ChiCTR2100043804已完成早期 1 期
减少心理应激和改善新生儿结果的线上围产期正念干预:随机对照试验
Self-financed1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2020年2月1日最近更新:
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Perceived stress
研究概览
简要总结
The present research is to develop and evaluate a prenatal mindfulness intervention for reducing psychological stress and improving neonatal outcomes among Chinese pregnant women.
The objectives of the study are:
- To evaluate the efficacy of the intervention in terms of the changes of primary outcome variable depression at T1, T2 & T3;
- To evaluate the efficacy of the proposed intervention in terms of the changes of process outcome variables including trait mindfulness and equanimity at T1, T2 & T3;
- To evaluate the efficacy of the intervention in terms of the changes of secondary outcome variables including anxiety, general and pregnant related stress, stress coping, satisfaction with life, and self-compassion at T1, T2 & T3;
- To examine the trajectory of depression and anxiety in relation to obstetric and neonatal outcomes after participants have given birth;
- To evaluate the effect of process outcome variables on mediating primarily outcome variables.
研究设计
- 研究类型
- 干预性研究
- 主要目的
- 随机平行对照
- 盲法
- None
入排标准
- 年龄范围
- 25 至 41（—）
- 性别
- Female
入选标准
- •Pregnancy at 2nd trimester (between 12th to 28th week gestation);
- •Chinese adults (age 18 or above) able to communicate in Chinese;
- •Being able to give informed consent;
- •Being willing and able to attend at least 7 sessions of the intervention/control program.
排除标准
- •Not able to understand Chinese (the intervention will be delivered in Chinese);
- •Undertaking any psychological treatments/meditation practices during pregnancy;
- •High-risk pregnancy status determined by obstetrician report (e.g., preterm labor, placental abnormality, multiple gestations, required bed rest, or morbid obesity);
- •Current psychiatric and mental disorders that necessitated priority attention (e.g., schizoaffective disorder, bipolar disorder, or current psychosis; organic mental disorder or pervasive developmental delay; current eating disorder; current substance abuse or dependence; Post-traumatic stress disorders; imminent suicide or homicide risk.
- •History of neurological problems such as epilepsy and seizures.
研究组 & 干预措施
Intervention group
Mindfulness-based intervention
Control group
Prenatal-psychoeducation
结局指标
主要结局
Perceived stress
Pregnancy distress
depression
anxiety
mindfulness
Equanimity
次要结局
- maternal attachment
- spirituality
- affect
- self-compassion
- Stress coping
- Social support
- Neonatal outcomes
- Obstetric outcomes
研究者
研究点 (1)
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