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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04097782
Other study ID # 201920192019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2019
Est. completion date September 15, 2019

Study information

Verified date September 2019
Source Selcuk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 112
Est. completion date September 15, 2019
Est. primary completion date September 15, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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).

Study Design


Intervention

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.

Locations

Country Name City State
Turkey Selcuk University Konya

Sponsors (1)

Lead Sponsor Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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).
Primary 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 (a = 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 (a = 0.90). Change from the Childbirth Self-efficacy Inventory scores at pre-education and post-education (4 weeks later).
Primary 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 Akin 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.
Primary 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 a 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.
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