跳至主要内容
临床试验/NCT06592807
NCT06592807已完成不适用

The Effect of Perioperative Warm Socks on Maintaining Body Temperature in Patients Undergoing Spinal Surgery: Randomized Controlled Trial

Kocaeli University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2023年7月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
1
主要终点
Tympanic temperature measurement

研究概览

简要总结

It is important to maintain the body temperature of patients during spine surgery because hypothermia that occurs during surgery can increase the risk of complications and negatively affect the recovery process. For this reason, various methods are being investigated to maintain the body temperature of patients during and after surgery. Warm socks application is a simple and effective method performed by putting warm socks on the feet of patients. This application has been shown to better maintain the body temperature of patients during the perioperative period and may reduce the incidence of hypothermia. Warm socks help maintain body temperature by increasing blood circulation and reducing heat loss. As a result, warm socking application is considered a useful and recommended method for maintaining body temperature in patients undergoing surgery.

详细描述

Hypothermia during surgery is a common problem among patients undergoing surgery. It is known that approximately half of the patients who undergo surgery develop hypothermia. Hypothermia is defined as a central temperature below 36°C. The body temperature of patients decreases during the first hour of general anesthesia and continues to decrease when the surgery exceeds 2 hours. In the event of hypothermia, the patient develops a physiological shivering response. It can also increase patients oxygen consumption by up to 40%. Active and passive heating methods are used to prevent this. Warm socks are one of the passive heating methods.

In the preoperative period, putting pre-warmed socks on patients is effective in maintaining core body temperature, controlling shivering response and ensuring thermal comfort of patients. Pre-warmed socks are a noninvasive, easy-to-wear, painless and cost-effective method to prevent body temperature loss. The application of warm socks is also a method that allows the patient position to be changed and surgical preparation, is comfortable for the patient, reduces preoperative anxiety and can be applied without a physician order.

Study Population and Sampling: The universe of the study will consist of patients who underwent spinal surgery in the Operating Room of Istanbul Bakırköy Prof. Dr. Mazhar Osman Mental Health and Nervous Diseases Education and Research Hospital on the specified dates.

Sample: In the study, Gpower was used to determine the effect of perioperative warm socks application on maintaining body temperature in patients undergoing spinal surgery. The study findings reported by Lee et al. were used to determine the d value, which is the effect size index. It was calculated as α= 0.05, power=0.80 d=0.63. The sample was determined as 32 people for each group, a total of 64 patients.

Randomization: The research was conducted as double blind randomized and controlled experimental study. A simple computer-assisted randomization method was used to distribute the groups homogeneously.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

The researchers who collected data and analyzed the study results were different.

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • The patient must be between 18-64 years old
  • Able to understand and speak Turkish
  • In the ASA1,2,3 class according to the ASA classification
  • Not have anemia, coagulation problems, peripheral circulation disorders or a metabolic disease
  • Willing to undergo spine surgery (LDH,SDH, scoliosis, stabilization)
  • Not undergoing spinal and local anesthesia
  • Volunteering to participate in the study

排除标准

  • The patient's surgery lasting less than 2 hours or more than 5 hours
  • The patient's socks are removed during the surgery
  • The patient's tympanic body temperature is not checked during the surgery
  • Complications develop during and after the surgery
  • The patient is taken to intensive care immediately after the surgery

结局指标

主要结局

Tympanic temperature measurement

时间窗: Every half hour during the surgery. (Until the 5th hour)

It is the measurement of the patient's temperature via the tympanic route.

Shivering

时间窗: It measured once at the 1st minute after surgery.

To determine the degree of the patient shiver, the researcher observed the patient. Then, patient gave a score between 0 and 4 to rate. 0: No signs of shiver. 4: Mean teeth chattering shiver.

次要结局

  • Subjectıve thermal comfort(It measured at the 15th minutes after surgery.)
  • Visual analog scale: Pain(It measured at the 15th minutes after surgery.)
  • Body temperature(Measured every 15 minutes for the first hour after surgery.)
  • Pulse(Measured every 15 minutes for the first hour after surgery.)
  • Spo2(Measured every 15 minutes for the first hour after surgery.)
  • Respiration(Measured every 15 minutes for the first hour after surgery)
  • Blood pressure(Measured every 15 minutes for the first hour after surgery.)

研究者

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

Hatice Merve Alptekin

Research Assistant

Kocaeli University

研究点 (1)

Loading locations...

相似试验