Assessment of the Relationship Between Affective Temperament and the Severity of Nausea and Vomiting in Early Pregnancy
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
研究组 & 干预措施
Control
Participants who have PUQE ( Pregnancy Unique Quantification of Emesis scoring index) score equal to 3 and showing no symptom of nausea and/or vomiting during the three control visits. Control visits are performed a month apart.
干预措施: TEMPS-A (Temperament Evaluation of Memphis, Pisa, Paris and San Diego Auto-questionnaire) (Other)
Mild nausea and vomiting of pregnancy
Participants who have maximum PUQE ( Pregnancy Unique Quantification of Emesis scoring index) score equal to 4-6 during the three control visits. Control visits are performed a month apart.
干预措施: TEMPS-A (Temperament Evaluation of Memphis, Pisa, Paris and San Diego Auto-questionnaire) (Other)
Moderate nausea and vomiting of pregnancy
Participants who have maximum PUQE ( Pregnancy Unique Quantification of Emesis scoring index) score equal to 7-12 during the three control visits. Control visits are performed a month apart.
干预措施: TEMPS-A (Temperament Evaluation of Memphis, Pisa, Paris and San Diego Auto-questionnaire) (Other)
Severe nausea and vomiting of pregnancy
Participants who have maximum PUQE ( Pregnancy Unique Quantification of Emesis scoring index) score equal to 13-15 during the three control visits. Control visits are performed a month apart.
干预措施: TEMPS-A (Temperament Evaluation of Memphis, Pisa, Paris and San Diego Auto-questionnaire) (Other)
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