Effect of Mindfulness Education in Primiparous Pregnant Women

Sponsor

T.C. ORDU ÜNİVERSİTESİ (Other)

Overall Status

Recruiting

CT.gov ID

NCT05250479

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Related Mindfulness Fear of Childbirth Attitude	Behavioral: Mindfulness education	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

88 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

Effect of Mindfulness Education on Fear of Childbirth, Mode of Delivery, Childbirth Experience and Prenatal and Maternal Attachment in Primiparous Pregnant Women

Actual Study Start Date :

Dec 20, 2021

Anticipated Primary Completion Date :

Dec 20, 2022

Anticipated Study Completion Date :

Jun 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control group 44 pregnant women won't receive mindfulness training
Experimental: experimental group "mindfulness education" mindfulness education 44 pregnant women will receive mindfulness training	Behavioral: Mindfulness education 44 primiparous pregnant women will receive mindfulness education

Arm

Intervention/Treatment

No Intervention: Control group

44 pregnant women won't receive mindfulness training

Experimental: experimental group "mindfulness education"

mindfulness education 44 pregnant women will receive mindfulness training

Behavioral: Mindfulness education

44 primiparous pregnant women will receive mindfulness education

Outcome Measures

Primary Outcome Measures

Wijma Delivery Expectancy/Experience Questionnaire A (W-DEQ A) [28-32. pregnant women]
determining the level fear of childbirth
Wijma Delivery Expectancy/Experience Questionnaire A (W-DEQ A) [After 32 weeks of pregnancy]
determining the level fear of childbirth
Prenatal Attachment Inventory [28-32. pregnant women]
determine prenatal mother-infant attachment
Prenatal Attachment Inventory [After 32 weeks of pregnancy]
determine prenatal mother-infant attachment

Secondary Outcome Measures

Maternal Fetal Attachment Scale [postpartum 1st month]
determine maternal fetal attachment
Wijma Delivery Expectancy/Experience Questionnaire B (W-DEQ B) [postpartum 1st month]
determining the level fear of childbirth

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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