Comparison Between a Mindfulness-Based Program and Standard Therapeutic Follow-Up During P
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 p
| Condition(s) | Mindfulness Protocols, Pregnancy |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 i |
| Who can participate | 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. |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Universite Cote d'Azur |
| Locations | Mouans-Sartoux, France |
| Start date | 2023-03-31 |
| NCT ID | NCT07364032 |
| Official listing | https://clinicaltrials.gov/study/NCT07364032 |