NCT07506759

Brief Summary

This research was conducted to examine the effect of psychodramatic role-playing in childbirth preparation courses on postpartum depression, self-efficacy, and perception of social support. The study was conducted using a randomized controlled experimental design between October 31, 2025, and February 25, 2026. The study population consisted of pregnant women who applied to the Antenatal School of Zeynep Kamil Women and Children's Diseases Training and Research Hospital. The sample size was calculated as 57 pregnant women (control: 29, intervention: 28). While the control group received standard childbirth preparation education, the intervention group received standard childbirth preparation education as well as psychodramatic role-playing. The Demographic Information Form, General Self-Efficacy Scale, Multidimensional Perceived Social Support Scale, and Edinburgh Postnatal Depression Scale were used to collect research data. The study findings revealed no significant differences between the control and intervention groups in terms of sociodemographic and obstetric characteristics. Furthermore, no significant differences were found between the control and intervention groups in pre-test and post-test scores on the General Self-Efficacy Scale, Multidimensional Perceived Social Support Scale, and Edinburgh Postnatal Depression Scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 31, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 23, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 2, 2026

Completed
Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

February 23, 2026

Last Update Submit

March 28, 2026

Conditions

Keywords

Childbirth Preparation EducationPsychodramatic Role-PlayingPerceived Social SupportPregnant WomenMaternal Self-EfficacyRandomized Controlled TrialPostpartum Depression

Outcome Measures

Primary Outcomes (1)

  • Postpartum Depression

    Edinburgh Postpartum Depression Scale will be applied to examine the effect of home visits and prenatal education on postpartum depression. Edinburgh Postpartum Depression Scale (EPDS); EPDS is a 4-point Likert style self-report scale consisting of 10 items. PRES was adapted to Turkish by Engindeniz. In Engindeniz's validity and reliability study, this scale had an internal consistency coefficient of 0.79, a split-half reliability, a cut-off of 0.80 of 12/13, a sensitivity of 0.84, a specificity of 0.88, a positive predictive value of 0.69, and a negative predictive value of 0.94. The Edinburgh Postnatal Depression Scale is a 10-item self-report scale assessing the common symptoms of depression. Each item is scored on a 4 point scale (O-3), the minimum and maximum total score ranging from O-30, respec- tively. The highest score is 30 points. If it is less than 9 points, there is no risk for depression, if it is 13 and above, there is a high risk for depression.

    Postpartum week 1 and postpartum week 8

Secondary Outcomes (2)

  • Maternal Self-Efficacy

    Postpartum week 1 and postpartum week 8

  • Perceived Social Support

    Postpartum week 1 and postpartum week 8

Study Arms (2)

Psychodramatic Role-Playing Childbirth Education

EXPERIMENTAL

Participants in the intervention group received childbirth preparation education integrated with psychodramatic role-playing techniques. The sessions included interactive role-playing activities aimed at enhancing emotional expression, coping skills, self-efficacy, and perceived social support during pregnancy and the postpartum period.

Behavioral: Psychodramatic Role-Playing Childbirth Education

Standard Childbirth Education

ACTIVE COMPARATOR

Participants in the control group received the standard childbirth preparation education program routinely provided in the childbirth education classes without psychodramatic role-playing components.

Behavioral: Standard Childbirth Education

Interventions

Psychodramatic role-playing integrated into childbirth preparation education was administered to the intervention group. The program included structured educational sessions combined with interactive role-playing activities aimed at improving emotional expression, coping skills, maternal self-efficacy, and perceived social support during pregnancy and the postpartum period.

Psychodramatic Role-Playing Childbirth Education

The control group received the standard childbirth preparation education routinely provided in childbirth education classes without psychodramatic role-playing components.

Standard Childbirth Education

Eligibility Criteria

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

You may qualify if:

  • Agree to participate in the study and be able to speak and understand Turkish,
  • Be 18 years of age or older,
  • Be at least literate,
  • Be a primiparous pregnant woman,
  • Be at least 32 weeks and no more than 36 weeks pregnant,
  • Have no psychological disorders or chronic illnesses.

You may not qualify if:

  • Being multiparous,
  • Being less than 32 weeks pregnant,
  • Being in the high-risk pregnancy category,
  • Having received childbirth preparation training from another institution or individual,
  • Not having completed the training program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zeynep Kamil Women and Children's Diseases Training and Research Hospital

Istanbul, 34668, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This study was conducted as an open-label trial due to the nature of the educational intervention, and blinding of participants and investigators was not feasible.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to intervention and control groups. The intervention group received childbirth preparation education integrated with psychodramatic role-playing, while the control group received standard childbirth preparation education.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 23, 2026

First Posted

April 2, 2026

Study Start

October 31, 2025

Primary Completion

January 15, 2026

Study Completion

January 15, 2026

Last Updated

April 2, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations