The Effect of Postpartum Debriefing on the Psychological Outcomes

NCT ID: NCT06824480

Last Updated: 2025-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2025-06-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study was planned to determine the effect of re-signification of birth in the early postpartum period on postpartum fear of childbirth, postpartum depression and birth trauma.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study was contucted between february 2024 and June 2025 in Turkey , as a single-blind randomized controlled experimental study to determine the effect of reinterpretation of birth on postpartum fear of childbirth, postpartum depression and birth trauma.During data collection, participants were informed about the purpose of the study and those who volunteered to participate in the research were accepted into the study by signing an informed consent form.Data; When the study was approved, it was planned to be collected face to face within the first 12-24 hours after birth and by telephone within 6-8 weeks after birth. CONSORT directive was followed in the research planning.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Well-Being, Psychological

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

experimental: debriefing grup

Women who volunteered to participate in the study and met the participation criteria were informed about the study. The first session will be held face to face in the clinic for 40 minutes. Then, the second session will be held by phone within 4-6 weeks after birth, with a total of 2 meetings with each woman for approximately 40 minutes.

Group Type EXPERIMENTAL

debriefing group

Intervention Type BEHAVIORAL

Women who volunteered to participate in the study and met the participation criteria were informed about the study. The first session will be held face to face in the clinic for 40 minutes. Then, the second session will be held by phone within 4-6 weeks after birth, with a total of 2 meetings with each woman for approximately 40 minutes.

experimental: control grup

The women in the control group will be asked how the birth went within 12-24 hours after birth by the researcher as part of their routine care, but no detailed analysis or interpretation will be made.

Group Type EXPERIMENTAL

control group

Intervention Type BEHAVIORAL

he women in the control group will be asked how the birth went within 12-24 hours after birth by the researcher as part of their routine care, but no detailed analysis or interpretation will be made.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

debriefing group

Women who volunteered to participate in the study and met the participation criteria were informed about the study. The first session will be held face to face in the clinic for 40 minutes. Then, the second session will be held by phone within 4-6 weeks after birth, with a total of 2 meetings with each woman for approximately 40 minutes.

Intervention Type BEHAVIORAL

control group

he women in the control group will be asked how the birth went within 12-24 hours after birth by the researcher as part of their routine care, but no detailed analysis or interpretation will be made.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Women who volunteer to participate in the study, Whose mother tongue is Turkish, Who are between the ages of 18-45, Who are at least primary school graduates, Who are 37-42 weeks pregnant, Who are nulliparous, Who have a healthy pregnancy, Who do not have a psychological condition or psychiatric disorder, Who are monitored and cared for in the first 24 hours after birth at the Tarsus State Hospital Maternity Department, Who approve of the reinterpretation of birth application to be carried out by the researcher will be included in the sample.

Exclusion Criteria

Those who did not volunteer to participate in the study, Those who gave birth before the 37th week of pregnancy, Those who were multiparous, Those who had abnormal medical conditions during pregnancy (placental disorder, preeclampsia, premature birth threat, etc.),

Those whose native language is not Turkish, Those who have visual, speech and hearing impairments, Those who had an emergency cesarean section, Those who stayed in the hospital for less than 12 hours after birth, Those who received a psychiatric diagnosis during the postpartum period (except those diagnosed with postpartum depression and post-traumatic stress disorder related to birth), Those who could not be reached by phone during the follow-up of the study, Women who developed complications in the first 24 hours after birth and required intensive care, Those whose babies required neonatal intensive care during the postpartum period, Those who experienced another life event that traumatized the woman during the postpartum period (harassment, rape, earthquake, accident, loss of a loved one) etc.) Those who want to withdraw from the study at any stage of the study will not be included in the sample.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mersin University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gozde Gokce Isbir

PROFESSOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mersin university

Mersin, , Turkey (Türkiye)

Site Status RECRUITING

Mersin University

Mersin, , Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

gozde gokce ısbir professor dr. Gozde GOKCE ISBIR

Role: CONTACT

+905057782319

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mersin University Mersin University

Role: primary

+903243610001

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

VBalci

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Effect of Podcast Training on Birth Fear in Couples
NCT06929975 ENROLLING_BY_INVITATION NA