The Effect of Maternal Exercise on Anxiety During Normal Pregnancy：a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 220
- 主要终点
- Change from Baseline of State Anxiety at 32 Weeks of Gestation
研究概览
简要总结
This is a randomized controlled trial study. We evaluate effectiveness of maternal exercise on anxiety during normal pregnancy compared to those who receive antenatal care regularly. We plan to recruit 220 healthy pregnant women over the age of 18 in Shenzhen and to use a standard maternal exercise from Korea as intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •Pregnant women who are over 18 years old and confirmed to be pregnant in Shenzhen Dapeng New District.
排除标准
- •1.pregnant women who have accepted maternal exercise training (at least twice a week in last month);2.pregnant women who have orthopedics, cardiovascular or mental diseases; 3.pregnant women who have or had any condition as follows:miscarriage more than two times,premature delivery,placenta previa,fetal dysplasia, low weight before pregnancy (BMI <17.5),polycyesis,preeclampsia,premature rupture of membranes,Uterine growth retardation,cervical/ligation,repeated vaginal bleeding,anemia or diabetes; 4.the gestational age is less than 12 weeks or more than 16 weeks;5.received psychotherapy or psychotropic medication within 6 months before the study;6.can not participate in regular inspections.
结局指标
主要结局
Change from Baseline of State Anxiety at 32 Weeks of Gestation
时间窗: The participants are examined between 12 and 16 weeks of gestation (baseline visit) and at gestation week 32 (after the intervention).
We use state anxiety subscale of State-Trait Anxiety Inventory (STAI) as the measure of anxiety severity. The STAI comprises two-self report scales for measuring two distinct anxiety concepts, the State anxiety and Trait anxiety. Both scales contain 20 statements that ask the respondent to describe how she feels at a particular moment (state anxiety) or how she generally feels (trait anxiety). State anxiety is conceptualized as a transitory emotional state, where as trait anxiety refers to relatively stable individual differences in proneness to anxiety. The respondents are required to rate themselves on a four point likert scale 'not at all' to 'very much so on' various anxiety related symptoms which they experience in the past weeks for the state scale or how they generally feel for the trait scale. STAI is widely used and has been shown to have high reliability and validity with a Cronbach's alpha of 0.88 and 0.83 for state (STAI-I) and trait anxiety (STAI-II) respectively.
次要结局
- Change from Baseline of Pain at 32 Weeks of Gestation(The participants are examined between 12 and 16 weeks of gestation (baseline visit) and at gestation week 32 (after the intervention).)
- Change from Baseline of Depressive Symptom at 32 Weeks of Gestation(The participants are examined between 12 and 16 weeks of gestation (baseline visit) and at gestation week 32 (after the intervention).)