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临床试验/NCT05293795
NCT05293795招募中不适用

The Impact of 3D Ultrasound on Maternal-Fetal Attachment Among African American Women

Creighton University2 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2022年3月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
144
试验地点
2
主要终点
Maternal Stress

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 in African-American women.One-third of participants will receive 3D model and complete questionnaires, one-third will receive a picture of 3D ultrasound of their baby and complete questionnaires, and one-third will only complete the questionnaires

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
Female
接受健康志愿者

入选标准

  • Age - Female 19-45 years of age
  • Fluent in English
  • African American
  • Currently pregnant (between 26- and 31-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
  • Is not African American
  • Is not fluent in English

结局指标

主要结局

Maternal Stress

时间窗: 3 minutes

11-question Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ-R2) will be administered.

Maternal Depression

时间窗: 3 minutes

9-question Patient Health Questionnaire (PHQ-9) 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.)

Maternal Anxiety

时间窗: 3 minutes

7-question Generalized Anxiety Disorder questionnaire (GAD-7) 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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