NCT06824480

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Study Start

First participant enrolled

February 1, 2024

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 7, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 13, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2025

Completed
Last Updated

May 8, 2025

Status Verified

February 1, 2025

Enrollment Period

1 year

First QC Date

February 7, 2025

Last Update Submit

May 5, 2025

Conditions

Keywords

debriefing, trauma, fear, depression

Outcome Measures

Primary Outcomes (6)

  • Personal Information Form

    It includes women's sociodemographic characteristics, education and employment status, and contact information.

    the first 12-24 hours after birth

  • Birth Process Evaluation Form

    It consists of 22 questions that include obstetric characteristics related to labor (gestational week, pregnancy planning/desire) and interventions performed during birth.

    the first 12-24 hours after birth

  • Wijma Birth Expectation/Experience Scale B version (W-DBÖ-B) at Birth:

    Wijma Birth Expectation/Experience Scale (W-DEQ) was developed by Klaas and Barbro Wijma (1998) to measure the fear of birth experienced by women. The scale consists of 32 items. The answers on the scale are numbered from 0 to 5 and are in the six-point Likert type. 0 is expressed as "completely" and 5 is expressed as "not at all". The minimum score on the scale is 0, while the maximum score is 160. As the score increases, the fear of childbirth experienced by women increases. Questions numbered 2, 3, 6, 7, 10, 11, 14, 18, 19, 23, 24, 26, 30 are calculated by reversing the scale. The scale, which was adapted to Turkish by Körükcü, Bulut and Kukulu and its validity and reliability were made, has six sub-dimensions. These dimensions are determined as Anxiety about contractions (items 1,2,6,11,15,16,18,23), inadequacy in positive behaviors (items 24,25,26,30), loneliness (items 3,7,10,14,19,21,22

    the first 12-24 hours after birth

  • Wijma Birth Expectation/Experience Scale B version (W-DBÖ-B) at Birth: (ANNEX-3)

    Wijma Birth Expectation/Experience Scale (W-DEQ) was developed by Klaas and Barbro Wijma (1998) to measure the fear of birth experienced by women. The scale consists of 32 items. The answers on the scale are numbered from 0 to 5 and are in the six-point Likert type. 0 is expressed as "completely" and 5 is expressed as "not at all". The minimum score on the scale is 0, while the maximum score is 160. As the score increases, the fear of childbirth experienced by women increases. Questions numbered 2, 3, 6, 7, 10, 11, 14, 18, 19, 23, 24, 26, 30 are calculated by reversing the scale. The scale, which was adapted to Turkish by Körükcü, Bulut and Kukulu and its validity and reliability were made, has six sub-dimensions. These dimensions are determined as Anxiety about contractions (items 1,2,6,11,15,16,18,23), inadequacy in positive behaviors (items 24,25,26,30), loneliness (items 3,7,10,14,19,21,22

    first 6-8 weeks after birth

  • City Birth Trauma Scale (CityBiTS)

    The City Birth Trauma Scale (CityBiTS) was developed by Susan Ayers and colleagues to assess PTSD and its symptoms in the postpartum period. The original measurement tool had a Cronbach's Alpha coefficient of 0.92 for the entire scale and between 0.82 and 0.88 for the subscales The scale consists of 29 items and is a four-point Likert-type scale. The scale assesses symptoms of stress (items 1-2), re-experiencing (items 3-7), avoidance (items 8-9), negative cognitions and mood (items 10-16), and hyperarousal (items 17-22). In addition, items 23 and 24 of the scale focus on dissociative symptoms, with a score of "0" in item 25 indicating pre-partum onset of PTSD and a score of "2" indicating delayed onset PTSD. The duration of symptoms is assessed with item 26. While distress and impairment symptoms are assessed with items 27 and 28, the last item of the scale (item 29) is the exclusion criterion for PTSD . Items 3-22 can be scored on the scale and a score between 0-60 can be.

    first 6-8 weeks after birth

  • Edinburgh Postpartum Depression Scale (EDPS)

    EPDS was developed by Cox and colleagues in 1987 and is a measurement tool that determines the risk, level, and severity of depression in the postpartum period. The scale is a self-assessment scale. The measurement tool consists of 10 items on a four-point Likert-type scale evaluated between 0 and 3. The highest score that can be obtained from the scale is 30. Questions 1, 2, and 4 on the scale are scored in the format 0-1-2-3, while questions 3, 5, 6, 7, 8, 9, and 10 are scored in the format 3-2-1-0. The cut-off point of the scale was calculated as 13. Cronbach's alpha value of the original version of EPDS was determined as 0.87. The Turkish validity and reliability study of the scale was conducted by Aydın and his colleagues in 2004, and Cronbach's alpha value was determined as 0.72.

    first 6-8 weeks after birth

Study Arms (2)

experimental: debriefing grup

EXPERIMENTAL

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.

Behavioral: debriefing group

experimental: control grup

EXPERIMENTAL

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.

Behavioral: control group

Interventions

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: debriefing grup
control groupBEHAVIORAL

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.

experimental: control grup

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mersin university

Mersin, Turkey (Türkiye)

RECRUITING

Mersin University

Mersin, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Psychological Well-BeingWounds and InjuriesDepression

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorBehavioral Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

gozde gokce ısbir professor dr. Gozde GOKCE ISBIR

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PROFESSOR

Study Record Dates

First Submitted

February 7, 2025

First Posted

February 13, 2025

Study Start

February 1, 2024

Primary Completion

February 7, 2025

Study Completion

June 15, 2025

Last Updated

May 8, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations