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

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

Inclusion Criteria3

  • 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 Criteria3

  • 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.

Interested in this trial?

Get notified about updates and connect with the research team.

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

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.


Locations(1)

Alpes Maritimes, France

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12626000091303


Related Trials