Fetal 3D Avatar Creation for Pregnant Women

NCT ID: NCT04942197

Last Updated: 2021-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-02

Study Completion Date

2021-12-31

Brief Summary

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* 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.

Detailed Description

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* 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.

Conditions

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Virtual Reality Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Arm 1

Participants who received three dimensional ultrasound with pregnancy application

Group Type EXPERIMENTAL

use pregnancy management application

Intervention Type OTHER

Pregnant women who used pregnancy management application, which tells patients what she need to know during pregnancy, when to perform tests, and what precautions to take for your baby.

Arm 2

Participants who received three dimensional ultrasound without pregnancy management application

Group Type PLACEBO_COMPARATOR

use pregnancy management application

Intervention Type OTHER

Pregnant women who used pregnancy management application, which tells patients what she need to know during pregnancy, when to perform tests, and what precautions to take for your baby.

Interventions

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use pregnancy management application

Pregnant women who used pregnancy management application, which tells patients what she need to know during pregnancy, when to perform tests, and what precautions to take for your baby.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* If Pregnant women refuse to participate in this study
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeong-gi Do, South Korea

Site Status

Countries

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South Korea

References

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Lee KN, Kim HJ, Choe K, Cho A, Kim B, Seo J, Myung W, Park JY, Oh KJ. Effects of Fetal Images Produced in Virtual Reality on Maternal-Fetal Attachment: Randomized Controlled Trial. J Med Internet Res. 2023 Feb 24;25:e43634. doi: 10.2196/43634.

Reference Type DERIVED
PMID: 36826976 (View on PubMed)

Other Identifiers

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B-2106/688-302

Identifier Type: -

Identifier Source: org_study_id

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