Daily Meditation Program in Women Admitted to the Antepartum Unit: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Maternal state anxiety as assessed by the State Anxiety Scale
研究概览
简要总结
The purpose of this study is to assess whether a daily mindful meditation program for women admitted to the antepartum floor will decrease maternal state anxiety compared to routine care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age
- •≥ 23.0 weeks gestation
- •Planned inpatient care for > 3 days from randomization
- •Women cared for by UT physicians
排除标准
- •Known major lethal fetal anomalies (eg. trisomy 13, trisomy 18, anencephaly, Potter's Syndrome)
- •Non-English speaking women
- •Planned delivery ≤ 3 days from randomization
- •Previous fetal surgery in the current pregnancy (twin twin transfusion syndrome laser ablation, spina bifida repair, etc)
- •Women who have practiced a form of meditation in the current pregnancy (including yoga) in the last 4 weeks
- •Women who are currently using patient-controlled analgesia (PCA) (eg. sickle cell crisis)
- •Admission diagnosis of ecclampsia or HELLP (hemolysis, elevated liver enzymes, low platelets) syndrome
- •Diagnosed personality disorder including borderline personality disorder, histrionic personality disorder, schizoid personality disorder, schizotypal personality disorder, schizophrenia
- •Diagnosed anxiety, depression, bipolar or other psychiatric illness on medications for these disorders
- •Non-reassuring fetal heart tracing on admission
- •Intrauterine fetal demise at randomization
- •Inability to gain access to phone application
研究组 & 干预措施
Meditation
Intervention Group:
Routine care plus twice daily mindful meditation
干预措施: Meditation (Behavioral)
Meditation
Intervention Group:
Routine care plus twice daily mindful meditation
干预措施: Routine Care (Behavioral)
Routine care
Control Group:
Routine care which includes ACOG educational pamphlets on day 1, 2 and 3 after randomization
干预措施: Routine Care (Behavioral)
结局指标
主要结局
Maternal state anxiety as assessed by the State Anxiety Scale
时间窗: 1-3 days
The State Anxiety Scale Ranges from 20 to 80, with higher scores indicating a higher anxiety level.
次要结局
- Latency period(At delivery.)
- Maternal state anxiety as assessed by the State Anxiety Scale(1 to 11 weeks.)
- Stress as assessed by the Perceived Stress Scale(3 days to 11 weeks.)
- Depression as assessed by the Edinburgh Depression Scale(3 days to 11 weeks.)
- Patient satisfaction(3 days to 11 weeks.)
- Duration of meditation sessions(11 weeks)
- Number of meditation sessions(11 weeks)
研究者
Morgen Doty
Principal Investigator
The University of Texas Health Science Center, Houston