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临床试验/NCT02967601
NCT02967601已完成不适用

Influence of Preoperative Anxiety on Shivering During Elective Caesarean Section Under Spinal Anaesthesia

Bartłomiej Wódarski1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
Correlation between shivering and anxiety (STAI score)

研究概览

简要总结

Background Shivering occurs in circa 50 percent of cases during caesarean section under spinal anesthesia. The phenomenon's reasons and its mechanism are unclear, and while it does not endanger the patients' health, the sensations proved to be unpleasant and a subject of a number of patients' complains.

Objectives The main objective of the study is to establish the anxiety factors that influence the risk of muscle-shivering and a detailed assessment of the probability of existence of the link between increased anxiety levels with the shivering in case of patients undergoing the elective caesarean section.

Moreover, the outcomes of the study could help to further understand the phenomenon, reduce its occurence and as a result of that - improve the comfort of the patients in the perioperative period, as well as reduce the frequency of pharmacological treatment to halt the symptoms of muscle shivering.

Methodology Patients would be asked to fill the STAI (State - Trait Anxiety Inventory) questionaire in the morning preceding the surgery. Results would be interpreted by one of the investigators, who obtained a masters degree in psychology. Caesarean section under spinal anesthesia would be performed according to standard procedures used in the Samodzielny Publiczny Szpital Kliniczny Centrum Medyczne Kształcenia Podyplomowego (SPSK CMKP) hospital, with standard non-invasive monitoring (HR, noninvasive blood pressure (NIBP), oxygen saturation (SpO2), Temperature). Additionally, the anesthesiologist would note the incidence of shivering and its precise timing 1. since the spinal block 2. since the child-birth. Moreover, patients would rate anesthesiology team influence on her anxiety level during the cesarean section in 5 grade scale - data would be collected by psychologist.

The survey is planned for a one year timespan or until 200 patients have enrolled.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • age > 18 y.o.
  • signed informed consent form after reading the information about the study and talking with one of the investigators

排除标准

  • conversion to general anesthesia
  • any severe obstetric complications, which affects obstetric or anesthesiology procedure
  • severe bleeding
  • language barrier
  • anxiolytic/psychotropic drugs use

结局指标

主要结局

Correlation between shivering and anxiety (STAI score)

时间窗: during elective cesarean section

次要结局

  • Correlation between shivering and patient's temperature (noninvasive)(during elective cesarean section)
  • Correlation between shivering and patient's subjective assesment of anesthesiology team attitude(during elective cesarean section)
  • Correlation between shivering and patient's obstetric history socio-economical data.(during elective cesarean section)

研究者

发起方
Bartłomiej Wódarski
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Bartłomiej Wódarski

MD

Centre of Postgraduate Medical Education

研究点 (1)

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