- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06377891
The Effect of Emotional Resilience Training on Fear of Birth and Depression in Primiparous Pregnant Women
April 17, 2024 updated by: Elif Odabası Aktas, Ataturk University
The Effect of Emotional Resilience Training on Fear of Birth and Depression in Primiparous Pregnant Women: Randomized Controlled Study
Although birth has a great place in a woman's life, factors such as the woman's education level, personal experiences, social support status, whether the pregnancy is planned or not, the family's attitude towards pregnancy, and socioeconomic status increase the burden of pregnancy and can create a stressful situation for the woman.
While the pain that may be experienced during birth, thoughts about the baby's health and postpartum baby care further increase this fear, primiparous women who will give birth for the first time experience many emotions that they cannot define and cannot predict the situations they will encounter during birth.
The most important situation that will cause pain during birth is fear.
So much so that fear of birth may cause women to avoid pregnancy and increase optional abortions.In particular, fear of birth may increase cesarean delivery rates and also lead to negative maternal outcomes such as poor mental health after birth.
Fear experienced during the antenatal period can lead to difficult births, mother-baby attachment problems, and depression.
While fear of birth causes depression and anxiety disorders in the postpartum period, it is stated that depression experienced during pregnancy may increase the fear of birth, or fear of birth may be a hidden symptom of depression.
It is noted that emotional regulation skills and resilience in pregnant women can be effective strategies in minimizing and managing fear, anxiety, stress, and anxiety.
Emotional resilience is defined as the style of coping with stress, the ability to repair oneself, the ability to recover from adverse events quickly, and the state of adapting to a new environment.
In particular, individuals with high emotional resilience can protect their physical and mental health and increase their life satisfaction by reducing the negative consequences they experience.
With the emotional resilience training given during pregnancy, pregnant women's stress, fear, and anxiety will be reduced, and they will be able to cope better with the difficulties they experience.
This research will be conducted to examine the effect of emotional resilience training given to primiparous pregnant women on fear of childbirth and depression.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bayburt, Turkey, 69000
- Bayburt State Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Being over 18 years of age,
- Volunteering to participate in the research,
- 32-34. Being at the gestational age,
- Knowing Turkish,
- Being at least a primary school graduate,
- Having a single and healthy fetus,
- Having a WBDRS-A score of 38 and above,
- Being at least a primary school graduate.
- Depression score above 12/13,
Exclusion Criteria:
- Pregnant women with any risky pregnancy history (Preeclampsia, placenta previa, gestational diabetes mellitus, oligohydramnios and polyhydroamnios, etc.),
- Those who do not attend at least one of the sessions of the training program,
- Chronic and/or psychiatric health Pregnant women with problems (based on self-report and clinical diagnosis status) will be excluded from the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Emotional Resilience Group
Providing emotional resilience training to the experimental group.
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Primiparous pregnant women in the experimental group will be given emotional resilience training in the last trimester.
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No Intervention: Control group
There will be no intervention in the control group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The effect of emotional resilience on fear of birth and depression in primiparous pregnant women.
Time Frame: 32-34 gestational weeks - 4 follow-ups until the 6th week postpartum
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To make the effect of emotional resilience training given to primiparous pregnant women on fear of birth and depression during pregnancy and after birth visible with WIJMA-A and WIJMA-B fear of birth scale (Low (score ≤ 37), moderate (38-65), severe (66-84) and clinical fear of birth (≥ 85)) and Edinburgh depression scale (The cut-off point was calculated as 12/13, and women whose total scale score is more than the cut-off point are considered to be in the risk group)
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32-34 gestational weeks - 4 follow-ups until the 6th week postpartum
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 16, 2024
Primary Completion (Estimated)
October 30, 2024
Study Completion (Estimated)
December 30, 2024
Study Registration Dates
First Submitted
April 15, 2024
First Submitted That Met QC Criteria
April 17, 2024
First Posted (Actual)
April 22, 2024
Study Record Updates
Last Update Posted (Actual)
April 22, 2024
Last Update Submitted That Met QC Criteria
April 17, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TDK-2024-13563
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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