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临床试验/NCT04942197
NCT04942197Unknown不适用

Evaluation of Fetal Realization Service Using Fetal 3D Avatar Creation and Health Care Application for Pregnant Women

Seoul National University Bundang Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年6月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Changes after using the pregnant woman application

研究概览

简要总结

  • Pregnant women can intuitively check the shape and development of the fetus through the 3D avatar that reflects the characteristics of the fetus. Through a survey on VR fetal experience content and 3D fetal avatar service, the satisfaction of pregnant women/guardians, the bond between the fetus and the mother, and Assess the degree of maternal anxiety.
  • Evaluate whether it can be helpful in prenatal monitoring of pregnant women through the use of maternity health management applications, and improve understanding of fetal growth and development.

详细描述

  • This study is an extension of the prospective pilot study conducted in 2020 under the title of "Development of 3D fetal avatar generation technology and fetal experience service technology reflecting the characteristics of pregnant women". In a previous study, about 80% of the mothers who responded to the questionnaire about the similarity of the avatar's fetal face gave a positive answer. Therefore, the developed 3D avatar fetal feeling technology is expected to have a positive effect on the intimacy between the mother and the fetus. want to analyze Pre-developed VR technology is provided through randomization to mothers who have agreed to participate in the study. In addition, objective comparison of prenatal care indicators is provided to mothers who wish to participate in this study by providing a prenatal management application that can comprehensively manage blood pressure, blood sugar, diet, exercise, maternal weight, medications, and expected fetal weight. We intend to evaluate the evaluation and maternal satisfaction.
  • If technology and services for simulating a fetus with a 3D fetal avatar are provided, mothers can obtain information such as the face and developmental status of the fetus specialized for their fetus through the 3D fetal avatar. In addition, providing a fetal heart rate simulation linked to the fetal heart sound improves the bond between the mother and the fetus, which can have a positive effect on health, as well as reducing depression during pregnancy and postpartum.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Participant)

入排标准

性别
Female
接受健康志愿者
是

入选标准

  • •Pregnant women receiving outpatient treatment at Seoul National University Bundang Hospital and pregnant women in the obstetrics and gynecology ward who wish to participate in this study

排除标准

  • •If Pregnant women refuse to participate in this study

研究组 & 干预措施

Arm 1

Experimental

Participants who received three dimensional ultrasound with pregnancy application

干预措施: use pregnancy management application (Other)

Arm 2

Placebo Comparator

Participants who received three dimensional ultrasound without pregnancy management application

干预措施: use pregnancy management application (Other)

结局指标

主要结局

Changes after using the pregnant woman application

时间窗: 1 month after examination

After 3D ultrasonography, at least 1 month later, a questionnaire about bonding between mother and fetus/maternal depression/health management is conducted.

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 (1)

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