Effect of 3D Ultrasounds and 3D Printed Models on Maternal and Paternal Fetal Attachment and Anxiety and Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- Paternal anxiety
研究概览
简要总结
To determine whether 3D models of fetus' face created from 3D ultrasound will increase maternal and paternal attachment, lower stress, anxiety and depression and have improved life-style choices during pregnancy. Half of participants will receive 3D model and half will receive a picture of 3D ultrasound of their baby.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age - Female 19-45 years of age; Male > 19 years of age
- •Currently pregnant (< 32 weeks gestation)
- •Have normal 20-week ultrasound
排除标准
- •Having received more than 3 ultrasounds prior to study
- •Medical need for additional ultrasounds
- •Multiple fetuses
- •> 31 weeks gestation
研究组 & 干预措施
Placebo
Mother or Mother/Father is given printed picture of 3D ultrasound of fetus
干预措施: Placebo (Other)
3D printed model
Mother or Mother/Father is given 3D printed model of fetus' face
干预措施: 3D printed model (Other)
结局指标
主要结局
Paternal anxiety
时间窗: 3 minutes
7-question Generalized Anxiety Disorder questionnaire (GAD-7) will be administered
Maternal stress
时间窗: 3 minutes
11-question Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ-R2) will be administered.
Maternal Antenatal Attachment Scale (MAAS)
时间窗: 5 minutes
The MAAS is a 19 item questionnaire measuring maternal-fetal attachment. Each item has five answer choices scored from 1 low attachment to 5 high attachment such that the total score ranges from 19 to 95. The measure also includes two subscales: (1) Quality of Attachment has 10 items with a range of 10-50 and measures the quality of the mother's attachment to her fetus. (2) Time measures the time spent in attachment mode (or intensity of preoccupation) and consists of 8 items for a range of 8 to 40. (for clarity one item included in the total score is not included in either subscale.)
Paternal Antenatal Attachment Scale (PAAS)
时间窗: 5 minutes
The PAAS is a 16 item questionnaire measuring paternal-fetal attachment. Each item has five answer choices scored from 1 low attachment to 5 high attachment such that the total score ranges from 19 to 95. The measure also includes two subscales: (1) Quality of Attachment has 10 items with a range of 10-50 and measures the quality of the mother's attachment to her fetus. (2) Time measures the time spent in attachment mode (or intensity of preoccupation) and consists of 8 items for a range of 8 to 40. (for clarity one item included in the total score is not included in either subscale.)
Maternal anxiety
时间窗: 3 minutes
7-question Generalized Anxiety Disorder questionnaire (GAD-7) will be administered
Paternal depression
时间窗: 3 minutes
9-question Patient Health Questionnaire (PHQ-9) will be administered
Maternal depression
时间窗: 3 minutes
9-question Patient Health Questionnaire (PHQ-9) will be administered
次要结局
未报告次要终点