Postpartum DepressionNCT07506759
The Effect of Psychodramatic Role-Playing on Postpartum Depression, Self-Efficacy, and Perceived Social Support
A study testing Psychodramatic Role-Playing Childbirth Education and Standard Childbirth Education in people with Postpartum Depression and Maternal Self-Efficacy, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Depression, Maternal Self-Efficacy, Perceived Social Support
- What is being tested?
- Psychodramatic Role-Playing Childbirth Education and Standard Childbirth Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Oct 2025to 15 Jan 2026
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zeynep Kamil Women and Children's Diseases Training and Research Hospital
Istanbul, 34668
About this study
Official title: The Effect of Psychodramatic Role-Playing Used in Childbirth Preparation Classes on Postpartum Depression, Self-Efficacy, and Perceived Social Support
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.
Read the detailed description
Childbirth preparation education plays a crucial role in reducing anxiety, increasing maternal self-efficacy, and enhancing perceived social support during pregnancy and the postpartum period. Innovative educational approaches, such as psychodramatic role-playing, may strengthen coping skills and emotional preparedness for childbirth. This randomized controlled trial was conducted to evaluate the effectiveness of psychodramatic role-playing integrated into childbirth preparation classes provided in a maternity education program.
The study included pregnant women between 32 and 36 weeks of gestation who voluntarily participated in the childbirth education program. Participants were randomly allocated into intervention and control groups. The intervention group received structured childbirth preparation education sessions enriched with psychodramatic role-playing techniques designed to improve emotional expression, coping strategies, and social interaction. The control group received the standard childbirth preparation education program.
Data were collected at baseline and during the postpartum period using standardized measurement tools including the Edinburgh Postnatal Depression Scale (EPDS), the Multidimensional Scale of Perceived Social Support (MSPSS), and the General Self-Efficacy Scale. The primary outcomes of the study were postpartum depression, maternal self-efficacy, and perceived social support. This study aims to provide evidence on the effectiveness of psychosocial and interactive educational interventions in childbirth education programs and to support the development of evidence-based maternal care practices.
- Being tested
- Psychodramatic Role-Playing Childbirth Education, Standard Childbirth Education
- Keywords
- Childbirth Preparation Education, Psychodramatic Role-Playing, Perceived Social Support, Pregnant Women, Maternal Self-Efficacy, Randomized Controlled Trial, Postpartum Depression
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychodramatic Role-Playing Childbirth EducationBehavioural
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.
Standard Childbirth EducationBehavioural
The control group received the standard childbirth preparation education routinely provided in childbirth education classes without psychodramatic role-playing components.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard Childbirth Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postpartum week 1 and postpartum week 8
Secondary outcomes (2)
Maternal Self-Efficacy
Maternal self-efficacy levels measured using the General Self-Efficacy Scale. The General Self-Efficacy Scale was developed by Ralf Schwarzer and Matthias Jerusalem to assess individuals' general perceptions of self-efficacy in coping with stressful situations and managing challenging life events. The scale is a self-report measure consisting of 10 items on a 4-point Likert scale (1 = not at all true, 4 = completely true). The total score obtainable from the scale ranges from 10 to 40, with higher scores indicating a higher level of self-efficacy.
Measured: Postpartum week 1 and postpartum week 8
Perceived Social Support
Perceived social support levels assessed using the Multidimensional Scale of Perceived Social Support. The Multidimensional Scale of Perceived Social Support was developed by Gregory D. Zimet and colleagues to assess the level of social support individuals perceive from their family, friends and a specific person. The scale consists of a total of 12 items and uses a 7-point Likert scale (1 = strongly disagree, 7 = strongly agree).
The scale comprises three sub-dimensions: family support, friend support and support from a significant other. Each sub-dimension consists of 4 items. The total score obtained from the scale ranges from 12 to 84, with higher scores indicating a higher level of perceived social support.
Measured: Postpartum week 1 and postpartum week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start31 Oct 2025
- Primary completion15 Jan 2026
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- 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.
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Uskudar University
- Responsible party
- Principal investigator, Ayça Demir Yıldırım, PhD, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07506759
- Sponsor's protocol ID
- Ü. Ü. Ebe Feyza KALE
- Status last verified
- Mar 2026
- First submitted
- 23 Feb 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Psychodramatic Role-Playing Used in Childbirth Preparation Classes on Postpartum Depression, Self-Efficacy, and Perceived Social Support
- ClinicalTrials.gov ID
- NCT07506759
- Acronym / sponsor ID
- Ü. Ü. Ebe Feyza KALE
- Keywords
- Childbirth Preparation Education, Psychodramatic Role-Playing, Perceived Social Support, Pregnant Women, Maternal Self-Efficacy, Randomized Controlled Trial, Postpartum Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Uskudar University
- Study start
- 31 Oct 2025 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 2 Apr 2026 (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 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.
Detailed description
Childbirth preparation education plays a crucial role in reducing anxiety, increasing maternal self-efficacy, and enhancing perceived social support during pregnancy and the postpartum period. Innovative educational approaches, such as psychodramatic role-playing, may strengthen coping skills and emotional preparedness for childbirth. This randomized controlled trial was conducted to evaluate the effectiveness of psychodramatic role-playing integrated into childbirth preparation classes provided in a maternity education program.
The study included pregnant women between 32 and 36 weeks of gestation who voluntarily participated in the childbirth education program. Participants were randomly allocated into intervention and control groups. The intervention group received structured childbirth preparation education sessions enriched with psychodramatic role-playing techniques designed to improve emotional expression, coping strategies, and social interaction. The control group received the standard childbirth preparation education program.
Data were collected at baseline and during the postpartum period using standardized measurement tools including the Edinburgh Postnatal Depression Scale (EPDS), the Multidimensional Scale of Perceived Social Support (MSPSS), and the General Self-Efficacy Scale. The primary outcomes of the study were postpartum depression, maternal self-efficacy, and perceived social support. This study aims to provide evidence on the effectiveness of psychosocial and interactive educational interventions in childbirth education programs and to support the development of evidence-based maternal care practices.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Psychodramatic Role-Playing Childbirth Education | Experimental | Behavioral: Psychodramatic Role-Playing Childbirth EducationParticipants 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. |
| Standard Childbirth Education | Active comparator | Behavioral: Standard Childbirth EducationParticipants in the control group received the standard childbirth preparation education program routinely provided in the childbirth education classes without psychodramatic role-playing components. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Agree to participate in the study and be able to speak and understand Turkish,
Key exclusion criteria (5 listed)
- Being multiparous,
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 |
|---|---|---|
| Psychodramatic Role-Playing Childbirth EducationPsychodramatic 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. | Behavioural | Psychodramatic Role-Playing Childbirth Education |
| Standard Childbirth EducationThe control group received the standard childbirth preparation education routinely provided in childbirth education classes without psychodramatic role-playing components. | Behavioural | Standard Childbirth Education |
Primary outcome
Postpartum Depression
Time frame: Postpartum week 1 and postpartum week 8
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.
2 secondary outcomes
Maternal Self-Efficacy
Time frame: Postpartum week 1 and postpartum week 8
Perceived Social Support
Time frame: Postpartum week 1 and postpartum week 8
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 2 Apr 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychodramatic Role-Playing Childbirth Education and Standard Childbirth Education in people with Postpartum Depression and Maternal Self-Efficacy, run by Istanbul University - Cerrahpasa 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 5 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 2 Apr 2026. 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. 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?
Postpartum Depression (time frame: Postpartum week 1 and postpartum week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2026.