NCT07095088

Brief Summary

Nurses, who play a key role in maternal and infant health, take action with evidence-based practices to reduce fear of childbirth, encourage natural birth, and improve negative pre-pregnancy, pregnancy, and post-pregnancy outcomes caused by fear.Considering the increasing rates of elective cesarean sections in developed countries, interventions against fear of childbirth have become more important. The negative effects of cesarean section on both maternal and infant health and the damage it causes to the health system due to increased costs are clear . For all these reasons, the inclusion of awareness-based interventions such as MBCP in childbirth preparation class education programs not only aims to reduce the increasing cesarean section rates, but also aims to provide awareness that women and their partners can benefit from not only during pregnancy, birth, and parenthood, but throughout their lives.

Trial Health

55
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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

November 23, 2023

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 31, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2025

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2025

Completed
Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

1.8 years

First QC Date

June 23, 2025

Last Update Submit

July 23, 2025

Conditions

Keywords

birthchildbirth preparation classesmindfulnessmbcp

Outcome Measures

Primary Outcomes (1)

  • Mindful Attention Awareness Scale(MAAS) total score to assess change in trait mindfulness

    The MAAS is a 15-item self-report questionnaire developed by Brown \& Ryan (2003) and adapted into Turkish by Özyeşil et al. (2011). It measures the frequency of mindful states in daily life using a 6-point Likert scale (1 = Almost always to 6 = Almost never), with total scores ranging between 15 and 90. Higher scores reflect higher dispositional mindfulness. Unit of Measure: Total Score (15-90)

    Baseline (pre-intervention) and post-intervention (week 8)

Secondary Outcomes (2)

  • Wijma Delivery Expectancy Questionnaire (W-DEQ)total score to assess fear of childbirth

    Baseline (gestational week 28-30) and post-intervention (gestational week 36)

  • Visual Analog Scale (VAS)score to assess perceived labor pain

    IMMEDIATELY AFTER BIRTH

Study Arms (2)

Mindfulness-Based Childbirth and Parenting (MBCP)

EXPERIMENTAL

9 weeks of MBCP training will be provided.In addition to the 1-week birth preparation training at the Pregnancy School of Kayseri City Education and Research Hospital, the intervention group received Mindfulness-Based Parenting and Birth Preparation Training. This training aimed to teach participants how to monitor their thoughts and emotional states, how to deepen their sensory awareness of their bodies, how to be more careful about how their minds work, and how to deepen their sensory self-awareness, so that they would be more sensitive during the birth and parenting processes. A total of 9 separate sessions were implemented. Mindfulness-Based Parenting and Birth Preparation Training was held once a week for 9 weeks, with the duration of each session varying according to the parents' compliance and needs in the program, and each session lasted an average of 150 minutes.

Other: Mind-body therapy

clasical education

NO INTERVENTION

No additional training was given to the control group other than the 1-week birth preparation training at the Kayseri City Training and Research Hospital Pregnancy School.

Interventions

In addition to the 1-week birth preparation training at the Kayseri City Education and Research Hospital Pregnancy School, the intervention group received Mindfulness-Based Parenting and Birth Preparation Training. This training aimed to teach participants how to monitor their thoughts and emotional states, how to deepen their sensory awareness of their bodies, how to be more careful about how their minds work, and how to deepen their sensory self-awareness, so that they would be more sensitive during the birth and parenting processes. A total of 9 separate sessions were implemented. Mindfulness-Based Parenting and Birth Preparation Training was held once a week for 9 weeks, with the duration of each session varying according to the parents' compliance and needs in the program, and each session lasted an average of 150 minutes.

Mindfulness-Based Childbirth and Parenting (MBCP)

Eligibility Criteria

Age18 Years - 35 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsPregnant women and their spouses participated in the application
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 18-35,
  • Women in their first pregnancy,
  • Women in their 24-28th weeks of pregnancy,
  • Women accepted to Pregnancy School training during the study period,
  • Women with at least a literate education level, and
  • Women without a communication barrier were included in the study.

You may not qualify if:

  • \- • Women with psychiatric disorders,
  • Women with pregnancy-related risk factors that could lead to a risk of preterm birth,
  • Women with chronic illnesses that could lead to a risk of preterm birth were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kayseri Şehir Hastanesi

Kayseri, Kocasinan, 38080, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Interventions

Mind-Body Therapies

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: In this study, the experimental design of the quantitative research method was used. Quantitative research is a research that includes the process of observing and measuring numerical values objectively and systematically in order to obtain information about the current situation and facts, and the measurements can be repeated. Quantitative research focuses on the relationships and differences between variables, makes predictions about the future and has the aim of generalization. In quantitative research based on the positivism approach, hypotheses are clearly determined and tested. Since the research examined the effects of the awareness-based parenting and birth preparation training given in the birth preparation class on maternal-paternal attachment, birth parameters and postpartum sleep of a sample group that reached the power to represent the universe, the experimental design with a pre-test and post-test control.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Responsible Party Type: Principal Investigator, PhD student Name: Merve Gül Tiren

Study Record Dates

First Submitted

June 23, 2025

First Posted

July 31, 2025

Study Start

November 23, 2023

Primary Completion

September 20, 2025

Study Completion

October 10, 2025

Last Updated

July 31, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

güvenlikle ilgili şüphelerim var

Locations