- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04660981
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
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
73
Phase
- 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
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Ankara, Turkey
- Hacettepe University Faculty of Nursing
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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
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 |
Intervention / Treatment |
---|---|
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.
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Training Program on Fear of Childbirth Based on Motivational Interview Method
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NO_INTERVENTION: Control Group
No interventions were made for those in the control group other than routine hospital practices.
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What is the study measuring?
Primary Outcome Measures
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.
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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
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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
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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.
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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
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The Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ) B version
Time Frame: W-DEQ-B scores at postpartum first day
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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.
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W-DEQ-B scores at postpartum first day
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
August 2, 2019
Primary Completion (ACTUAL)
February 25, 2020
Study Completion (ACTUAL)
May 15, 2020
Study Registration Dates
First Submitted
November 25, 2020
First Submitted That Met QC Criteria
December 3, 2020
First Posted (ACTUAL)
December 9, 2020
Study Record Updates
Last Update Posted (ACTUAL)
December 9, 2020
Last Update Submitted That Met QC Criteria
December 3, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Other Study ID 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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