Effect of Mindfulness Education in Primiparous Pregnant Women
1 other identifier
interventional
88
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 20, 2021
CompletedFirst Submitted
Initial submission to the registry
January 30, 2022
CompletedFirst Posted
Study publicly available on registry
February 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2023
CompletedFebruary 22, 2022
February 1, 2022
1 year
January 30, 2022
February 19, 2022
Conditions
Keywords
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 INTERVENTION44 pregnant women won't receive mindfulness training
experimental group "mindfulness education"
EXPERIMENTALmindfulness education 44 pregnant women will receive mindfulness training
Interventions
44 primiparous pregnant women will receive mindfulness education
Eligibility Criteria
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
- Ordu Universitylead
Study Sites (1)
Recep Tayyip Erdogan University Training and Research Hospital
Rize, Turkey (Türkiye)
MeSH Terms
Conditions
Study Officials
- STUDY DIRECTOR
Nülüfer Erbil, PhD
Ordu University
Central Study Contacts
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