Randomized Trial of a Mindfulness Program Versus Standard Support During Pregnancy Effects on Maternal Well-being, Baby Outcomes, and Mother-Infant Bonding

What this Trial Is About

Researchers are evaluating the effects of a 6-week mindfulness meditation program compared to a standard psychological support program in pregnant women. The study aims to see if mindfulness can reduce negative feelings like stress, anxiety, depression, and sleep problems during pregnancy, while also improving positive feelings such as mindfulness skills, self-confidence, happiness, and life satisfaction. It also assesses effects on maternal-fetal attachment during pregnancy, mother-infant attachment postpartum, and infant outcomes. Participants in the mindfulness group will attend one guided meditation session each week led by an instructor and complete five additional audio meditation sessions at home weekly for six weeks. The comparison group will receive standard therapeutic follow-up with one consultation per week for six weeks. This randomized trial uses a triple masking method to compare these two approaches. During the study, participants will complete questionnaires at the start and after six weeks to assess anxiety, stress, depression, sleep disorders, mindfulness, self-efficacy, happiness, life satisfaction, and prenatal attachment. Infant crying and sleep disturbances will be evaluated through questionnaires up to one year after birth, and mother-infant interactions will be observed via video. The study runs until October 2026 and includes follow-up assessments to measure both maternal well-being and infant outcomes.

Comparison Between a Mindfulness-Based Program and Standard Therapeutic Follow-Up During Pregnancy