- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04897906
The Effect of Education Given to Primiparous Pregnant Women on Parental Self-Efficacy and Mother-Infant Attachment
This research will be carried out in a quasi-experimental design to determine the effect of maternity care and neonatal care training given to primiparous pregnant women on parental self-efficacy and mother-infant attachment in the postpartum period.
Research Hypotheses:
H0: There is no difference in parental self-efficacy and mother-infant attachment in the postpartum period between pregnant women who received training during pregnancy and did not.
H1: There is a difference in parental self-efficacy and mother-infant attachment in the postpartum period between pregnant women who received and did not receive education during pregnancy.
Study Overview
Detailed Description
The number of people to be included in the study was made with the power analysis made considering the previous studies. With the G * Power (3.1.9.7.) Program, the number of samples for each group was determined as n = 34 at 80% power, 5% error and 95% confidence interval. Considering the losses in data collection, 20% was added to each group and it was decided to recruit a total of 80 people, 40 people for the experimental group and 40 people for the control group.
Pregnant women included in the research sample will be divided into two groups as experimental and control groups. Data will be collected by sending via an online questionnaire created by the researchers. Before the online questionnaire is sent to the experimental and control groups, the experimental-control days will be determined randomly by a lottery drawn by a third person (blinding). Pregnant women who agree to participate in the study will be assigned to the experimental and control groups according to the determined days.
The data obtained in the study will be analyzed using the SPSS (Statistical Package for Social Sciences) for Windows 22.0 program. Significance value will be considered as p <0.05.
Number, percentage, mean and standard deviation will be used as descriptive statistical methods in the evaluation of data. Pearson correlation and regression analysis will be applied among the continuous variables of the study. The t-test will be used to compare the quantitative continuous data between two independent groups, and the One-way Anova test will be used to compare the quantitative continuous data between more than two independent groups. After the Anova test, the Scheffe test will be used as a complementary post-hoc analysis to determine the differences.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Istanbul
-
Buyukcekmece, Istanbul, Turkey
- Beykent University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Being at 36-40 weeks of gestation
- Being her first pregnancy
- Being literate
- Being over the age of 18
Exclusion Criteria:
- Not in the 36-40 gestational week
- Not a first pregnancy
- Illiterate
- Under 18 years old
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group
Experimental group; It is the group that will be given mother and neonatal care education.
|
Mother care, newborn care and breastfeeding education will be provided to pregnant women in the third trimester of pregnancy.
|
|
No Intervention: Control Group
Control group; It is the group in which no intervention will be made other than data collection.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parental self-efficacy in postpartum period of pregnant women who received education during pregnancy
Time Frame: Mothers will be evaluated within 30-40 days after birth.
|
Parental Self-Efficacy Scale will be used in the evaluation.
It is a scale developed to determine the personal beliefs of new parents about their competencies in their roles.
|
Mothers will be evaluated within 30-40 days after birth.
|
|
Mother-Infant attachment in postpartum period of pregnant women who received education during pregnancy
Time Frame: Mothers will be evaluated within 30-40 days after birth.
|
Maternal Attachment Scale will be used in evaluation.
It was developed to measure the mother's love and attachment to her baby.
Higher scores on the scale indicate higher maternal attachment.
|
Mothers will be evaluated within 30-40 days after birth.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Cisem Bastarcan, MsC, Research assistant
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 (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CBastarcan
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.
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