Virtual RealityNCT04942197
Fetal 3D Avatar Creation for Pregnant Women
A study testing use pregnancy management application in people with Virtual Reality and Pregnancy, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality, Pregnancy
- What is being tested?
- use pregnancy management application
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Jun 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- If Pregnant women refuse to participate in this study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeong-gi Do, 13620
About this study
Official title: Evaluation of Fetal Realization Service Using Fetal 3D Avatar Creation and Health Care Application for Pregnant Women
- 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.
Read the detailed description
- 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
- Virtual Reality, Pregnancy
- Being tested
- use pregnancy management application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use pregnancy management applicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Participants who received three dimensional ultrasound with pregnancy application Receives: Other: use pregnancy management application |
| Arm 2 | Placebo comparator | Participants who received three dimensional ultrasound without pregnancy management application Receives: Other: use pregnancy management application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month after examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start2 Jun 2021
- Primary completion30 Nov 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942197
- Sponsor's protocol ID
- B-2106/688-302
- Status last verified
- Jun 2021
- First submitted
- 25 Jun 2021
- Last updated
- 28 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to disclose the records of mothers participating in the study.
Publications
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.
PubMed 36826976
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fetal Realization Service Using Fetal 3D Avatar Creation and Health Care Application for Pregnant Women
- ClinicalTrials.gov ID
- NCT04942197
- Acronym / sponsor ID
- B-2106/688-302
- Conditions
- Virtual Reality, Pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 28 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Other: use pregnancy management applicationParticipants who received three dimensional ultrasound with pregnancy application |
| Arm 2 | Placebo comparator | Other: use pregnancy management applicationParticipants who received three dimensional ultrasound without pregnancy management application |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- If Pregnant women refuse to participate in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| use pregnancy management applicationPregnant 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. | Other | Arm 1, Arm 2 |
Primary outcome
Changes after using the pregnant woman application
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
- Derived from this study: PubMed 36826976Lee 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.
- Individual participant dataSharing planned: No. There are no plans to disclose the records of mothers participating in the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing use pregnancy management application in people with Virtual Reality and Pregnancy, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes after using the pregnant woman application (time frame: 1 month after examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04942197, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2021.