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

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

Recruiting
18-45 years
Female
Phase N/A

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Overview

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.

Eligibility

Inclusion Criteria:

  • Pregnant women between 3 and 7.5 months of gestation (12-28 weeks).
  • Ability to speak and read French sufficient to understand study documents and complete questionnaires.
  • Willingness to participate in the study and to be randomized to one of the study groups.

Exclusion Criteria:

  • Loss of the baby
  • Participation in other prenatal support programs, including prenatal yoga, haptonomy, sophrology, or mindfulness courses.
  • Severe or unstable psychiatric disorder. Inability to understand French or complete study questionnaires.

Study details
    Mindfulness Protocols
    Pregnancy

NCT07364032

Universite Cote d'Azur

31 January 2026

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