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NCT Number: NCT07364032

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

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.

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Key information

Conditions

Mindfulness Protocols Pregnancy

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Clara Beauvois Cabinet de psychologie

Mouans-Sartoux, 06370, France

Location status: Recruiting

Location contact

Clara Beauvois, Psychologist

CONTACT

[email protected]

+33769634713

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness program

Behavioral

6 weeks of mindfulness

Consultations

Other

6 week of consultation with 1 consultation per week

Primary outcomes

  1. Anxiety

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

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

  2. Stress

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

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

  3. Depression

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

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

  4. Sleep disorders

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

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

  5. Mindfulness

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

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

  6. Self efficacy

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

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

  7. Happiness

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

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

  8. Satisfaction of life

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

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

  9. Prenatal Attachment

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

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

Secondary outcomes

  1. Cries of the baby

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

    French Version Colic infant questionnaire (Bellaiche et al., 2021)

  2. Sleep disturbances

    Time frame: Questionnaires will be completed at 1 year Post partum

    French Version Sleep disturbance scale for children, (Lecuelle et al., 2020)

  3. Post natal attachment

    Time frame: video at 1 year

    French version of Baby Interaction Scale (Beaupuy. 2021) Pediatric Infant Parent Exam (PIPE, Fiese et al., 2001)

Sponsors and collaborators

Lead sponsor

Universite Cote d'Azur

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2026
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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