NCT04097782

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 20, 2019

Completed
Last Updated

September 20, 2019

Status Verified

September 1, 2019

Enrollment Period

6 months

First QC Date

September 17, 2019

Last Update Submit

September 18, 2019

Conditions

Keywords

antenatal educationfear of childbirthdepressionanxietystresschildbirth self-efficacymode of delivery

Outcome Measures

Primary Outcomes (4)

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

    The W-DEQ Version A was developed by Wijma et al. (1998) in order to measure the fear of childbirth experienced by women during pregnancy. It is a six-point Likert-type scale and consists of 33 items. The responses given to the items on the scale are scored from 0 to 5, where 0 refers to 'extremely' and 5 refers to 'not at all'. The minimum and maximum possible scores to be obtained from the scale are 0 and 165, respectively. As the score increases, so does the fear of childbirth experienced by women (Wijma et al., 1998). Korukcu et al. (2012) examined the validity and reliability of the Turkish version of W-DEQ with women in the last trimester of pregnancy, and found a Cronbach׳s alpha of 0.89 and split-half reliability of 0.91.

    Change from the Wijma Delivery Expectancy/Experience Questionnaire Version A scores at pre-education and post-education (4 weeks later).

  • Childbirth Self-Efficacy Inventory (CBSEI)

    The short form of the Childbirth Self-efficacy Inventory has two subscales: outcome expectancy and efficacy expectancy (Ip, et al., 2008). Efficacy expectancy (EE) is a personal conviction about one's ability to successfully perform the required behaviors in a given situation, and outcome expectancy (OE) is the belief that a given behavior will lead to a given outcome. Each subscale consists of 16 items and yields a score between 16 and 160. Higher scores indicate higher levels of efficacy or outcome efficacy for birth. The CBSEI has strong psychometrics, with good internal consistency (α = 0.82) (Ip, et al., 2008). Psychometric properties of the Turkish version of the CBSEI were tested (Ersoy, 2011) and internal consistency was similarly high (α = 0.90).

    Change from the Childbirth Self-efficacy Inventory scores at pre-education and post-education (4 weeks later).

  • The depression anxiety and stress scale (DASS-21)

    The validity and reliability study of the Depression Anxiety Stress Scale (DASS-21), which was developed by Lovibond and Lovibond (1995), was conducted by Akın and Çetin (2007). The scale consists of 42 items. The scale has a four-point Likert-type rating: (0) Never, (1) Rarely, (2) Frequently, usually, and (4) Always. In the directive of DASS-21, individuals are asked to respond to each item based on how suitable it is for them considering the time period including the previous 30 days. There are 42 items in the DASS-21, 14 of which are related to depression, 14 anxiety, and 14 stress dimensions. The high scores obtained from each of the dimensions of depression, anxiety, and stress indicate that the individual has the relevant problem. The scale has no reverse item and the total score of the scale is expressed between 0 and 42 for each sub-dimension.

    Change from the Depression Anxiety and Stress Scale scores at pre- education, post-education (4 weeks later) and postpartum 6-8 weeks.

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

    The W-DEQ-B is a 33-item questionnaire with answers based on a 6-point Likert scale. The W-DEQ-B is used to determine fear during childbirth, and feelings and thoughts of postpartum women who had a vaginal childbirth. Total scores can range from 33 to 198, with higher scores indicative of more intense fear of childbirth in the postnatal period. Internal consistency and split-half reliability of the W-DEQ-B are ≥ 0.87 for samples of both nulliparous and multiparous women (Wijma et al., 1998). Reliability and validity studies of the W-DEQ-B were conducted in 2103 in Turkey by Uçar and Beji and the questionnaire's Cronbach's α value was found as 0.88.

    Change from The Wijma Delivery Expectancy/Experience Questionnaire B version (W-DEQ-B) scores at postpartum 6-8 weeks.

Study Arms (2)

Control Group

NO INTERVENTION

Prior to the study, primiparous pregnant women presented to the outpatient clinic for routine pregnancy control were introduced with free prenatal education classes and they were invited to participate in the study. Primiparous women who volunteered to participate in the study and met the inclusion criteria were included in the study and they formed the experimental and control group. Control group did not receive antenatal education and they received prenatal care service routinely provided at the polyclinics of the same hospital.

Experimental Group

EXPERIMENTAL

Antenatal education group The primiparous pregnant women assigned to the intervention group participated in education classes in groups of 8-10 people. Pregnant women were given structured antenatal education twice a week for two weeks (240 minutes). The total education time was 16 hours. Each session comprised 150 minutes presentation of theoretical knowledge, 45 minutes warm-up and stretching exercises, and 45 minutes relaxation exercises.

Behavioral: Antenat education

Interventions

Antenatal education group The primiparous pregnant women assigned to the intervention group participated in education classes in groups of 8-10 people. Pregnant women were given structured antenatal education twice a week for two weeks (240 minutes). The total education time was 16 hours. Each session comprised 150 minutes presentation of theoretical knowledge, 45 minutes warm-up and stretching exercises, and 45 minutes relaxation exercises.

Also known as: childbirth preparation training
Experimental Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University

Konya, 42050, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

September 17, 2019

First Posted

September 20, 2019

Study Start

April 1, 2019

Primary Completion

September 15, 2019

Study Completion

September 15, 2019

Last Updated

September 20, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations