Mindfulness Protocols, Pregnancy
Conditions
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.
Interventions
BEHAVIORALMindfulness program
6 weeks of mindfulness
OTHERConsultations
6 week of consultation with 1 consultation per week
Sponsors
Universite Cote d'Azur
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression | Questionnaire will be completed at day 0 and 6 weeks later. | French version of Edinburgh Postnatal Depression Scale, (Cox et al., 1987) |
| Mindfulness | Questionnaire will be completed at day 0 and 6 weeks later. | French version of Mindfulness Scale (Brown et Ryan., 2003) |
| Anxiety | Questionnaire will be completed at day 0 and 6 weeks later. | French version of Pregnancy Related Anxiety Questionnaire (Reymond et al., 2020) |
| Stress | Questionnaire will be completed at day 0 and 6 weeks later. | French version of Short Stress scale (Cungi et al., 2003) |
| Self efficacy | Questionnaire will be completed at day 0 and 6 weeks later. | French version of Generalized Self-Efficacy scale (Schwarzer et al., 1995) |
| Happiness | Questionnaire will be completed at day 0 and 6 weeks later. | French version of Subjective Happiness Scale (Lyubomirsky \& Lepper, 1997) |
| Satisfaction of life | Questionnaire will be completed at day 0 and 6 weeks later. | French version of The Satisfaction with Life Scale (Diener et al., 1985) |
| Prenatal Attachment | Questionnaire will be completed at day 0 and 6 weeks later. | French version of Prenatal Attachment Inventory, (Muller, 1993) |
| Sleep disorders | Questionnaire will be completed at day 0 and 6 weeks later. | French version of The Pittsburgh sleep quality index, (Buysse et al., 1989) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep disturbances | Questionnaires will be completed at 1 year Post partum | French Version Sleep disturbance scale for children, (Lecuelle et al., 2020) |
| Post natal attachment | video at 1 year | French version of Baby Interaction Scale (Beaupuy. 2021) Pediatric Infant Parent Exam (PIPE, Fiese et al., 2001) |
| Cries of the baby | Questionnaires will be completed daily up to 1 and 3 months post partum | French Version Colic infant questionnaire (Bellaiche et al., 2021) |
Countries
France
Outcome results
None listed