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临床试验/NCT02599610
NCT02599610Unknown不适用

Effects of Digital Vaginal Examination During Labor on Pain and Anxiety : a Randomised Controlled Trial

Ankara University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
Anxiety levels

研究概览

简要总结

Digital vaginal examination is the most common method for assessing progress of labor and delivery. Considering it is the most common intervention women receive during course of labor, evidence for psychological effects of digital vaginal examination on women is surprisingly sparse. Reducing the number of vaginal examination during labor has been proposed by many authors as benefit of more vaginal examination is unclear. However this is unlikely to happen until more research on the topic demonstrates clear detrimental effects of vaginal examination.

Our study is aimed at investigating association of vaginal examination with psychological distress of women during labor. Anxiety during labor is associated with longer labor duration, increased perception of pain, problems with newborn attachment, and increased rates of postpartum depression and post-traumatic stress disorder. In this study, women were assigned to either digital vaginal examination or transperineal ultrasound assessment groups were compared to each other in a randomised controlled setting.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Outcomes Assessor)

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

  • Multiparous women
  • Spontaneous active labor
  • Cephalic presentation

排除标准

  • Women with known psychiatric disorders
  • Labor induction
  • Advanced labor during admission (Dilatation greater than 7cm)
  • Presence of a prenatally diagnosed anomaly in fetus
  • Admission to neonatal intensive care unit after delivery
  • Delayed hospital discharge due to excessive weight loss of neonate

结局指标

主要结局

Anxiety levels

时间窗: Between 12 to 48 hours

Anxiety levels of the patients will be assessed with the State-Trait Anxiety Inventory (STAI) questionnaire during admission, at the beginning of active phase of stage one and four hours after delivery.

Labor pain

时间窗: Between 12 to 48 hours

Perceived pain level of the patients will be assessed with Visual Analog Scale (VAS) questionnaire during admission, at the beginning of active phase of stage one and four hours after delivery.

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

Erkan Kalafat

Research Assistant

Ankara University

研究点 (2)

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