The Effect of Different Warming Methods Applied to Patients for Prevention of Hypothermia on Pain, Comfort and Some Parameters in Laparoscopic Cholecystectomy Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Body Temperature Scale
研究概览
简要总结
Cold gases given during laparoscopic cholecystectomy are the most important cause of hypothermia. However, even surgery alone is an 80% important cause of hypothermia. Inadvertent perioperative hypothermia is a common complication of the surgical process that can cause serious complications. In most of the patients, tremors, increase in pain, deterioration in comfort and changes in some physiological parameters can be seen. Despite this, there are not enough warming devices that nurses can use practically and are easy to use, affordable and comfortable for the patient. In the literature, it is stated in the evidence-based guidelines for determining the hypothermia risks of patients and taking early precautions.
详细描述
The parallel group randomized controlled three group study blinded by the evaluator aims to investigate the effectiveness of different warming methods in laparoscopic cholecystectomy patients. This study general surgery at Yozgat Bozok University Hospital in Turkey are performed in clinics. All patients are male and female patients who have undergone surgery and met the inclusion criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients are qualified to answer research questions,
- •BMI is between 18.5 kg / m2 and 30 kg / m2,
- •Not using therapeutic hypothermia in the surgery,
- •Not being treated with chronic opioids,
- •Operation time is between 60 minutes and 6 hours,
- •Having received general anesthesia during the operation,
- •Reception of patients with ASA classification I or II,
- •Absence of anemia, coagulation problem and peripheral circulatory disease or metabolic disease.
排除标准
- •Intraoperative and postoperative have complications (bleeding, arrest, nausea, vomiting, etc.),
- •Conversion of surgery from laparoscopy to open surgery.
结局指标
主要结局
Body Temperature Scale
时间窗: It is measured before surgery and every fifteen minutes after surgery (up to 2 hours). The change in Body Temperature Scale score before and within the first two hours after surgery is recorded.
It is the measurement chart prepared by the researcher. Includes measurement of body temperature over time.
Thermal Comfort Visual Analog Scale
时间窗: It is measured before surgery and every half hour after surgery (up to 2 hours). The change in thermal comfort score before and within the first two hours after surgery is recorded.
Horn et al. It is a visual assessment scale developed by. Thermal comfort is evaluated using a 100 mm long visual benchmark scale. Zero points represent the worst unbearable cold, 50 mm thermal comfort, 100 mm unbearable temperature. Objective responses of the patients were determined by making an evaluation from 0 to 100mm.
Pain Visual Analog Scale
时间窗: It is measured preoperatively and after the end of the operation at the 30th minute, 12th hour and 24th hour (up to 24 hours). Change from baseline Pain Visual Analog Scale scores at 24 hours.
The Visual Pain Scale is a scale of ten centimeters, created to inquire about the pain status of individuals. Zero indicates no pain while ten indicates the most severe pain. This chart is prepared as a blank line for self-evaluation and the prepared chart is read on the ruler.
次要结局
- Tremor Rating Scale(It is measured before and every 15 minutes after surgery (up to 1 hour). Changes in tremor from the first minute to an hour after surgery.)
- Hemoglobin Parameters Scale(The hemoglobin level is measured before surgery and at 24th hours after surgery (up to 24 hours). Change from baseline hemoglobin level scores at 24 hours.)
- International Normalized Ratio Parameters Scale(The Pt INR level is measured before surgery and at 1th hours after surgery (up to 1 hours). Change from preoperative Pt INR level at postoperative 1st hour.)
研究者
Aybike Bahçeli
Research Asistant
Bozok University