Randomization and Protocol
nose, mouth, pregestational diabetes mellitus, gestational diabetes mellitus
FETAL FACE, GESTATIONAL DIABETES MELLITUS
During the study period, 88 eligible women were recruited and assigned randomly to either the VR intervention group or a standard-care group at a ratio of 1:1 by restricted randomization, which was generated with statistical software from the Medical Research Collaborating Center of the institution (Flowchart of participation in the study.As the baseline work-up, the participants in both groups received and filled out three questionnaires: (1) an MFA assessment, (2) a depressive-symptoms assessment, and (3) a basic health behavior status and medical information survey. After they finished the 3 questionnaires, all participants underwent 3D fetal ultrasonography and were shown the fetal images on an ultrasonography monitor; however, only the VR intervention group was shown fetal images that merged ultrasonographic data to produce VR images; these were viewed in a headset. The fetal images were generated in VR from the data obtained through ultrasonography of the subject’s own fetus and were shown only to the VR group. A prenatal-coaching mobile app was provided afterwards, and consistent education on how to use the various functions of the app was given to all participants. Approximately 2 weeks later, the researchers checked the interim feedback on the proper use of the prenatal-coaching mobile app, and a fourth questionnaire to assess maternal understanding of fetal appearance was given to all participants. All participants completed the trial in 4 weeks, lasting from enrollment to the end of trial. They then repeated the 3 questionnaires from the beginning of the study (All participants received the prenatal-coaching mobile app Aluvuu (available for both Android and iOS; Girjae Soft) when they were enrolled. This prenatal-coaching app provides services that enable submitting results for maternal weight and blood pressure and checking changes with intuitive graphs, and it includes a glucose-monitoring diary for participants with gestational diabetes mellitus or pregestational diabetes mellitus. Relevant information from authoritative guidelines on helpful activities (eg, yoga, exercise, and stretching) and a recommended diet were supplied according to gestational age (Screenshots of the prenatal-coaching mobile app: (A) glucose-concentration monitoring diary for mothers with gestational diabetes mellitus; (B) graph demonstrating maternal weight change; (C) diagram showing maternal blood pressure, glucose concentration, diet, and exercise at a glance; (D) information on helpful activities during pregnancy by gestational age (eg, yoga for late pregnancy).All participants viewed 3D ultrasonography images; however, the VR experience and the fetal images produced in VR were provided only to the VR intervention group (Fetal images produced in virtual reality: (A) fetal face and reconstructed image of the fetus generated in virtual reality based on 3D ultrasound–measured data of fetal body parts; (B) screenshots of the prenatal-coaching mobile app showing data converted from 3D ultrasounds and a graph demonstrating fetal growth (estimated based on data from ultrasound measurements).Additional services provided by the prenatal-coaching mobile app for the fetal images produced in virtual reality. (A) Progress in fetal growth at each gestational age in ultrasound images. (B) Interface for users to modify specific structures of the fetal face, such as the eyes, nose, mouth, and cheeks, in virtual reality.