NCT02541682已完成不适用
Assessment of the Relationship Between Affective Temperament and the Severity of Nausea and Vomiting in Early Pregnancy
Mustafa Kemalpasa Government Hospital1 个研究点 分布在 1 个国家目标入组 252 人开始时间: 2013年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- TEMPS-A scale measurement
研究概览
简要总结
In this study, the investigators aimed to research the relationship between affective temperament with the severity of the symptoms of nausea and vomiting in early pregnancy. The investigators aimed to assess temperament differences between healthy pregnant women and pregnant women suffering from mild, moderate, and severe hyperemesis gravidarum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 41 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •To be 16 years or older
- •To be at the level of education to understand and answer the survey questions
- •To have singleton live pregnancy within the first six weeks of pregnancy according to ultrasound measurement or the level of human chorionic gonadotropine in the blood
- •Agreed to participate the study by signing a voluntary informed consent form
排除标准
- •History of any medical problems (eg. endocrine, gastrointestinal, cardiovascular, pulmonary system diseases, vertigo)
- •Presence of a history of psychiatric disorder (eg. depression, anxiety, bipolar disorder, delirium, eating disorders and other psychotic disorders)
- •Multiple pregnancy
- •Pregnancy complicating situation (eg. imminent abortion, trophoblastic disease, ectopic pregnancy)
- •Presence of a history of regular medication use (Including drug use within the last six months for psychiatric illness)
- •To be not at the risk for anxiety disorder or depression according to the result of hospital anxiety and depression scale
结局指标
主要结局
TEMPS-A scale measurement
时间窗: 1 day
The participants filled out TEMPS-A survey at their first visit.
PUQE scoring index
时间窗: 2 months
The investigators performed this test to subjects three times of session separated by a month
次要结局
- Hospital anxiety and depression scale(1 day)
研究者
ALI BAHADIRLI
Specialist
Mustafa Kemalpasa Government Hospital
研究点 (1)
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