NCT05584618

Brief Summary

The aim of this study was to investigate the effects of antenatal education on birth fear, depression, anxiety, stress, maternal 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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

3 active sites

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

First Submitted

Initial submission to the registry

October 1, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 18, 2022

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

1 month

First QC Date

October 1, 2022

Last Update Submit

November 8, 2023

Conditions

Keywords

antenatal educationfear of childbirthdepression, anxietystressmaternal self-efficacymode of delivery

Outcome Measures

Primary Outcomes (8)

  • Perceived Stress Scale (PSS)

    The scale developed by Cohen, Kamarck and Mermelstein (1983) and its Turkish adaptation was carried out by Eskin, Harlak, Demirkıran and Dereboy (2013), which aims to measure how stressful some situations in a person's life are perceived, consists of 14 items. The "Perceived Stress Scale" consists of the dimensions of "Perception of Inadequate Self-Efficacy" and "Perception of Stress/Discomfort". Participants evaluated each item on a 5-point Likert-type scale ranging from "Never (0)" to "Very often (4)". The internal consistency coefficient of the Turkish scale was 0.84 and the test-retest reliability was 0.87.

    at 20 to 36 weeks gestational age

  • Perceived Stress Scale (PSS)

    The scale developed by Cohen, Kamarck and Mermelstein (1983) and its Turkish adaptation was carried out by Eskin, Harlak, Demirkıran and Dereboy (2013), which aims to measure how stressful some situations in a person's life are perceived, consists of 14 items. The "Perceived Stress Scale" consists of the dimensions of "Perception of Inadequate Self-Efficacy" and "Perception of Stress/Discomfort". Participants evaluated each item on a 5-point Likert-type scale ranging from "Never (0)" to "Very often (4)". The internal consistency coefficient of the Turkish scale was 0.84 and the test-retest reliability was 0.87.

    6-8 weeks postpartum

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

    The scale was developed by Klaas and Barbro Wijma to measure the fear of childbirth and its Turkish adaptation and validity and reliability were conducted by Körükçü, Kukulu, and Fırat (2012, 2018). The scale consists of 33 items and the answers are enumerated between 0 and 5 as a 6-item liker scale, in which 0 means "completely" and 5 means "none". The range of the total score of the scale is between 0 and 165. The higher the scores, the higher the fear of birth experienced by women

    at 20 to 36 weeks gestational age

  • Multidimensional Scale of Perceived Social Support (MSPSS)

    The scale developed by Zimet et al. in 1988 and Turkish adaptation, validity and reliability studies were carried out by Eker, Arkar, and Yaldız (2001). The MSPSS is a 12-item scale, and includes 3 groups about the source of support, each of which consisting of 4 items, which are family, friend, and a special person. In the Cronbach's Alpha Method that was used to measure the internal consistency, values were found to be between 0.80 and 0.95

    at 20 to 36 weeks gestational age

  • Multidimensional Scale of Perceived Social Support (MSPSS)

    The scale developed by Zimet et al. in 1988 and Turkish adaptation, validity and reliability studies were carried out by Eker, Arkar, and Yaldız (2001). The MSPSS is a 12-item scale, and includes 3 groups about the source of support, each of which consisting of 4 items, which are family, friend, and a special person. In the Cronbach's Alpha Method that was used to measure the internal consistency, values were found to be between 0.80 and 0.95

    6-8 weeks postpartum

  • Warwick-Edinburgh Mental Well-being Scale (WEMWBS)

    The Turkish adaptation of the scale, developed in 2007 by Tennant et al., was done by Keldal in 2015. It is a five-point Likert-type scale, including 14 items. The lowest and the highest scores are 14 and 70 points. High scores indicate high mental wellbeing. Cronbach's alpha value of the scale was determined as 0.89

    at 20 to 36 weeks gestational age

  • Warwick-Edinburgh Mental Well-being Scale (WEMWBS)

    The Turkish adaptation of the scale, developed in 2007 by Tennant et al., was done by Keldal in 2015. It is a five-point Likert-type scale, including 14 items. The lowest and the highest scores are 14 and 70 points. High scores indicate high mental wellbeing. Cronbach's alpha value of the scale was determined as 0.89

    6-8 weeks postpartum

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

    W-DEQ- B was developed by Wijma et al. to determine postpartum feelings and thoughts about the fear of women who gave vaginal birth (1998). The scale consists of a total of 33 6-point Likert-type questions. Each item is defined as 1 with a score between 1-6 and 6 as none. The minimum score on the scale is 33, while the maximum score is 198. The higher the scores, the higher the fear of birth experienced by women

    6-8 weeks postpartum

Study Arms (2)

intervention

EXPERIMENTAL

The women allocated in experimental group will be given antenatal education for 6 weeks

Other: Education

control

NO INTERVENTION

The women allocated for the control group will receive prenatal care services routinely provided at the outpatient clinics of the same hospital

Interventions

education

intervention

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Literate
  • Childbirth at fullterm (born at 38-42 weeks)
  • Nulliparous women
  • Women between the ages of 18-35
  • Singleton pregnancy in 20 and 36 weeks of gestation
  • Having a healthy newborn
  • No participation in another prenatal program
  • Absence of any psychiatric illness or comorbidities
  • No use medications for a diagnosed mental disorder
  • Baby with normal birth weight and APGAR score of 8 and above
  • Women who have not developed postpartum complications
  • Women without complicated/high-risk pregnancies, who do not experience a perinatal death or stillbirth
  • Speaks and understands Turkish
  • Women with a total fear of childbirth score W-DEQ-A ≥60 will be included.
  • Women who give birth through vaginal route

You may not qualify if:

  • Women who do not meet the sample selection criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Saglık Bilimleri Universitesi

Istanbul, 34668, Turkey (Türkiye)

Location

Zeynep Kamil Women's and Children's Diseases Training and Research Hospital

Istanbul, 34668, Turkey (Türkiye)

Location

Kartal Dr.Lütfi Kırdar City Hospital

Istanbul, 34865, Turkey (Türkiye)

Location

MeSH Terms

Conditions

DepressionAnxiety Disorders

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Leyla Kaya, PhD

    Zeynep Kamil Women and Children's Diseases Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 1, 2022

First Posted

October 18, 2022

Study Start

October 1, 2022

Primary Completion

November 1, 2022

Study Completion

October 31, 2023

Last Updated

November 9, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations