- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07547579
The Effect of Neonatal Care Education Given to Primiparous Mothers in the Last Trimester on Mothers' Self-Efficacy Perception, Prenatal and Maternal Bonding in the Early Postpartum Period
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Merkez
-
Kars, Merkez, Turkey (Türkiye), 36100
- Kafkas Üniversitesi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Being over 18 and under 35 years of age, Being in the last trimester of pregnancy (28-32 weeks of gestation) Having no communication barriers and being literate Single pregnancy Spontaneous conception Having applied to the Kars Harakani State Hospital Pregnancy School Agreeing to participate in the study
Exclusion Criteria:
Chronic illness, High-risk pregnancy, Having a psychological disorder, Having applied to a Pregnancy School other than Harakani State Hospital.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Intervention Group Intervention Type: Behavioral Name: Newborn Care Education Group
Primiparous women in their third trimester assigned to the intervention group will receive a structured newborn care education program in addition to completing the study questionnaires.
|
The newborn care education program includes information on breastfeeding, infant hygiene, umbilical cord care, infant safety, and basic newborn care practices. The education is provided during the third trimester of pregnancy. Allocation / Randomization Allocation: Randomized Randomization Description: Participants will be randomly assigned to the intervention group or the control group using a computer-generated randomization sequence with a 1:1 allocation ratio. Masking (Blinding) Masking: None (Open Label) Masking Description (opsiyonel): This is an open-label study. Participants and investigators are aware of group assignment. |
|
No Intervention: Control Group
Primiparous women assigned to the control group will receive routine prenatal care and will complete the study questionnaires only.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
General Self-Efficacy
Time Frame: (between 24 and 41 weeks of pregnancy)
|
Changes in maternal self-efficacy levels measured using the General Self-Efficacy Scale during the early postpartum period.
|
(between 24 and 41 weeks of pregnancy)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prenatal Attachment
Time Frame: (between 24 and 41 weeks of pregnancy)
|
Changes in prenatal attachment levels measured using the Prenatal Attachment Inventory.
|
(between 24 and 41 weeks of pregnancy)
|
|
Maternal Attachment
Time Frame: 6th week after birth
|
Maternal attachment levels measured using the Maternal Attachment Scale during the early postpartum period.
|
6th week after birth
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- KAÜ-YMRKTNCİ
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.
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