NCT05250479

Brief Summary

While adaptation is generally achieved to the psychological changes that develop during pregnancy, some women may experience psychological changes such as contradiction, uncertainty, introversion, passive personality, addiction, fear, and anxiety in different periods of pregnancy. During this period, the fear of childbirth may also be experienced in pregnant women. Fear of childbirth or tokophobia is a phobic condition in which a woman avoids giving birth despite desperately wanting a baby. While fear of childbirth can have a negative impact on women's psychological health during pregnancy and birth experience, it is associated with negative obstetric outcomes and postpartum mental health problems. It is possible that the fear of childbirth reduces the mother's attachment to the fetus. Fear increases avoidant attachment and anxiety, which may be associated with lower commitment scores. There is a strong relationship between fear of childbirth and negative birth outcomes. Both affect the psychological well-being of the mother, adjustment to motherhood, and the quality of the mother's relationship with the baby. Knowing the fear of childbirth is important as it is associated with various health problems such as certain physiological and obstetric disorders and they can increase the possibility of emergency cesarean section. Mindfulness-based interventions combine elements of established cognitive behavioral therapy and psychoeducational content to support a self-effective approach to reduce stress-related symptoms and improve mental and physical well-being. Mindfulness-based practices that involve focusing on the present moment and accepting life without judgment are one of the effective ways to prepare for childbirth, help women feel more empowered and aware of their motherhood processes, and give mothers the opportunity to share knowledge and emotions. Mindfulness-based birth education intervention appears to be applicable for women and is associated with improvements in women's sense of control and confidence in giving birth.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

December 20, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 30, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 22, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2023

Completed
Last Updated

February 22, 2022

Status Verified

February 1, 2022

Enrollment Period

1 year

First QC Date

January 30, 2022

Last Update Submit

February 19, 2022

Conditions

Keywords

primiparouspregnant womenfear of childbirthprenatal attachmentmindfulness educationchildbirth experiencesmode of birthmaternal attachmentnursing

Outcome Measures

Primary Outcomes (4)

  • Wijma Delivery Expectancy/Experience Questionnaire A (W-DEQ A)

    determining the level fear of childbirth

    28-32. pregnant women

  • Wijma Delivery Expectancy/Experience Questionnaire A (W-DEQ A)

    determining the level fear of childbirth

    After 32 weeks of pregnancy

  • Prenatal Attachment Inventory

    determine prenatal mother-infant attachment

    28-32. pregnant women

  • Prenatal Attachment Inventory

    determine prenatal mother-infant attachment

    After 32 weeks of pregnancy

Secondary Outcomes (2)

  • Maternal Fetal Attachment Scale

    postpartum 1st month

  • Wijma Delivery Expectancy/Experience Questionnaire B (W-DEQ B)

    postpartum 1st month

Study Arms (2)

Control group

NO INTERVENTION

44 pregnant women won't receive mindfulness training

experimental group "mindfulness education"

EXPERIMENTAL

mindfulness education 44 pregnant women will receive mindfulness training

Behavioral: Mindfulness education

Interventions

44 primiparous pregnant women will receive mindfulness education

experimental group "mindfulness education"

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • over 18 years
  • in gestational week
  • First pregnancy
  • Understands and speaks Turkish
  • Single pregnancy
  • Having at least primary school education

You may not qualify if:

  • Having a high-risk pregnancy
  • Receiving psychotherapy or medication in the last six months before the study
  • with chronic disease Participating in childbirth preparation courses Planning a cesarean delivery with a diagnosed psychiatric illness Pregnant women with previous yoga and meditation experience Pregnant women with a high gestational age will be excluded from the study due to the possibility of giving birth before the end of the follow-up period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Recep Tayyip Erdogan University Training and Research Hospital

Rize, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Behavior

Study Officials

  • Nülüfer Erbil, PhD

    Ordu University

    STUDY DIRECTOR

Central Study Contacts

ÖZLEM AKIN, PhD student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, PhD student

Study Record Dates

First Submitted

January 30, 2022

First Posted

February 22, 2022

Study Start

December 20, 2021

Primary Completion

December 20, 2022

Study Completion

June 20, 2023

Last Updated

February 22, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations