NCT07364032 Comparison Between a Mindfulness-Based Program and Standard Therapeutic Follow-Up During Pregnancy
| NCT ID | NCT07364032 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universite Cote d'Azur |
| Condition | Mindfulness Protocols |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2023-03-31 |
| Primary Completion | 2026-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2023-03-31 with a primary completion date of 2026-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Frequently Asked Questions
Who can join the NCT07364032 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Mindfulness Protocols. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07364032 currently recruiting?
Yes, NCT07364032 is actively recruiting participants. Visit ClinicalTrials.gov or contact Universite Cote d'Azur to inquire about joining.
Where is the NCT07364032 trial being conducted?
This trial is being conducted at Mouans-Sartoux, France.
Who is sponsoring the NCT07364032 clinical trial?
NCT07364032 is sponsored by Universite Cote d'Azur. The trial plans to enroll 70 participants.