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

Universite Cote d'Azur

Status

Enrolling

Conditions

Mindfulness Protocols

Pregnancy

Treatments

Behavioral: Mindfulness program

Other: Consultations

Study type

Interventional

Funder types

Other

Identifiers

NCT07364032

ANR-15-IDEX-01 (Other Grant/Funding Number)

CB-PCG-2022

Details and patient eligibility

About

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.

Enrollment

70 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.