Abstract
BACKGROUND: Health care is experiencing new opportunities in the emerging digital landscape. The metaverse, a shared virtual space, integrates technologies such as augmented reality, virtual reality, blockchain, and artificial intelligence. It allows users to interact with immersive digital worlds, connect with others, and explore unknowns. While the metaverse is gaining traction across various medical disciplines, its application in thyroid diseases remains unexplored. Subclinical hypothyroidism (SCH) is the most common thyroid disorder during pregnancy and is frequently associated with adverse pregnancy outcomes. OBJECTIVE: This study aims to evaluate the safety and effectiveness of a metaverse platform in managing SCH during pregnancy. METHODS: A randomized controlled trial was conducted at Fujian Provincial Hospital, China, from July 2022 to December 2023. A total of 60 pregnant women diagnosed with SCH were randomly assigned into two groups: the standard group (n=30) and the metaverse group (n=30). Both groups received levothyroxine sodium tablets. Additionally, participants in the metaverse group had access to the metaverse virtual medical consultations and metaverse-based medical games. The primary outcomes were adverse maternal and offspring outcomes, and the secondary outcomes included the neurobehavioral development of offspring and maternal psychological assessments. RESULTS: Of the 30 participants in each group, adverse maternal outcomes were observed in 43% (n=13) of the standard group and 37% (n=11) of the metaverse group (P=.60). The incidence of adverse offspring outcomes was 33% (n=10) in the standard group, compared to 7% (n=2) in the metaverse group (P=.01). The Gesell Development Scale did not show significant differences between the two groups. Notably, the metaverse group demonstrated significantly improved scores on the Self-Rating Depression Scale and the Self-Rating Anxiety Scale scores compared to the standard group (P<.001 and P=.001, respectively). CONCLUSIONS: The use of metaverse technology significantly reduced the incidence of adverse offspring outcomes and positively impacted maternal mental health. Maternal adverse outcomes and offspring neurobehavioral development were comparable between the two groups. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2300076803; https://www.chictr.org.cn/showproj.html?proj=205905.