Well-Being, PsychologicalNCT06824480
The Effect of Postpartum Debriefing on the Psychological Outcomes
A study testing debriefing group in people with Well-Being, Psychological, run by Mersin University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Well-Being, Psychological
- What is being tested?
- debriefing group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 15 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Mersin university
Mersin
- Recruiting
Mersin University
Mersin
Mersin University Mersin University, +903243610001
About this study
Official title: The Effect of Debriefing of Childbirth in the Early Postpartum Period on the Psychological Outcomes
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.
Read the detailed description
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
- Well-Being, Psychological
- Being tested
- debriefing group, control group
- Keywords
- debriefing, trauma, fear, depression
- Medical subject headings
- Psychological Well-Being, Wounds and Injuries, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
debriefing groupBehavioural
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.
control groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal Information Form
It includes women's sociodemographic characteristics, education and employment status, and contact information.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: first 6-8 weeks after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start1 Feb 2024
- Primary completion7 Feb 2025
- Study completion15 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Well-Being, PsychologicalStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gozde Gokce Isbir, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06824480
- Sponsor's protocol ID
- VBalci
- Status last verified
- Feb 2025
- First submitted
- 7 Feb 2025
- Last updated
- 8 May 2025
- 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 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Debriefing of Childbirth in the Early Postpartum Period on the Psychological Outcomes
- ClinicalTrials.gov ID
- NCT06824480
- Acronym / sponsor ID
- VBalci
- Conditions
- Well-Being, Psychological
- Keywords
- debriefing, trauma, fear, depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 7 Feb 2025 (actual)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 13 Feb 2025 (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 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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental: debriefing grup | Experimental | Behavioral: debriefing groupWomen 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 | Experimental | Behavioral: control groupThe 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| debriefing groupWomen 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. | Behavioural | experimental: debriefing grup |
| control grouphe 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. | Behavioural | experimental: control grup |
Primary outcome
Personal Information Form
Time frame: the first 12-24 hours after birth
It includes women's sociodemographic characteristics, education and employment status, and contact information.
Birth Process Evaluation Form
Time frame: the first 12-24 hours after birth
It consists of 22 questions that include obstetric characteristics related to labor (gestational week, pregnancy planning/desire) and interventions performed during birth.
Wijma Birth Expectation/Experience Scale B version (W-DBÖ-B) at Birth:
Time frame: the first 12-24 hours after 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
Wijma Birth Expectation/Experience Scale B version (W-DBÖ-B) at Birth: (ANNEX-3)
Time frame: first 6-8 weeks after 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
City Birth Trauma Scale (CityBiTS)
Time frame: first 6-8 weeks after birth
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.
Edinburgh Postpartum Depression Scale (EDPS)
Time frame: first 6-8 weeks after birth
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing debriefing group in people with Well-Being, Psychological, run by Mersin University at 2 sites 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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact gozde gokce ısbir professor dr. Gozde GOKCE ISBIR (+905057782319, gozdegokce@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personal Information Form (time frame: the first 12-24 hours after birth). The study lists 6 primary outcomes in all. 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 8 May 2025.