NCT07364032

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

A Randomized Controlled Trial Comparing a Mindfulness-based Program With Standard Therapeutic Follow-up During Pregnancy: Effects on Maternal Well-being, Infant Outcomes, and Mother-Infant Attachment

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Universite Cote d'Azur · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study aims to evaluate the effects of a 6-week mindfulness meditation program in pregnant women, compared with a psychological support control program. Participants in the mindfulness arm will complete one instructor-led meditation session per week and five guided audio meditation sessions at home each week. The primary objectives are to determine whether the mindfulness program leads to: Reduced negative affect, including stress, anxiety, depression, and sleep disturbances during pregnancy. Increased positive affect, such as mindfulness skills, self-efficacy, happiness, and life satisfaction. Enhanced maternal-fetal attachment during pregnancy and improved maternal-infant attachment one month postpartum. Improved mother-infant interaction quality at 3 months postpartum. More secure infant attachment at 12 months. Better infant outcomes, including reduced crying intensity/duration at 1 and 3 months, and improved sleep quality at 12 months. Overall, the study evaluates whether the mindfulness program provides greater benefits than a standard parenting support intervention.

Conditions

• Mindfulness Protocols
• Pregnancy

Interventions

Type	Name	Description
BEHAVIORAL	Mindfulness program	6 weeks of mindfulness
OTHER	Consultations	6 week of consultation with 1 consultation per week

Timeline

• Start date: 2023-03-31
• Primary completion: 2026-08-30
• Completion: 2026-10-31
• First posted: 2026-01-23
• Last updated: 2026-01-23

Locations

1 site across 1 country: France