RecruitingNot ApplicableNCT07364032

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


Sponsor

Universite Cote d'Azur

Enrollment

70 participants

Start Date

Mar 31, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria3

  • 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 Criteria3

  • 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.

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Interventions

BEHAVIORALMindfulness program

6 weeks of mindfulness

OTHERConsultations

6 week of consultation with 1 consultation per week


Locations(1)

Clara Beauvois Cabinet de psychologie

Mouans-Sartoux, France

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NCT07364032


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