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

December 3, 2020 updated by: Pelin Calpbinici, Hacettepe University

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: A Randomized Controlled Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
73

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Hacettepe University Faculty of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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
  • 24th and 28th weeks of pregnancy

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: İntervention Group
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
Training Program on Fear of Childbirth Based on Motivational Interview Method
NO_INTERVENTION: Control Group
No interventions were made for those in the control group other than routine hospital practices.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ) A version
Time Frame: 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
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)
Time Frame: 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 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
Time Frame: W-DEQ-B scores at postpartum first day
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 2, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 25, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018.05.48

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There are no plans.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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