Postpartum DepressionNCT06779903
Psychoeducatıon Interventıon Postpartum Depressıon Breastfeedıng
A study testing the psychoeducation intervention program booklet and routine care in people with Postpartum Depression and Psychoeducation, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to evaluate the effects of psychoeducation intervention for postpartum care on postpartum depression and breastfeeding. 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
- Postpartum Depression, Psychoeducation, Breastfeeding
- What is being tested?
- the psychoeducation intervention program booklet and routine care
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Nov 2024to 1 Mar 2025
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskisehir Osmangazi University
Eskişehir, Odunpazarı, 26000
About this study
Official title: 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.
Read the 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.
- Conditions
- Postpartum Depression, Psychoeducation, Breastfeeding, Postpartum Care
- Being tested
- the psychoeducation intervention program booklet, routine care
- Keywords
- Postpartum depression, Watson model, psychoeducation, breastfeeding
- Medical subject headings
- Depression, Postpartum, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the psychoeducation intervention program bookletOther
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).
routine careOther
routine care
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Active comparator | 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. Receives: Other: the psychoeducation intervention program booklet |
| control group | Placebo comparator | 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. Receives: Other: routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antenatal Breastfeeding Self-Efficacy Scale
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.
Measured: 1 day (first meeting during pregnancy)
Edinburgh Postpartum Depression Scale
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.
Measured: 1 day (first meeting during pregnancy and at the sixth week postpartum)
Postpartum Breastfeeding Self-Efficacy
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.
Measured: sixth week postpartum
Personal Information Form
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.
Measured: 1 day (first meeting during pregnancy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start13 Nov 2024
- Primary completion1 Jan 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum DepressionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Ozhuner, Eskisehir Osmangazi University
- Investigators
- Yasemin Özhüner, Principal investigator, Eskişehir Vadişehir Family center odunpazarı Turkeynebahat özerdoğan, Study director, Eskisehir Osmangazi University odunpazarı turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06779903
- Sponsor's protocol ID
- PSYCHOEDUCATION DEPRESSION
- Status last verified
- Mar 2025
- First submitted
- 11 Dec 2024
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozhuner Y, Ozerdogan N. The effect of psychoeducational intervention on postpartum care on postpartum depression and breastfeeding: a randomized controlled trial. BMC Nurs. 2025 Nov 26;24(1):1449. doi: 10.1186/s12912-025-04079-5.
PubMed 41299439
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Psychoeducatıon Interventıon For Postpartum Care On Postpartum Depressıon And Breastfeedıng
- ClinicalTrials.gov ID
- NCT06779903
- Acronym / sponsor ID
- PSYCHOEDUCATION DEPRESSION
- Conditions
- Postpartum Depression, Psychoeducation, Breastfeeding, Postpartum Care
- Keywords
- Postpartum depression, Watson model, psychoeducation, breastfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 17 Jan 2025 (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 study was planned to evaluate the effects of psychoeducation intervention for postpartum care on postpartum depression and breastfeeding.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model 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.
| Arm | Type | Receives |
|---|---|---|
| intervention group | Active comparator | Other: the psychoeducation intervention program bookletThe 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. |
| control group | Placebo comparator | Other: routine careThe 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 20-34. Women who are at the gestational age,
- over 18 years of age,
- planning to breastfeed,
- have no visual,
- hearing or mental disabilities,
Key exclusion criteria (7 listed)
- 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,
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 |
|---|---|---|
| the psychoeducation intervention program bookletPsychoeducation 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). | Other | intervention group |
| routine careroutine care | Other | control group |
Primary outcome
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.
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.
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.
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.
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 11 Mar 2025.
- Derived from this study: PubMed 41299439Ozhuner Y, Ozerdogan N. The effect of psychoeducational intervention on postpartum care on postpartum depression and breastfeeding: a randomized controlled trial. BMC Nurs. 2025 Nov 26;24(1):1449. doi: 10.1186/s12912-025-04079-5.
- Individual participant dataSharing planned: No
Related trials for Postpartum Depression
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Restoring Emotional Needs With Exogenous Ketones for Women With Postpartum Depression
Postpartum Depression (PPD)
Recruiting
Treatment With Repetitive Transcranial Magnetic Stimulation in Peripartal Depression
Depression During Pregnancy, Postpartum Depression (PPD)
Enrolling by invitation
Intervention to Reduce HIV Related Stigma Among Pregnant and Postpartum Women
HIV, HIV - Human Immunodeficiency Virus
RecruitingEarly Phase 1
A Web-based Intervention Program for Postpartum Depression
Postpartum Depression (PPD), Web-based Intervention
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.
Yasemin Özhüner principal investigator
Eskişehir Vadişehir Family center odunpazarı Turkey
nebahat özerdoğan study director
Eskisehir Osmangazi University odunpazarı turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the psychoeducation intervention program booklet and routine care in people with Postpartum Depression and Psychoeducation, run by Eskisehir Osmangazi University 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 6 inclusion and 7 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 11 Mar 2025. 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. Some participants in this study may receive a placebo. 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?
Antenatal Breastfeeding Self-Efficacy Scale (time frame: 1 day (first meeting during pregnancy)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06779903, which also lists 1 linked publication.
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 11 Mar 2025.