RecruitingACTRN12626000091303

A randomized controlled trial comparing a mindfulness-based program with standard therapeutic follow-up during pregnancy

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

Sponsor

Beauvois Clara - Université Côte d'Azur

Enrollment

70 participants

Start Date

Mar 31, 2023

Study Type

Interventional

Conditions

Infant sleep difficulties Maternal mental health difficulties Depression Stress Mindfulness Anxiety Infant colic

Summary

To determine whether a 6-week mindfulness meditation program, compared with a psychological support program, leads to: Reduced negative affect (stress, anxiety, depression) and sleep disturbances in pregnant women; Increased positive affect (mindfulness, self-efficacy, happiness, life satisfaction); Improved maternal–fetal/infant attachment before birth and one month postpartum; Improved quality of mother–infant interaction patterns at 3 months postpartum; More secure infant attachment at 12 months; Better infant outcomes, including lower intensity and duration of crying (at 1 and 3 months) and improved sleep quality (at 12 months); Greater benefits compared with a standard parenting support program.

Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 45 Yearss

Plain Language Summary

Simplified for easier understanding

Pregnancy can be a time of great joy but also significant stress and emotional upheaval. Anxiety, depression, and sleep difficulties during pregnancy are common and can affect both the mother and the developing baby. This study is testing whether a six-week mindfulness meditation program helps pregnant women feel less stressed and more emotionally well, and whether those benefits extend to their babies and their relationship with their child after birth. Pregnant women will be randomly assigned to either the mindfulness program or a standard psychological support program. Researchers will measure mood, anxiety, sleep, sense of self-efficacy, and the quality of the mother-baby bond before birth and at several points up to 12 months after delivery. Infant outcomes like crying, sleep, and attachment security will also be tracked. You may be eligible if you are pregnant between 12 and 28 weeks, are able to read and understand French, and are not currently participating in other prenatal wellness programs such as prenatal yoga or sophrology. Women with severe or unstable psychiatric conditions are not eligible. This research may help provide better mental health support during one of life's most formative transitions.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

A 6-week mindfulness meditation program conducted 6 days per week, including one guided meditation session per week with a researcher (a licensed psychologist or a master's student in psychology under the supervision of a licensed psychologist) lasting one hour, and five additional guided sessions per week using 20-minute audio recordings. Each week, the meditation theme was: A precious grape seed, Body scan and body baby, The hot-air balloon, Meditation in unison, Loving–kindness connection meditation, Assessments and sessions take place either in a private practice setting or at the participant’s home. The mindfulness sessions will be delivered either face-to-face or via videoconferencing, depending on participant availability. The content, duration, and structure of the sessions will remain identical across both formats. Participants were excluded if they did not practice the meditation at least 5 times per week. All sessions are conducted individually.