- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04525430
Childbirth Education and Birth Plan on Birth Self Efficacy in Pregnant Women
Comparison of Childbirth Education and Birth Plan With Childbirth Education Alone on Childbirth Self-Efficacy: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Malatya, Turkey
- Inonu University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
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: Group 1
only childbirth education group
|
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.
Other Names:
|
EXPERIMENTAL: Group 2
childbirth education and was subjected to a birth plan group
|
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.
Other Names:
|
NO_INTERVENTION: Group 3
standard care group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in birth self-efficacy level at 2 weeks (after intervention).
Time Frame: 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.
|
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.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: zeliha sunay, Msc, munzur üniversitesi
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2017/4-3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Pregnancy Related
-
4YouandMeCambridge Cognition Ltd; Sema4; Evidation Health; Vector Institute of Artificial... and other collaboratorsCompletedPregnancy Related | Wearables | Pregnancy EarlyUnited States
-
Helen Keller InternationalEleanor Crook FoundationNot yet recruitingPregnancy Related | Supplementation | Postnatal Related
-
The University of Texas Health Science Center,...CompletedPregnancy Related | Pregnancy, High RiskUnited States
-
Peking Union Medical College HospitalPeking Union Medical CollegeUnknownPregnancy | Pregnancy Related | Infant | Pregnancy Disease | Risk FactorChina
-
Shaare Zedek Medical CenterUnknownPregnancy Related | Pregnancy, High Risk | Anesthesia
-
University of CopenhagenStanford UniversityNot yet recruiting
-
European Vaccine InitiativeKintampo Health Research Centre, Ghana; Groupe de Recherche Action en Sante; Fondation... and other collaboratorsRecruitingPregnancy RelatedBenin, Burkina Faso, Ghana, Malawi
-
Kahramanmaras Sutcu Imam UniversityNot yet recruitingPregnancy RelatedTurkey
-
Fondation Hôpital Saint-JosephRecruiting
-
German Institute of Human NutritionRecruiting
Clinical Trials on childbirth education
-
University of Wisconsin, MadisonSuspended
-
Pamukkale UniversityCompletedCOVID-19 | Birth, First | Fear of ChildbirthTurkey
-
Endang Koni SuryaningsihCompleted
-
Taipei Medical UniversityCompleted
-
Selcuk UniversityCompletedStress | Depression, Anxiety | Fear of Childbirth | Mode of Delivery | Antenatal Education | Childbirth Self EfficacyTurkey
-
Çanakkale Onsekiz Mart UniversityCompleted
-
Amasya UniversityNot yet recruitingAnxiety | Pregnancy RelatedTurkey
-
Cukurova UniversityCompletedPregnancy | Fear | Education | Fear of Childbirth | BirthTurkey
-
Eunice Kennedy Shriver National Institute of Child...University of Pennsylvania; University of Alabama at Birmingham; Duke University and other collaboratorsRecruiting
-
University of ArkansasActive, not recruitingQuality of Life | Parent-Child Relations | Emotional Stress | Health Risk Behaviors | Childbirth Problems | Maternal Care Patterns | Health Care Acceptability | Health Problems in PregnancyUnited States