Clinical trial NCT04097782: Effects of Antenatal Education on Fear of Birth, Depression, Anxiety, Childbirth Self-efficacy, and Mode of Delivery in Primiparous Pregnant Women
Official title: Effects of Antenatal Education on Fear of Birth, Depression, Anxiety, Childbirth Self-efficacy, and Mode of Delivery in Primiparous Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fear of Childbirth
Antenatal Education
Depression, Anxiety
Stress
Childbirth Self Efficacy
Mode of Delivery
Keywords: antenatal education
fear of childbirth
depression
anxiety
stress
childbirth self-efficacy
mode of delivery
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2019-09-20
Enrollment: 112
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background: Caesarean delivery rates are quite high, especially in primipara, in Turkey. Fear of birth, low childbirth self-efficacy, and psychological factors may be among the primary causes. Since antenatal educations are not universal and there are differences in educational contents, there is not sufficient evidence on this topic in international studies.

Objective: To investigate the effects of antenatal education on birth fear, depression, anxiety, stress, childbirth self-efficacy, and mode of delivery in primiparous pregnant women.

Detailed description: Background: Caesarean delivery rates are quite high, especially in primipara, in Turkey. Fear of birth, low childbirth self-efficacy, and psychological factors may be among the primary causes. Since antenatal educations are not universal and there are differences in educational contents, there is not sufficient evidence on this topic in international studies.

Objective: To investigate the effects of antenatal education on birth fear, depression, anxiety, stress, childbirth self-efficacy, and mode of delivery in primiparous pregnant women.

Design: A single-blind, prospective, randomized controlled trial. Setting and Participants: The study was conducted in a province in Central Anatolia region in Turkey, and the data were collected between April 2019 and September 2019. Randomized block assignment was used to assign 120 primiparous pregnant women to either the antenatal education group (n = 60) or the control group (n = 60). At the end of the study, 112 women were evaluated.

Measurements: Those in the antenatal education group received two-hour (240 min) educational sessions, twice a week, for 4 weeks. Data were collected by demographic and labor outcomes information form, The Wijma Delivery Expectancy/Experience Questionnaire (Version A and B), Childbirth Self-Efficacy Inventory, and the Depression, Anxiety and Stress Scale.

Eligibility criteria: Inclusion Criteria:

* Pregnant women (between 20 and 32 gestation weeks),
* Healthy,
* Nulliparous with singleton pregnancies,
* Older than 18 years.
* Involved giving birth at full term,
* Having a healthy newborn (born at 38-42 weeks of gestation)

Exclusion Criteria:

* Women taking medication for a diagnosed mental illness (e.g., antidepressants, antianxiety or antipsychotic medication),
* Women with complicated or high- risk pregnancies,
* Anticipating or experiencing a perinatal death (e.g., congenital abnormality incompatible) or stillbirth,
* Having experienced no postnatal complications (hemorrhage, puerperal infection, mastitis, thromboembolic disease or postpartum psychiatric disorder).

Primary outcomes:
measure: Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ-A)
timeFrame: Change from the Wijma Delivery Expectancy/Experience Questionnaire Version A scores at pre-education and post-education (4 weeks later).
measure: Childbirth Self-Efficacy Inventory (CBSEI)
timeFrame: Change from the Childbirth Self-efficacy Inventory scores at pre-education and post-education (4 weeks later).
measure: The depression anxiety and stress scale (DASS-21)
timeFrame: Change from the Depression Anxiety and Stress Scale scores at pre- education, post-education (4 weeks later) and postpartum 6-8 weeks.
measure: The Wijma Delivery Expectancy/Experience Questionnaire B version (W-DEQ-B)
timeFrame: Change from The Wijma Delivery Expectancy/Experience Questionnaire B version (W-DEQ-B) scores at postpartum 6-8 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
Study officials:
References:
citation: O'Connell MA, Khashan AS, Leahy-Warren P, Stewart F, O'Neill SM. Interventions for fear of childbirth including tocophobia. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD013321. doi: 10.1002/14651858.CD013321.pub2.