Fear of ChildbirthNCT06377891
The Effect of Emotional Resilience Training on Fear of Birth and Depression in Primiparous Pregnant Women
A study testing Emotional Resilience training in people with Fear of Childbirth and Depression, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fear of Childbirth, Depression
- What is being tested?
- Emotional Resilience training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Apr 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
Show all 9Show fewer
- Having a WBDRS-A score of 38 and above,
- Being at least a primary school graduate.
- Depression score above 12/13,
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Fear of Childbirth, Depression
- Being tested
- Emotional Resilience training
- Keywords
- Resilience, Pregnant, Primiparous, Fear of Childbirth, Depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional Resilience trainingOther
Primiparous pregnant women in the experimental group will be given emotional resilience training in the last trimester.
| Study group | Role | What they receive |
|---|---|---|
| Emotional Resilience Group | Experimental | Providing emotional resilience training to the experimental group. Receives: Other: Emotional Resilience training |
| Control group | No intervention | There will be no intervention in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of emotional resilience on fear of birth and depression in primiparous pregnant women.
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)
Measured: 32-34 gestational weeks - 4 follow-ups until the 6th week postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start16 Apr 2024 (estimated)
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fear of ChildbirthStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Odabası Aktas, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06377891
- Sponsor's protocol ID
- TDK-2024-13563
- Status last verified
- Apr 2024
- First submitted
- 15 Apr 2024
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Emotional Resilience Training on Fear of Birth and Depression in Primiparous Pregnant Women: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06377891
- Acronym / sponsor ID
- TDK-2024-13563
- Conditions
- Fear of Childbirth, Depression
- Keywords
- Resilience, Pregnant, Primiparous, Fear of Childbirth, Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 16 Apr 2024 (estimated)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 22 Apr 2024 (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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emotional Resilience Group | Experimental | Other: Emotional Resilience trainingProviding emotional resilience training to the experimental group. |
| Control group | No intervention | –There will be no intervention in the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Emotional Resilience trainingPrimiparous pregnant women in the experimental group will be given emotional resilience training in the last trimester. | Other | Emotional Resilience Group |
Primary outcome
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
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotional Resilience training in people with Fear of Childbirth and Depression, run by Ataturk University at 1 site 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 9 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 22 Apr 2024.