NCT07062159

Brief Summary

The study aims to evaluate the effectiveness of a psychoeducational intervention designed within the framework of the Watson Human Caring Model in reducing postpartum depressive symptoms and creating a stronger mother-infant bond. Specifically, it aims to investigate whether a person-centered approach based on the principles of Watson's caring science can significantly increase the psychological well-being of postpartum mothers and improve the quality of their relationship with their babies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2025

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

First Submitted

Initial submission to the registry

July 2, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

July 2, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 14, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2026

Completed
Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

July 2, 2025

Last Update Submit

January 5, 2026

Conditions

Keywords

Postpartum DepressionWatson modelpsychoeducationMother-Infant Interaction

Outcome Measures

Primary Outcomes (3)

  • Prenatal Attachment Scale

    Prenatal Attachment Scale The scale consists of 21 items in total. The highest score on the scale is 84, the lowest score is 21, and the increase in the total score obtained from the scale indicates that prenatal attachment is positive.

    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 fourth week postpartum)

  • Mother-Infant Attachment Scale

    Mother-Infant Attachment Scale This scale, which is used from the first day after birth, allows the mother to describe her feelings towards her baby in one word. The lowest score that can be obtained from the scale is 0 and the highest score is 24. As the score increases, attachment is negatively affected.

    fourth week postpartum

Study Arms (2)

intervention group

ACTIVE COMPARATOR

Active Comparator: intervention group The pregnant women in the sample were informed about the study and their written consent was obtained. A total of six interviews were conducted with the pregnant women, four at one-week intervals before birth and one interview on the seventh day and fourth week after birth. These interviews were conducted with the women one-on-one and face-to-face. The psychoeducation program was applied to the women in the intervention group in six interviews. In the first interview, the women were given a booklet of the psychoeducation intervention program based on the Watson Human Caring Model for postpartum care and the interview was conducted within the scope of the program. The psychoeducation intervention program interviews based on the Watson Human Caring Model in the study were conducted according to the Watson Human Caring Model improvement processes and psychoeducation techniques. The interviews lasted between 60-90 minutes on average.

Other: the psychoeducation intervention program

control group

PLACEBO COMPARATOR

Placebo Comparator: Control Group The pregnant women in the sample were informed about the study and their written consent was obtained. Six interviews were conducted with the pregnant women, four at one-week intervals before delivery and once on the seventh day and fourth week after delivery. These interviews were conducted with the women one-on-one and face-to-face. The women in the control group did not receive any treatment other than their routine care at family health centers. In routine care, pregnant women were examined for 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. After delivery, women were provided with medication intake, blood pressure, fever, pulse, bleeding and laboratory findings and counseling if they had any questions.

Other: routine care

Interventions

routine care

control group

The content of the psychoeducation intervention program based on the Watson Human Caring Model will consist of the postpartum process and care, maternal blues, postpartum psychosis, postpartum depression, frequency, causes, predisposing factors, symptoms, effects on mother, child and community health, diagnosis and treatment, preventive practices, social support, adaptation to the role of motherhood, mother and baby bonding, practices that will strengthen mother-baby bonding, breast milk and breastfeeding, nutrition and baby care, problems encountered in baby care and solution suggestions.

intervention group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women in their 20-35th week of pregnancy,
  • Volunteers,
  • Over 18 years of age,
  • Literate,
  • No visual, hearing or mental disabilities,
  • Having a healthy baby weighing over 2500 grams,
  • Being in the same environment with their baby after birth,
  • Having a healthy fetus on ultrasound will be included in the study.

You may not qualify if:

  • Those diagnosed with depression or other mental illnesses by a physician,
  • Those taking medication for mental illness,
  • Women who have given birth prematurely,
  • Stillbirth,
  • Those who have not participated in more than one interview will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskisehir Osmangazi University

Eskişehir, Odunpazarı, 26000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Study Officials

  • Yasemin Özhüner

    Eskişehir Vadişehir Family center odunpazarı Turkey

    PRINCIPAL INVESTIGATOR
  • Nebahat Ozerdogan

    Eskisehir Osmangazi University odunpazarı turkey

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
control group (44) intervention group (44)
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The pregnant women included in the sample were informed about the study and their written consent was obtained. Six interviews were conducted with the pregnant women, four at one-week intervals before birth and one on the seventh day and fourth week after birth. These interviews were conducted with the women one-on-one and face-to-face. The women in the control group did not receive any treatment other than routine care at family health centers. The psychoeducation program was administered to the women in the intervention group in six interviews.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
DR

Study Record Dates

First Submitted

July 2, 2025

First Posted

July 14, 2025

Study Start

July 2, 2025

Primary Completion

August 19, 2025

Study Completion

January 5, 2026

Last Updated

January 7, 2026

Record last verified: 2026-01

Locations