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临床试验/NCT05481255
NCT05481255已完成不适用

Does the Menstrual Phase Affect Skin Puncture Pain During Spinal Anesthesia? Prospective, Observational Study

Konya Meram State Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年8月2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
80
试验地点
1
主要终点
spinal needle-puncture pain

研究概览

简要总结

This prospective observational study aimed to evaluate the relationship between menstrual phase cycles and spinal needle-puncture pain during spinal anesthesia in female patients of reproductive age.

详细描述

Before the spinal anesthesia procedure, the anxiety and depression levels of the patients will be evaluated with the 14-scale 'hospital anxiety and depression scale.' The spinal anesthesia procedure will be performed by the anesthesiologist responsible for the patient. At the end of the spinal anesthesia procedure, a researcher with no knowledge of the patient's menstrual phase information will ask rate the spinal needle-puncture pain felt during spinal anesthesia with a numerical rating scale (NRS), which is graded from 1 to 10 (0: no pain, 10: very severe pain).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female volunteers of reproductive age have had a regular menstrual cycle for at least six months

排除标准

  • Pregnancy
  • ASA physical status III and IV
  • Patients with psychiatric disorders,
  • Emergency surgeries
  • Mentally retarded patients,
  • Patients with multiple spinal anesthesia trials
  • Patients with previous spinal surgery experience

结局指标

主要结局

spinal needle-puncture pain

时间窗: 10 minutes

A numerical rating scale (NRS) will be used to assess spinal needle-puncture pain during spinal anesthesia, graded from 1 to 10 (0: no pain, 10: very severe pain).

次要结局

未报告次要终点

研究者

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

Betul Kozanhan

Ass.Prof.

Konya Meram State Hospital

研究点 (1)

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