- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06824480
The Effect of Postpartum Debriefing on the Psychological Outcomes
The Effect of Debriefing of Childbirth in the Early Postpartum Period on the Psychological Outcomes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: gozde gokce ısbir professor dr. Gozde GOKCE ISBIR
- Phone Number: +905057782319
- Email: gozdegokce@gmail.com
Study Locations
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Mersin, Turkey
- Recruiting
- Mersin University
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Contact:
- Mersin University Mersin University
- Phone Number: +903243610001
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 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.
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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.
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Experimental: 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Personal Information Form
Time Frame: the first 12-24 hours after birth
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It includes women's sociodemographic characteristics, education and employment status, and contact information.
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the first 12-24 hours after birth
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Birth Process Evaluation Form
Time Frame: the first 12-24 hours after birth
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It consists of 22 questions that include obstetric characteristics related to labor (gestational week, pregnancy planning/desire) and interventions performed during birth.
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the first 12-24 hours after birth
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Wijma Birth Expectation/Experience Scale B version (W-DBÖ-B) at Birth:
Time Frame: the first 12-24 hours after birth
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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
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the first 12-24 hours after birth
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Wijma Birth Expectation/Experience Scale B version (W-DBÖ-B) at Birth: (ANNEX-3)
Time Frame: first 6-8 weeks after birth
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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
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first 6-8 weeks after birth
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City Birth Trauma Scale (CityBiTS)
Time Frame: first 6-8 weeks after birth
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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.
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first 6-8 weeks after birth
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Edinburgh Postpartum Depression Scale (EDPS)
Time Frame: first 6-8 weeks after birth
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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.
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first 6-8 weeks after birth
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- VBalci
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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