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RECRUITING
NCT07364032
NA

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

Sponsor: Universite Cote d'Azur

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2023-03-31

Completion Date

2026-10-31

Last Updated

2026-01-23

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

Mindfulness program

6 weeks of mindfulness

OTHER

Consultations

6 week of consultation with 1 consultation per week

Locations (1)

Clara Beauvois Cabinet de psychologie

Mouans-Sartoux, France