NCT04660981

Brief Summary

This two-group, parallel randomized controlled study was conducted to evaluate the effect of the training program provided to primipara pregnant women through the motivational interview method on their fear of childbirth, childbirth self-efficacy and delivery mode. The primipara pregnant women included in the study sample were assigned to the intervention (n=37) and control (n=36) groups using the block randomization method. The women in the intervention group were individually provided with "Training Program on Fear of Childbirth Based on Motivational Interview Method" once a week, four sessions in total, while no interventions were made for those in the control group other than routine hospital practices. Study data were collected using a descriptive information form, the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ) versions A-B, the Childbirth Self-Efficacy Inventory-Short Form (CBSEI-SF) and the Delivery Evaluation Form. The value of p\<0.05 was accepted statistically significant in the data analyses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 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

August 2, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 9, 2020

Completed
Last Updated

December 9, 2020

Status Verified

December 1, 2020

Enrollment Period

7 months

First QC Date

November 25, 2020

Last Update Submit

December 3, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

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

    W-DEQ Version A, which was developed in Sweden in 1998 by Wijma and Klaas, was adapted into Turkish by Körükçü et al. in 2009. It is a 6-point Likert type scale and consists of 33 items. The answers in the scale are scored from 0 to 5, with 0 indicating "completely" and 5 indicating "none." The minimum score on the scale is 0, whereas the maximum score is 165. A high total score indicates a high level of fear; 85 points are considered as the cut-off value. A score of ≥85 indicates clinical level fear.

    Change from the WDEQ A scores at pre-training (24th and 28th gestational week), post-training (4 weeks later) and 37th and 40th gestational week

  • Childbirth Self-Efficacy Inventory-Short Form (CBSEI-SF)

    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.

    Change from the CBSEI-SF scores at pre-training (24th and 28th gestational week), post-training (4 weeks later) and 37th and 40th gestational week

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

    The W-DEQ-B was created by Wijma and et al. to evaluate intrapartum childbirth fear in the postpartum period. The validity and reliability study of the scale was conducted by Körükçü et al. It is composed of 32 items. It uses a 6-point Likert scale: 0 corresponds to completely, and 5 corresponds to never. The lowest and the highest scores for the scale are 0 and 160, respectively.

    W-DEQ-B scores at postpartum first day

Study Arms (2)

İntervention Group

EXPERIMENTAL

The women in the intervention group were individually provided with "Training Program on Fear of Childbirth Based on Motivational Interview Method" once a week, four sessions in total.

Behavioral: Antenatal education

Control Group

NO INTERVENTION

No interventions were made for those in the control group other than routine hospital practices.

Interventions

Training Program on Fear of Childbirth Based on Motivational Interview Method

İntervention Group

Eligibility Criteria

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

You may qualify if:

  • Ability to read and write in Turkish
  • Not contraindicated for vaginal delivery
  • Absence of any pregnancy-related complications
  • Absence of chronic systemic disease
  • Absence of communication problems
  • Absence of psychiatric problems
  • No abnormalities in the fetus
  • th and 28th weeks of pregnancy

You may not qualify if:

  • Premature birth (before 37th weeks of gestation)
  • Pregnancy complication developed at any stage of the study (such as preeclampsia, placenta previa, oligohydramnios, gestational diabetes)
  • A cesarean section is planned at any stage of the study due to a medical indication,
  • Did not complete the training program
  • Giving birth outside the province
  • Not seen within 24 hours after birth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University Faculty of Nursing

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Prenatal Education

Intervention Hierarchy (Ancestors)

Patient Education as TopicHealth EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

November 25, 2020

First Posted

December 9, 2020

Study Start

August 2, 2019

Primary Completion

February 25, 2020

Study Completion

May 15, 2020

Last Updated

December 9, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

There are no plans.

Locations