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临床试验/NCT04540458
NCT04540458已完成不适用

Effect of 3D Ultrasounds and 3D Printed Models on Maternal and Paternal Fetal Attachment and Anxiety and Depression

Creighton University2 个研究点 分布在 1 个国家目标入组 288 人开始时间: 2020年2月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
288
试验地点
2
主要终点
Maternal Antenatal Attachment Scale (MAAS)

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

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

结局指标

主要结局

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

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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