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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 17, 2019
First Posted Date  ICMJE September 20, 2019
Last Update Posted Date September 20, 2019
Actual Study Start Date  ICMJE April 1, 2019
Actual Primary Completion Date September 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2019)
  • 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.
  • 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).
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Antenatal Education on Fear of Birth, Depression, Anxiety, Childbirth Self-efficacy, and Mode of Delivery in Primiparous Pregnant Women
Official Title  ICMJE Effects of Antenatal Education on Fear of Birth, Depression, Anxiety, Childbirth Self-efficacy, and Mode of Delivery in Primiparous Pregnant Women
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Fear of Childbirth
  • Antenatal Education
  • Depression, Anxiety
  • Stress
  • Childbirth Self Efficacy
  • Mode of Delivery
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Antenat education
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 18, 2019)
112
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 15, 2019
Actual Primary Completion Date September 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04097782
Other Study ID Numbers  ICMJE 201920192019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party seyhan Çankaya, Selcuk University
Study Sponsor  ICMJE Selcuk University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Selcuk University
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP