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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04660981
Other study ID # 2018.05.48
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2, 2019
Est. completion date May 15, 2020

Study information

Verified date December 2020
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 73
Est. completion date May 15, 2020
Est. primary completion date February 25, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility 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 Design


Intervention

Behavioral:
Antenatal education
Training Program on Fear of Childbirth Based on Motivational Interview Method

Locations

Country Name City State
Turkey Hacettepe University Faculty of Nursing Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe 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 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
Primary 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
Primary 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
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