Fetal 3D Avatar Creation for Pregnant Women

NCT04942197 | Unknown

• 1 other identifier: B-2106/688-302
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

• 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.

Conditions

Virtual Reality; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Changes after using the pregnant woman application

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

  1 month after examination

Study Arms (2)

Arm 1

EXPERIMENTAL

Participants who received three dimensional ultrasound with pregnancy application

Other: use pregnancy management application

Arm 2

PLACEBO COMPARATOR

Participants who received three dimensional ultrasound without pregnancy management application

Other: use pregnancy management application

Interventions

use pregnancy management application 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 1; Arm 2

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• If Pregnant women refuse to participate in this study

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeong-gi Do, 13620, South Korea

Location

Related Publications (1)

• 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.

  PMID: 36826976 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: June 28, 2021
• Study Start: June 2, 2021
• Primary Completion: November 30, 2021
• Study Completion: December 31, 2021
• Last Updated: June 28, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)