Pregnant WomenNCT04897906
The Effect of Education Given to Primiparous Pregnant Women on Parental Self-Efficacy and Mother-Infant Attachment
A study testing Education Group in people with Pregnant Women, run by University of Beykent at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Women
- What is being tested?
- Education Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 May 2021to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being at 36-40 weeks of gestation
- Being her first pregnancy
- Being literate
- Being over the age of 18
Who cannot join
- Not in the 36-40 gestational week
- Not a first pregnancy
- Illiterate
- Under 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pregnant Women
- Being tested
- Education Group
- Keywords
- Pregnancy, Mother-Infant Attachment, Parental Self-Efficacy, Education Pregnant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education GroupBehavioural
Mother care, newborn care and breastfeeding education will be provided to pregnant women in the third trimester of pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Experimental group; It is the group that will be given mother and neonatal care education. Receives: Behavioral: Education Group |
| Control Group | No intervention | Control group; It is the group in which no intervention will be made other than data collection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental self-efficacy in postpartum period of pregnant women who received education during pregnancy
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.
Measured: Mothers will be evaluated within 30-40 days after birth.
Mother-Infant attachment in postpartum period of pregnant women who received education during pregnancy
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.
Measured: Mothers will be evaluated within 30-40 days after birth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start12 May 2021
- Primary completion30 Jul 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pregnant women included in the research sample will be divided into two groups as experimental and control groups. Experimental group; is the group to be trained. Control group; It is the group in which no intervention will be made other than data collection.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Beykent
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Principal investigator, Cisem Bastarcan, University of Beykent
- Investigators
- Cisem Bastarcan, MsC, Principal investigator, Research Assistant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04897906
- Sponsor's protocol ID
- CBastarcan
- Status last verified
- Jan 2023
- First submitted
- 18 May 2021
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education Given to Primiparous Pregnant Women on Parental Self-Efficacy and Mother-Infant Attachment
- ClinicalTrials.gov ID
- NCT04897906
- Acronym / sponsor ID
- CBastarcan
- Conditions
- Pregnant Women
- Keywords
- Pregnancy, Mother-Infant Attachment, Parental Self-Efficacy, Education Pregnant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of BeykentUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 12 May 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 24 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pregnant women included in the research sample will be divided into two groups as experimental and control groups. Experimental group; is the group to be trained. Control group; It is the group in which no intervention will be made other than data collection.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Education GroupExperimental group; It is the group that will be given mother and neonatal care education. |
| Control Group | No intervention | –Control group; It is the group in which no intervention will be made other than data collection. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Being at 36-40 weeks of gestation
- Being her first pregnancy
- Being literate
- Being over the age of 18
Key exclusion criteria (4 listed)
- Not in the 36-40 gestational week
- Not a first pregnancy
- Illiterate
- Under 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education GroupMother care, newborn care and breastfeeding education will be provided to pregnant women in the third trimester of pregnancy. | Behavioural | Experimental group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cisem Bastarcan, MsC principal investigator
Research Assistant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education Group in people with Pregnant Women, run by University of Beykent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2023.