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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000091303
Enrollment
50
Registered
2026-01-23
Start date
2023-03-31
Completion date
2026-03-31
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 med

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.

Sponsors

Beauvois Clara - Université Côte d'Azur
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No

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

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Jul 10, 2026