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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04525430
Other study ID # 2017/4-3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2017
Est. completion date September 1, 2017

Study information

Verified date January 2022
Source Inonu University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The pregnant women constituting the sample were divided into 3 groups. Group 1 was given only childbirth education (Group-ED), group 2 was given childbirth education and was subjected to a birth plan (Group-ED&P), and group 3 was the control group, each including 51 pregnant women.


Description:

Aim: The purpose of this study was to investigate how pregnant women's childbirth self-efficacy was affected by childbirth education and birth plans applied with the education. Methods: The research was carried out at seven Family Health Centers in Turkey as a randomized controlled trial. The pregnant women constituting the sample were divided into 3 groups. Group 1 was given only childbirth education (Group-ED), group 2 was given childbirth education and was subjected to a birth plan (Group-ED&P), and group 3 was the control group, each including 51 pregnant women.


Recruitment information / eligibility

Status Completed
Enrollment 153
Est. completion date September 1, 2017
Est. primary completion date June 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility inclusion criteria: - pregnant women who was in the third trimester (28-40 gestational weeks), - who was literate or had a relative/helper who would write a birth plan to be prepared, - who were not involved in any diagnosed risk at the present pregnancy (such as preeclampsia, diabetes, heart disease, placenta previa, oligohydramnios and multiple pregnancy) - who did not have any diagnosed problems with the health of fetus (such as fetal anomaly and intrauterine growth retardation). exclusion criteria: • who had previous cesarean section were not included in the research.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
childbirth education
The 1st Session: General information about labor: Factors affecting labor, early signs of labor, signs of the start of labor, steps of labor, and procedures applied during labor. The 2nd Session: Methods of coping with birth contractions: Breathing exercises, relaxation exercises, massage, changing position, music, cold/warm application, focus, and walking.
childbirth education and was subjected to a birth plan
In the birth plan created by the researchers, the pregnant women considered the process from the start of labor to the end of labor and marked the expectation from and preferences about this process on the birth plan.

Locations

Country Name City State
Turkey Inönü University Malatya

Sponsors (1)

Lead Sponsor Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Aragon M, Chhoa E, Dayan R, Kluftinger A, Lohn Z, Buhler K. Perspectives of expectant women and health care providers on birth plans. J Obstet Gynaecol Can. 2013 Nov;35(11):979-985. doi: 10.1016/S1701-2163(15)30785-4. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in birth self-efficacy level at 2 weeks (after intervention). Childbirth Self-Efficacy was measured with Childbirth Self-Efficacy Inventory (CBSEI) Short Version. The scale consisted of two sub-dimensions, self-efficacy expectancy and outcome expectancy. The highest score to be taken from the sub-dimensions was 160, and the lowest score was 16. Pregnant women's having a high score on this scale meant that the level of their childbirth self-efficacy was high. CBSEI was administered as a pretest to all pregnant women in the three groups. After two weeks CBSEI was administered as a posttest to the pregnant women in all three groups.
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