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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: the psychoeducation intervention program booklet
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.
Other: routine care
routine care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
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.
1 day (first meeting during pregnancy)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eskisehir Osmangazi University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 13, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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