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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05250479
Other study ID # ozlem20
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 20, 2021
Est. completion date June 20, 2023

Study information

Verified date February 2022
Source T.C. ORDU ÜNIVERSITESI
Contact ÖZLEM AKIN, PhD student
Phone 05416223058
Email akinozleem@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 88
Est. completion date June 20, 2023
Est. primary completion date December 20, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - over 18 years - 28-32. in gestational week - First pregnancy - Understands and speaks Turkish - Single pregnancy - Having at least primary school education Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Mindfulness education
44 primiparous pregnant women will receive mindfulness education

Locations

Country Name City State
Turkey Recep Tayyip Erdogan University Training and Research Hospital Rize

Sponsors (1)

Lead Sponsor Collaborator
T.C. ORDU ÜNIVERSITESI

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Wijma Delivery Expectancy/Experience Questionnaire A (W-DEQ A) determining the level fear of childbirth 28-32. pregnant women
Primary Wijma Delivery Expectancy/Experience Questionnaire A (W-DEQ A) determining the level fear of childbirth After 32 weeks of pregnancy
Primary Prenatal Attachment Inventory determine prenatal mother-infant attachment 28-32. pregnant women
Primary Prenatal Attachment Inventory determine prenatal mother-infant attachment After 32 weeks of pregnancy
Secondary Maternal Fetal Attachment Scale determine maternal fetal attachment postpartum 1st month
Secondary Wijma Delivery Expectancy/Experience Questionnaire B (W-DEQ B) determining the level fear of childbirth postpartum 1st month
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