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Effects of Antenatal Education on Fear of Birth, Depression, Anxiety, Childbirth Self-efficacy, and Mode of Delivery in Primiparous Pregnant Women (Antenatal)

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ClinicalTrials.gov Identifier: NCT04097782
Recruitment Status : Completed
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
seyhan Çankaya, Selcuk University

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.


Condition or disease Intervention/treatment Phase
Fear of Childbirth Antenatal Education Depression, Anxiety Stress Childbirth Self Efficacy Mode of Delivery Behavioral: Antenat education Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Effects of Antenatal Education on Fear of Birth, Depression, Anxiety, Childbirth Self-efficacy, and Mode of Delivery in Primiparous Pregnant Women
Actual Study Start Date : April 1, 2019
Actual Primary Completion Date : September 15, 2019
Actual Study Completion Date : September 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Childbirth

Arm Intervention/treatment
No Intervention: Control Group

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: Experimental Group
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
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.
Other Name: childbirth preparation training




Primary Outcome Measures :
  1. Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ-A) [ Time Frame: Change from the Wijma Delivery Expectancy/Experience Questionnaire Version A scores at pre-education and post-education (4 weeks later). ]
    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.

  2. Childbirth Self-Efficacy Inventory (CBSEI) [ Time Frame: Change from the Childbirth Self-efficacy Inventory scores at pre-education and post-education (4 weeks later). ]
    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).

  3. The depression anxiety and stress scale (DASS-21) [ Time Frame: Change from the Depression Anxiety and Stress Scale scores at pre- education, post-education (4 weeks later) and postpartum 6-8 weeks. ]
    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.

  4. The Wijma Delivery Expectancy/Experience Questionnaire B version (W-DEQ-B) [ Time Frame: Change from The Wijma Delivery Expectancy/Experience Questionnaire B version (W-DEQ-B) scores at postpartum 6-8 weeks. ]
    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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04097782


Locations
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Turkey
Selcuk University
Konya, Turkey, 42050
Sponsors and Collaborators
Selcuk University

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Responsible Party: seyhan Çankaya, Assistant professor, Selcuk University
ClinicalTrials.gov Identifier: NCT04097782     History of Changes
Other Study ID Numbers: 201920192019
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by seyhan Çankaya, Selcuk University:
antenatal education
fear of childbirth
depression
anxiety
stress
childbirth self-efficacy
mode of delivery
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders