The Effects of the Preoperative Operating Room Environment Presentation on Preanesthetic Anxiety and Blood Pressure in Hypertensive Patients: A Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- anxiety
研究概览
简要总结
The aim of this study was to investigate the effects of preoperative operating room environment introduction on preoperative hypertension and blood pressure in hypertensive patients.
详细描述
Procedure to be Applied:
In order to eliminate the other factors that cause essential HT, the patients' blood pressure due to HT should be controlled, the surgery will be planned as the first case in the morning and the patients will need 8 hours fasting period.
Patients' gender, age, height, weight values, ASA scores, body mass index (BMI) values will be recorded. Hemodynamic parameters (blood pressure, heart rate and SpO2 values) will be recorded in the services of the patients, in the preop unit and in the operation room. Hypertension requiring intervention or additional medication will be excluded from the study. A randomized number of patients will be included in the study according to the results of power analysis.
Introduction of the operating room environment (IORE): The procedure to be performed on the day of surgery will be simulated and accompanied by an anesthesiologist. The patient's hemodynamic data (blood pressure, pulse rate, respiratory rate, SpO2) will be measured at the time of operation, between 16: 00-18: 00 hours prior to the operation, and will be brought to the operating room with a service nurse. The hemodynamic data of the patient will be measured in the preop unit and the patient will be taken to the operating room with anesthesia doctor. Here, in addition to the patient's hemodynamic data, the instantaneous state anxiety scale (ST-STAI) will be completed and the patient will be left in service again. The procedure will be similar to the process that the patient will experience on the operation day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective surgery
- •informed consent,
- •essential hypertension was diagnosed,
- •Between the ages of 40-80,
- •American Society of Anesthesiologists (ASA) class II-III
排除标准
- •drug allergy,
- •with a history of malignant hyperthermia,
- •uncontrolled hypertension,
- •cancer and psychological problems,
- •patients with cardiac and endocrine diseases
- •emergency surgery
研究组 & 干预措施
Group IORE
This group will undergo the IORE procedure before surgery (operation). On the day of surgery, the patient will be brought to the operating room by the anesthesiologist. Hemodynamic data (blood pressure, pulse rate, respiratory rate, SpO2) will be measured at the service, preop unit and operating room. The anxiety level in the operating room will be measured by the ST-STAI scale.
干预措施: Group IORE (Behavioral)
Group NoIORE
The patient's hemodynamic data will be measured in the evening service before surgery. The patient will be brought to the operating room by the anesthesiologist on the day of surgery and hemodynamic data (blood pressure, pulse rate, respiratory rate, SpO2) will be measured in the preop unit. The hemodynamic data and the ST-STAI scale will measure the anxiety level in the operating room.
结局指标
主要结局
anxiety
时间窗: 1 day
The patient's anxiety will be measured by instantaneous state anxiety scale (ST-STAI)
次要结局
未报告次要终点
研究者
Nureddin YUZKAT
Assist. prof.
Yuzuncu Yıl University