Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
FEMALE
Healthy Volunteers
NCT07364032

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

Led by Universite Cote d'Azur · Updated on 2026-01-23

70

Participants Needed

1

Research Sites

187 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 45Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant women between 12 and 28 weeks of gestation (3 to 7.5 months)
  • Ability to speak and read French to understand study documents and complete questionnaires
  • Willingness to participate and accept random assignment to a study group
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Clara Beauvois Cabinet de psychologie

Mouans-Sartoux, France, 06370

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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