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

NCT07364032 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-01-23

No results posted yet for this study

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.

Conditions

  • Mindfulness Protocols
  • Pregnancy

Interventions

BEHAVIORAL

Mindfulness program

6 weeks of mindfulness

OTHER

Consultations

6 week of consultation with 1 consultation per week

Sponsors & Collaborators

  • Universite Cote d'Azur

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-31
Primary Completion
2026-08-30
Completion
2026-10-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07364032 on ClinicalTrials.gov