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Prenatal Mindfulness Training for Maternal Behavior

N/A
Recruiting
Research Sponsored by Heidemarie Laurent
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pregnant women who are less than 28 weeks pregnant
Pregnant women who are between 18 and 40 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time 1 (20-28 weeks pregnancy) through time 3 (3 months postnatal)
Awards & highlights

Study Summary

This trial will investigate how prenatal mindfulness training can help mothers be present and experience compassionate love for their child. It will compare mothers who have completed the training to those without mindfulness training.

Who is the study for?
This trial is for pregnant women under 28 weeks along, expecting one baby, living near or willing to travel to the university's neuroimaging center. They must be aged 18-40, speak English, and have a certain level of worry as measured by a questionnaire.Check my eligibility
What is being tested?
The study compares Mindfulness-Based Childbirth and Parenting (MBCP), which trains expectant mothers in mindfulness for birthing and parenting, with standard childbirth education classes. It measures the impact on maternal presence and compassionate love through self-reports and brain scans.See study design
What are the potential side effects?
There are no direct side effects from participating in this study since it involves educational programs rather than medical treatments. However, participants may experience emotional discomfort when discussing personal topics during sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am pregnant and less than 28 weeks along.
Select...
I am a pregnant woman aged between 18 and 40.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time 1 (20-28 weeks pregnancy) through time 3 (3 months postnatal)
This trial's timeline: 3 weeks for screening, Varies for treatment, and time 1 (20-28 weeks pregnancy) through time 3 (3 months postnatal) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Compassion Scale
Five Facet Mindfulness Questionnaire
Inventory of Mindfulness in Parenting - Infant Measure
+3 more
Secondary outcome measures
Edinburgh Postnatal Depression Scale
Perceived Stress Scale

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness-Based Childbirth and Parenting (MBCP)Experimental Treatment1 Intervention
Child-bearers randomized to MBCP participate in the 9-week course with a partner (co-parenting partner or other support person who will be involved in the birth). During the training, mothers receive instruction in formal and informal mindfulness practices, and how these apply to the experience of childbirth and parenting an infant. Each weekly 3-hour class includes demonstration and discussion of a practice to be carried out at home over the coming week.
Group II: Treatment as Usual (TAU)Active Control1 Intervention
Child-bearers randomized to the treatment as usual comparison group participate (also with a partner) in a non-mindfulness-based childbirth class of their choice from a list provided. To maintain ecological validity of this treatment as usual condition, using an established comparative-effectiveness/pragmatic trial approach, no attempt is made to control the length or contact hours of the class.

Find a Location

Who is running the clinical trial?

Mind and Life Institute, Hadley, MassachusettsOTHER
15 Previous Clinical Trials
1,478 Total Patients Enrolled
Heidemarie LaurentLead Sponsor
University of Wisconsin, MadisonOTHER
1,187 Previous Clinical Trials
3,169,437 Total Patients Enrolled

Media Library

Mindfulness-Based Childbirth and Parenting Clinical Trial Eligibility Overview. Trial Name: NCT05241600 — N/A
Maternal-Fetal Relationship Research Study Groups: Mindfulness-Based Childbirth and Parenting (MBCP), Treatment as Usual (TAU)
Maternal-Fetal Relationship Clinical Trial 2023: Mindfulness-Based Childbirth and Parenting Highlights & Side Effects. Trial Name: NCT05241600 — N/A
Mindfulness-Based Childbirth and Parenting 2023 Treatment Timeline for Medical Study. Trial Name: NCT05241600 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cap for enrollment in this clinical evaluation?

"Affirmative. Clinicaltrials.gov attests to the fact that this research endeavour, initially made available on December 1st 2018, is currently looking for participants. Approximately 60 individuals are being sought from a single trial site."

Answered by AI

Are there any opportunities for patients to participate in this clinical trial presently?

"Clinicaltrials.gov confirms that this medical trial is actively accepting new participants, with the initial post being on December 1st 2018 and an update occurring on February 4th 2022."

Answered by AI

Who meets the qualifications for participation in this research study?

"This clinical trial is looking to enrol 60 pregnant women between the ages of 18 and 40 who are in a maternal-fetal relation. Furthermore, these participants must be no more than 28 weeks into their pregnancy, have an adequate comprehension of English (due to study measures not having been validated in other languages), possess Penn State Worry Questionnaire scores higher than 50, reside within forty miles from the university-affiliated neuroimaging centre or be willing to travel for videorecording sessions that include brain scanning if they live beyond forty miles away."

Answered by AI

Is this research endeavor open to participants of all ages, including those under 25?

"This trial can only accept patients aged between 18 and 40. For those below the age of consent or over 65, there are a total of 17 additional trials available for them to enrol in."

Answered by AI
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~1 spots leftby Jun 2024