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| ID | Type | Description | Link |
|---|---|---|---|
| ANR-15-IDEX-01 | Other Grant/Funding Number | Agence Nationale de la Recherche |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness program | Experimental |
| |
| Classical | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness program | Behavioral | 6 weeks of mindfulness |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cries of the baby | French Version Colic infant questionnaire (Bellaiche et al., 2021) | Questionnaires will be completed daily up to 1 and 3 months post partum |
| Sleep disturbances | French Version Sleep disturbance scale for children, (Lecuelle et al., 2020) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clara Beauvois Cabinet de psychologie | Recruiting | Mouans-Sartoux | 06370 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42419504 | Derived | Beauvois C, Soubelet A, Ranieri C. 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. Contemp Clin Trials. 2026 Jul 8:108401. doi: 10.1016/j.cct.2026.108401. Online ahead of print. |
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| ID | Term |
|---|---|
| D012017 | Referral and Consultation |
| ID | Term |
|---|---|
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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| Consultations |
| Other |
6 week of consultation with 1 consultation per week |
|
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. |
| Questionnaires will be completed at 1 year Post partum |
| Post natal attachment | French version of Baby Interaction Scale (Beaupuy. 2021) Pediatric Infant Parent Exam (PIPE, Fiese et al., 2001) | video at 1 year |