NCT06111716

Brief Summary

The study was conducted as a prospective, randomized controlled study to determine the effect of Mindfulness-Based Childbirth Education on psychosocial outcomes in pregnant women. Pregnant women applied to Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Department of Obstetrics and Gynecology, Pregnancy Polyclinic and Faculty Member Polyclinic between 15.09.2021-28.06.2022. A total of 82 pregnant women were included in the experimental and control groups. The experimental group received Mindfulness-Based Childbirth Education for 8 weeks and the control group received Information-Based Childbirth Education for 4 weeks. Evaluation was performed in both groups before and after the training and at the end of the 4th postpartum week. The data were collected using the Introductory Information Form, Perceived Stress Scale, Edinburg Postpartum Depression Scale, Birth Self-Efficacy Scale and City Birth Trauma Scale.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 1, 2023

Completed
Last Updated

November 1, 2023

Status Verified

October 1, 2023

Enrollment Period

10 months

First QC Date

October 21, 2023

Last Update Submit

October 31, 2023

Conditions

Keywords

MindfulnessDepressionPregnant WomenChildbirth EducationSelf-efficacyPostpartum trauma

Outcome Measures

Primary Outcomes (4)

  • Perceived Stress

    The perceived stress level of pregnant women before and after the training was evaluated. Perceived stress level was re-evaluated at the 4th week postpartum. "Perceived Stress Scale (PSS)" was used to evaluate the perceived stress level. Perceived Stress Scale consists of a total of 14 items and evaluates individuals' stress perceptions against certain situations they encounter in their lives. The scale has a five-point Likert rating. The scale has two subscales called "perception of insufficient self-efficacy" and "perception of stress/discomfort".The lowest score that can be obtained from PSS-14 is 0 and the highest score is 56. An increase in the scores people get from the scale indicates that their perception of stress increases.

    from the beginning of the study to the fourth week postpartum

  • Self-Efficacy in Labor

    Self-efficacy levels of pregnant women were evaluated before and after the training. A total of 2 measurements were made. "Self-Efficacy in Childbirth Scale" was used to assess the level of self-efficacy. The Self-Efficacy in Childbirth Scale evaluates women's self-efficacy level regarding childbirth. The scale has two subscales. The minimum score that can be obtained from each subscale is 16 and the maximum score is 160. The minimum score that can be obtained from the whole scale is 32 and the maximum total score is 320. Higher scores obtained from the scale indicate that pregnant women have higher levels of self-efficacy for childbirth.

    From the beginning of the study to the end of training and birth

  • Edinburgh Postpartum Depression Incidence

    The depression symptoms of the pregnant women were evaluated 3 times in total, before, after and at the fourth week after delivery. Edinburgh Postpartum Depression Scale was used in the evaluation. Self-efficacy levels of pregnant women were evaluated before and after the training. A total of 2 measurements were made. The "Self-Efficacy in Childbirth Scale" was used to assess the level of self-efficacy. The Self-Efficacy in Childbirth Scale evaluates women's self-efficacy level regarding childbirth. The scale has two subscales. The minimum score that can be obtained from each subscale is 16 and the maximum score is 160. The minimum score that can be obtained from the whole scale is 32 and the maximum total score is 320. Higher scores obtained from the scale indicate that pregnant women have higher levels of self-efficacy for childbirth.

    From the beginning of the study (pre-training) to the fourth week postpartum.

  • Symptoms of post traumatic stretch disorder

    Postpartum posttraumatic stress disorder (PTSD) symptoms were assessed only at the fourth postpartum week using the City Birth Trauma Scale. The four-point Likert-type scale consists of 29 items and five subscales. The sub-dimensions are re-experiencing, avoidance symptoms, negative cognitions and mood, hyperarousal and dissociative symptoms. The City Birth Trauma Scale is used to assess symptoms of Posttraumatic Stress Disorder (PTSD) and is not a diagnostic tool. A higher score on the scale means that posttraumatic stress symptoms are more prevalent and reflects a greater risk for Posttraumatic Stress Disorder (PTSD).

    In the fourth week postpartum

Study Arms (2)

Information-Based Childbirth Education Group

ACTIVE COMPARATOR

Information-Based Birth Preparation Education Content; "Physical and mental preparation for birth, the birth process, non-pharmacological methods that reduce birth pain and facilitate birth, postpartum period characteristics, physiological and psychological effects on the mother after birth."It includes topics such as "changes, adaptation to the maternal role, newborn care". Education is information-based, not based on a philosophy or model.

Other: Information-Based Birth Education

Mindfulness-Based Childbirth Education Group

EXPERIMENTAL

Mindfulness-Based Childbirth Education includes topics related to birth as well as mindfulness, mindfulness attitudes and practices, mindfulness in daily life, mindfulness during pregnancy and postpartum period, mindfulness breastfeeding and meditation practices. The training duration is 8 weeks (2 hours each week).

Other: Mindfulness- Based Childbirth Education

Interventions

Mindfulness- Based Childbirth Education Group includes; Women were given eight-week birth preparation training. In this training, in addition to information about birth, mindfulness, mindfulness attitudes and practices, mindfulness in daily life, mindfulness in pregnancy and postpartum period, mindfulness breastfeeding and meditation practices were included.

Mindfulness-Based Childbirth Education Group

In the Information-Based Birth Education Group, women were given 4-week (4 hours per week) birth preparation training. The education given was not based on a philosophy or method.

Information-Based Childbirth Education Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being at least 18 years old
  • Being primiparous
  • To be at least primary school graduate,
  • Not having a risky pregnancy,
  • Being between 20-26 weeks of pregnancy,
  • Those who volunteered to participate in the study,
  • Having internet access and equipment (computer, smart phone, etc.).

You may not qualify if:

  • Being multiparous
  • To have taken yoga or mindfulness training during pregnancy or before,
  • Pregnant women with communication problems (related to hearing, speaking and understanding),
  • Receiving psychiatric treatment during pregnancy or postpartum period.
  • Pregnant women who want to leave the study,
  • Those who were diagnosed with risky pregnancy during the research (preeclampsia, threat of premature birth, etc.),
  • Pregnant women who do not attend 70% of the education.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Çanakale Onsekiz Mart University

Çanakkale, 17000, Turkey (Türkiye)

Location

Related Publications (4)

  • Duncan LG, Cohn MA, Chao MT, Cook JG, Riccobono J, Bardacke N. Benefits of preparing for childbirth with mindfulness training: a randomized controlled trial with active comparison. BMC Pregnancy Childbirth. 2017 May 12;17(1):140. doi: 10.1186/s12884-017-1319-3.

    PMID: 28499376BACKGROUND
  • Lonnberg G, Jonas W, Unternaehrer E, Branstrom R, Nissen E, Niemi M. Effects of a mindfulness based childbirth and parenting program on pregnant women's perceived stress and risk of perinatal depression-Results from a randomized controlled trial. J Affect Disord. 2020 Feb 1;262:133-142. doi: 10.1016/j.jad.2019.10.048. Epub 2019 Oct 30.

  • Duncan LG, Bardacke N. Mindfulness-Based Childbirth and Parenting Education: Promoting Family Mindfulness During the Perinatal Period. J Child Fam Stud. 2010 Apr;19(2):190-202. doi: 10.1007/s10826-009-9313-7. Epub 2009 Oct 10.

  • Fisher C, Hauck Y, Bayes S, Byrne J. Participant experiences of mindfulness-based childbirth education: a qualitative study. BMC Pregnancy Childbirth. 2012 Nov 13;12:126. doi: 10.1186/1471-2393-12-126.

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • sibel Ocak Akturk

    Çanakkale Onsekiz Mart University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Mindfulness-Based Childbirth Education was implemented in the intervention group Information-Based Birth Education was applied to the control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 21, 2023

First Posted

November 1, 2023

Study Start

September 15, 2021

Primary Completion

June 28, 2022

Study Completion

March 13, 2023

Last Updated

November 1, 2023

Record last verified: 2023-10

Locations