonged recovery time, and hospitalization. The study will enroll 400 volunteers undergoing upper extremity surgery at Başakşehir Çam and Sakura City Hospital. Demographic information, surgical details, previous surgical and psychiatric history, substance abuse, and information about anesthesia will be collected. The Amsterdam Preoperative Anxiety and Information Form (APAIS) will be used to assess anxiety and desire for information, while the State-Trait Anxiety Inventory (STAI) will evaluate state and trait anxiety. Patients with an APAIS-A score ≥13 will be considered anxious, and those with an APAIS-B score ≥4 will be considered information-seeking. STAI scores will be interpreted based on percentile ranks and average score levels. The study aims to identify approaches to reduce preoperative anesthesia and surgery-related anxiety. SPSS Survey Analysis methods will be used for statistical analysis. The study duration is 12 months, from November 2024 to November 2025. Inclusion criteria are consenting patients aged 18-65 years, ASA I-III, undergoing upper extremity surgery under general or regional anesthesia, who are oriented and cooperative. Exclusion criteria include lack of consent, inappropriate age, ASA IV-V, non-upper extremity surgery, and inability to orient and cooperate.
详细描述
RESEARCH PROTOCOL
- The full name of the study:
The Effect of Anaesthesia Technique on Preoperative Fear of Death and Anxiety in Upper Extremity Surgery Patients 2. Purpose and importance of the research (primary purpose, secondary purposes, if any):
Preoperative anxiety is one of the most important problems for patients. Because it causes emotional and psychiatric problems as well as physical problems. To help patients, it is very important to identify the patient's current anxiety. Our primary aim in this study is to investigate how the planned anesthesia technique (general anesthesia or regional anesthesia) and the patients' previous anesthesia experience affect the patient's anxiety in patients undergoing upper extremity surgery (shoulder, arm, wrist, hand). Our secondary aim is to reveal the reasons for patients' anxiety about anesthesia and surgery. 3. Expected benefits and risks of the research:
Preoperative anxiety is very important as it has the potential to affect all aspects of anesthesia, including preoperative assessment, induction of anesthesia, perioperative and recovery periods. The exact etiology of anxiety may be related to anesthesia, surgery and many other causes. Perioperative anxiety is known to be associated with increased autonomic fluctuations and anesthetic demand, increased incidence of nausea and vomiting, and increased pain in the postoperative period. As a consequence of these complications, prolonged recovery time and hospitalization have been reported. In patients undergoing upper extremity surgery (shoulder, arm, wrist, hand), the anxious conditions caused by being close to the surgical site and team may vary according to the application of general anesthesia or regional anesthesia technique. With this study, we seek to answer the question 'what approaches should we develop to reduce the level of anxiety related to preoperative anesthesia and surgery in patients? Therefore, identifying and preventing patients' current anxiety to help patients are the benefits we expect. Since it will be a question and answer study with face-to-face interviews in the preoperative period in patients who will undergo upper extremity surgery, which is routinely performed in our hospital, there is no risk. 4. Type, scope and design of the planned study:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Consenting patients,
- •18-65 years old,
- •ASA-I-II-III
- •They will undergo upper extremity (shoulder, arm, wrist, hand) surgery,
- •They will receive General or Regional Anesthesia,
- •Oriented and cooperative patients,
排除标准
- •Patients without consent,
- •Not in the appropriate age range,
- •Patients with ASA-IV-V,
- •Those who will not undergo upper extremity surgery,
- •Patients who cannot orient and cooperate
结局指标
主要结局
APAIS (The Amsterdam Preoperative Anxiety and Information Scale)
时间窗: November 2024- June 2025
The Amsterdam Preoperative Anxiety and Information Scale The APAIS form includes 6 statements measuring anxiety and desire for information. Patients will be asked to give a value between 1-5 to 4 statements measuring anxiety (1, 2, 4 and 5.) and 2 statements measuring desire for information (3 and 6). The sum of the values given to the statements measuring anxiety constitutes the APAIS-A anxiety score, and the sum of the values given to the statements measuring the desire for information constitutes the APAIS-B desire for information score. Patients with an APAIS-A anxiety score of 13 and above will be considered 'anxious' and patients with an APAIS-B information seeking score of 4 and above will be considered 'seeking information'.
次要结局
- STAI-TX-1( State Anxiety Scale) and STA-TX-2 (Trait Anxiety Scale)(November 2024- June 2025)
研究者
Emine OZCAN
Principal Investigator
Başakşehir Çam & Sakura City Hospital