NCT06779903

Brief Summary

This study was planned to evaluate the effects of psychoeducation intervention for postpartum care on postpartum depression and breastfeeding.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 13, 2024

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

December 11, 2024

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 17, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

March 11, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

December 11, 2024

Last Update Submit

March 7, 2025

Conditions

Keywords

Postpartum depressionWatson modelpsychoeducationbreastfeeding

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    1 day (first meeting during pregnancy)

Study Arms (2)

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.

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.

Other: routine care

Interventions

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).

intervention group

routine care

control group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskisehir Osmangazi University

Eskişehir, Odunpazarı, 26000, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Depression, PostpartumBreast Feeding

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental DisordersFeeding BehaviorBehavior

Study Officials

  • Yasemin Özhüner

    Eskişehir Vadişehir Family center odunpazarı Turkey

    PRINCIPAL INVESTIGATOR
  • nebahat özerdoğan

    Eskisehir Osmangazi University odunpazarı turkey

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
control group (55) intervention group (55)
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 11, 2024

First Posted

January 17, 2025

Study Start

November 13, 2024

Primary Completion

January 1, 2025

Study Completion

March 1, 2025

Last Updated

March 11, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations