NCT07364032

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress87%
Mar 2023Oct 2026

Study Start

First participant enrolled

March 31, 2023

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

3.4 years

First QC Date

December 9, 2025

Last Update Submit

January 16, 2026

Conditions

Mindfulness ProtocolsPregnancy

Outcome Measures

Primary Outcomes (9)

  • Anxiety

    French version of Pregnancy Related Anxiety Questionnaire (Reymond et al., 2020)

    Questionnaire will be completed at day 0 and 6 weeks later.

  • Stress

    French version of Short Stress scale (Cungi et al., 2003)

    Questionnaire will be completed at day 0 and 6 weeks later.

  • Depression

    French version of Edinburgh Postnatal Depression Scale, (Cox et al., 1987)

    Questionnaire will be completed at day 0 and 6 weeks later.

  • Sleep disorders

    French version of The Pittsburgh sleep quality index, (Buysse et al., 1989)

    Questionnaire will be completed at day 0 and 6 weeks later.

  • Mindfulness

    French version of Mindfulness Scale (Brown et Ryan., 2003)

    Questionnaire will be completed at day 0 and 6 weeks later.

  • Self efficacy

    French version of Generalized Self-Efficacy scale (Schwarzer et al., 1995)

    Questionnaire will be completed at day 0 and 6 weeks later.

  • Happiness

    French version of Subjective Happiness Scale (Lyubomirsky \& Lepper, 1997)

    Questionnaire will be completed at day 0 and 6 weeks later.

  • Satisfaction of life

    French version of The Satisfaction with Life Scale (Diener et al., 1985)

    Questionnaire will be completed at day 0 and 6 weeks later.

  • Prenatal Attachment

    French version of Prenatal Attachment Inventory, (Muller, 1993)

    Questionnaire will be completed at day 0 and 6 weeks later.

Secondary Outcomes (3)

  • Cries of the baby

    Questionnaires will be completed daily up to 1 and 3 months post partum

  • Sleep disturbances

    Questionnaires will be completed at 1 year Post partum

  • Post natal attachment

    video at 1 year

Study Arms (2)

Mindfulness program

EXPERIMENTAL
Behavioral: Mindfulness program

Classical

SHAM COMPARATOR
Other: Consultations

Interventions

Mindfulness programBEHAVIORAL

6 weeks of mindfulness

Mindfulness program
ConsultationsOTHER

6 week of consultation with 1 consultation per week

Classical

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clara Beauvois Cabinet de psychologie

Mouans-Sartoux, 06370, France

RECRUITING

MeSH Terms

Interventions

Referral and Consultation

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

December 9, 2025

First Posted

January 23, 2026

Study Start

March 31, 2023

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

October 31, 2026

Last Updated

January 23, 2026

Record last verified: 2026-01

Locations

FR(1)