- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06779903
Psychoeducatıon Interventıon Postpartum Depressıon Breastfeedıng
March 7, 2025 updated by: Yasemin Ozhuner, Eskisehir Osmangazi University
Effect Of Psychoeducatıon Interventıon For Postpartum Care On Postpartum Depressıon And Breastfeedıng
This study was planned to evaluate the effects of psychoeducation intervention for postpartum care on postpartum depression and breastfeeding.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
The pregnant women included in the sample were informed about the study and their written informed consent was obtained.
Six interviews were conducted with the pregnant women, four at one-week intervals before birth, and one on the tenth day and sixth week after birth.
These interviews were conducted with the women one-on-one and face-to-face.Women in the control group were not given any treatment other than routine care at family health centers.
The psychoeducation program was applied to the women in the intervention group in six interviews.
Study Type
Interventional
Enrollment (Actual)
102
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Odunpazarı
-
Eskişehir, Odunpazarı, Turkey, 26000
- Eskisehir Osmangazi University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 20-34. Women who are at the gestational age,
- over 18 years of age,
- planning to breastfeed,
- have no visual,
- hearing or mental disabilities,
- have a healthy fetus on ultrasonography
Exclusion Criteria:
- Women with depression and other mental illnesses diagnosed by a physician,
- those taking medication related to their mental illness,
- those who gave birth prematurely,
- those with contraindications to breastfeeding and newborns (head and spine anomalies such as anencephaly/spina bifida, having a fetus with brain anomalies such as hydrocephalus/microcephaly, active substance use or HIV diagnosis, etc.),
- those who were included in the study in the 3rd trimester but whose birth weight was less than 2500 grams,
- those whose babies were taken to the neonatal intensive care unit due to any postpartum complications and those who had premature babies (born before 37 weeks of gestation),
- those who did not participate in more than one interview
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: intervention group
The pregnant women included in the sample were informed about the study and their written informed consent was obtained.
Six interviews were conducted with the pregnant women, four at one-week intervals before birth, and one on the tenth day and sixth week after birth.
These interviews were conducted with the women one-on-one and face-to-face.
psychoeducation program was applied to the women in the intervention group in six interviews.In the first interview, the psychoeducation intervention program booklet based on the Watson Model for postpartum care was given to the women and the interview was conducted within the scope of the program.
The psychoeducation intervention program sessions based on the Watson Model for postpartum care in the study were conducted according to the WİBM improvement processes and psychoeducation techniques.
The interviews lasted between 90 and 120 minutes on average.
|
Psychoeducation Program was composed of nine basic topics (postpartum period and care, adaptation to the role of motherhood and mother-infant bonding, postpartum psychological changes, frequency, causes, symptoms of PPD, effects on mother, child and community health, diagnosis and treatment, preventive practices, social support and suggestions for coping, breast milk and breastfeeding, breast care and practices, nutrition and baby care).
|
|
Placebo Comparator: control group
The pregnant women included in the sample were informed about the study and their written informed consent was obtained.
Six interviews were conducted with the pregnant women, four at one-week intervals before birth, and one on the tenth day and sixth week after birth.
These interviews were conducted with the women one-on-one and face-to-face.Women in the control group were not given any treatment other than routine care at family health centers.
In routine care, pregnant women were subjected to edema, varicose veins, weight, blood pressure, pulse, laboratory findings, baby heart sounds, medication intake, chronic disease follow-up and vaccination.
Pregnant women were provided with counseling if they had any questions.
Postpartum women were subjected to blood pressure, fever, pulse, bleeding and laboratory findings follow-up and were provided with counseling if they had any questions.
|
routine care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Antenatal Breastfeeding Self-Efficacy Scale
Time Frame: 1 day (first meeting during pregnancy)
|
The scale consists of a total of 20 items.
The scale is a 5-point Likert type.
The lowest score that can be obtained from the scale is 20 and the highest score is 100.
An increase in the score obtained from the scale indicates that the perception of breastfeeding self-efficacy has increased.
|
1 day (first meeting during pregnancy)
|
|
Edinburgh Postpartum Depression Scale
Time Frame: 1 day (first meeting during pregnancy and at the sixth week postpartum)
|
It is a 10-item self-report scale that measures maternal depressive symptoms over the past seven days.
Higher scores reflect more depressive symptoms.
Symptoms are rated on a 4-point Likert scale with scores ranging from 0 to 30.
The cut-off score of the scale was determined as ≥13.
If the total score of the scale is 12 or less, the participant is not at risk for PPD, but if he scores 13 or more, he is at risk.
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1 day (first meeting during pregnancy and at the sixth week postpartum)
|
|
Postpartum Breastfeeding Self-Efficacy
Time Frame: sixth week postpartum
|
Breastfeeding Self-efficacy Short Form is a 5-point Likert-type scale.
The lowest score that can be obtained from the scale is 14 and the highest score is 70.
A higher score indicates higher breastfeeding self-efficacy.
|
sixth week postpartum
|
|
Personal Information Form
Time Frame: 1 day (first meeting during pregnancy)
|
The form created to determine the socio-demographic characteristics of the individuals included in the research was prepared by the researcher in line with the literature.
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1 day (first meeting during pregnancy)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yasemin Özhüner, Eskişehir Vadişehir Family center odunpazarı Turkey
- Study Director: Nebahat Ozerdogan, Eskisehir Osmangazi University odunpazarı turkey
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 13, 2024
Primary Completion (Actual)
January 1, 2025
Study Completion (Actual)
March 1, 2025
Study Registration Dates
First Submitted
December 11, 2024
First Submitted That Met QC Criteria
January 15, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 7, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PSYCHOEDUCATION DEPRESSION
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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