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临床试验/NCT04918368
NCT04918368已完成不适用

Do Low Vitramin D Levels Increase the Frequency of Sleep Disorders and Anxiety in the 2nd and 3rd Trimester?

Gaziosmanpasa Research and Education Hospital1 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2017年8月20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
225
试验地点
1
主要终点
Health Initiative Sleeplessness Scale (WHISS)

研究概览

简要总结

Lack of sleep and poor sleep quality in pregnant women are associated with maternal depression and cognitive-sensual irregularities. These irregularities were reported worsening women's life quality and even increasing suicide ideation. It is also associated with obstetrical complications such as fetal growth deficiency, preterm birth, prolonged labor, preeclampsia and increased abdominal delivery frequency.Vitamin D also may affect the sleep indirectly through the cases with nonspecific pains. It was reported that vitamin D levels are correlated with sleep disorders such as obstructive sleep apnea and restless legs syndrome. The primary purpose of this study is to examine sleep disorders and vitamin D levels in pregnant women, and also, secondarily, vitamin D - anxiety and sleep disorders - anxiety relations were assessed.

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 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • singletone pregnant women
  • second and third trimester pregnant women

排除标准

  • psychiatric disorder
  • sleep disorder

结局指标

主要结局

Health Initiative Sleeplessness Scale (WHISS)

时间窗: Through study completion, an average of 1 year

Women's Health Initiative Sleeplessness Scale (WHISS) was used to assess the sleep status of pregnant women. In this scale consisting of five questions, first four questions focus on the period of time when sleeplessness started, status of not being able to continue the sleep and waking up early in the morning, while the last one focusses to determine the sleep quality. Scores of the scale range between 0 - 20. A score equal and above 10 means a sleeplessness problem. An increase in score means intensifying the sleeplessness symptoms.

State Anxiety Scale (SAS)

时间窗: Through study completion, an average of 1 year

In anxiety screening of pregnant women, State Anxiety Scale (SAS) was used. Scores of the scale including twenty questions range between min. 20 and max. 80. Higher scores mean higher anxiety.

次要结局

未报告次要终点

研究者

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

Fatma ketenci gencer

Dr.

Gaziosmanpasa Research and Education Hospital

研究点 (1)

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