Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-04-05 @ 2:14 AM
Study NCT ID:
NCT07364032
Status:
RECRUITING
Last Update Posted:
2026-01-23
First Post:
2025-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between a Mindfulness-Based Program and Standard Therapeutic Follow-Up During Pregnancy
Sponsor:
Universite Cote d'Azur
Organization:
Study Overview
Official 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
Status:
RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ANR-15-IDEX-01 | OTHER_GRANT | Agence Nationale de la Recherche | View |