BirthNCT05928117
Training Given in the Line of Coping With Fear of Birth on Fear of Birth Birth Experience
A study testing Education in people with Birth and Fear of Childbirth, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
Pregnancy and childbirth are a natural life event for women, as well as a process in which physical, biological and psychosocial changes are experienced. This process causes women to perceive childbirth as an unknown and unpredictable situation, resulting in the fear of childbirth. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Birth, Fear of Childbirth, Education
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 1 Sep 2023
- 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 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Primiparous,
- Having a single fetus,
- Able to read and write,
- Between the ages of 18-35,
- Volunteer to participate in the research,
- 28-30 days of pregnancy according to the last menstrual period or ultrasonography records. in the week,
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- No risk factors (heart disease, placenta previa, oligohydramnios, preeclampsia, anhydramnios, diabetes, epilepsy),
- Having a telephone that can be contacted for mobile calls,
- Pregnant women who do not have any disability diagnosed for normal delivery.
Who cannot join
- Having communication problems,
- Having mental deficiency,
- Those who received infertility treatment and became pregnant with assisted reproductive techniques.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mobile Training Given in the Line of Coping With Fear of Birth on Fear of Birth, Birth Preference and Birth Experience
Pregnancy and childbirth are a natural life event for women, as well as a process in which physical, biological and psychosocial changes are experienced. This process causes women to perceive childbirth as an unknown and unpredictable situation, resulting in the fear of childbirth. Due to the fear of childbirth, the daily routines, professional lives, social activities and relationships of pregnant women are significantly affected.
This study was planned to evaluate the effect of mobile education given in line with the "Guide to Coping with Fear of Birth" on fear of birth, birth preference and maternal satisfaction at birth. Research; It will be carried out at the T. C. Ministry of Health Gaziantep Cengiz Gökçek Gynecology and Pediatrics Hospital. Data; The first one is 28-30th of pregnancy. week, the second is 36-38. It will meet in three meetings in total, the third of which will be within 12-24 hours postpartum. Data, Personal Information Form (Annex-1), Wijma Birth Expectation/Experience Scale (W-DEQ) Version A (Annex-2), Wijma Birth Expectation/Experience Scale Version B (Annex-3) and Birth Experience Scale ( Annex-4) and Postpartum Questionnaire (Annex-5). The obtained data will be analyzed with the SPSS 22.0 program.
In this study, it is thought that the training given to women with a high level of birth fear can reduce their fear of childbirth and increase maternal satisfaction at birth.
Read the detailed description
The study is a randomized controlled management type study conducted to determine the effect of individual mobile training, which is reached by the "Guidelines for Coping with Fear of Birth" for primitive pregnant women.
Pregnancy and childbirth are a natural life event for women, as well as a process in which physical, biological and psychosocial changes are experienced. This process causes women to perceive childbirth as an unknown and unpredictable situation, resulting in the fear of childbirth. Due to the fear of childbirth, the daily routines, professional lives, social activities and relationships of pregnant women are significantly affected.
This study was planned to evaluate the effect of mobile education given in line with the "Guide to Coping with Fear of Birth" on fear of birth, birth preference and maternal satisfaction at birth. Research; It will be carried out at the T. C. Ministry of Health Gaziantep Cengiz Gökçek Gynecology and Pediatrics Hospital. Data; The first one is 28-30th of pregnancy. week, the second is 36-38. It will meet in three meetings in total, the third of which will be within 12-24 hours postpartum. Data, Personal Information Form (Annex-1), Wijma Birth Expectation/Experience Scale (W-DEQ) Version A (Annex-2), Wijma Birth Expectation/Experience Scale Version B (Annex-3) and Birth Experience Scale ( Annex-4) and Postpartum Questionnaire (Annex-5).
- Conditions
- Birth, Fear of Childbirth, Education, Pregnancy, Fear
- Being tested
- Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
Also called Training to cope with the fear of childbirth education
Pregnant women will be given training to cope with the fear of childbirth.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Intervention: Mobile education given in the line of coping with fear The first one is 28-30th of pregnancy. week, the second is 36-38. It will meet in three meetings in total, the third of which will be within 12-24 hours postpartum. Receives: Other: Education |
| Control | No intervention | Standart care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear of birth
As the scale score increases, the fear of birth increases
Measured: Pre-test: Wijma Birth Fear/Experience version A and B were applied between 28-30 weeks of pregnancy. Post-test: Wijma Birth Fear/Experience version A and B were applied between 36-38 weeks.
Birth experience
As the score obtained from the scale increases, the mother has a good birth experience.
Measured: Birth experience scale was applied between 12-24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Aug 2022
- Primary completion1 Aug 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BirthStudies of the same condition, open and under way.
- More trials run by Cukurova 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
- Model description
- Experimental and control groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Akbaş, Cukurova University
- Investigators
- Meltem Akbaş, PhD, Principal investigator, Universty Of Cukurova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928117
- Sponsor's protocol ID
- 10.09.2021/49
- Status last verified
- Sep 2023
- First submitted
- 23 Jun 2023
- Last updated
- 8 Sep 2023
- 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 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mobile Training Given in the Line of Coping With Fear of Birth on Fear of Birth, Birth Preference and Birth Experience
- ClinicalTrials.gov ID
- NCT05928117
- Acronym / sponsor ID
- 10.09.2021/49
- Conditions
- Birth, Fear of Childbirth, Education, Pregnancy, Fear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 3 Jul 2023 (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.
Pregnancy and childbirth are a natural life event for women, as well as a process in which physical, biological and psychosocial changes are experienced. This process causes women to perceive childbirth as an unknown and unpredictable situation, resulting in the fear of childbirth. Due to the fear of childbirth, the daily routines, professional lives, social activities and relationships of pregnant women are significantly affected.
This study was planned to evaluate the effect of mobile education given in line with the "Guide to Coping with Fear of Birth" on fear of birth, birth preference and maternal satisfaction at birth. Research; It will be carried out at the T. C. Ministry of Health Gaziantep Cengiz Gökçek Gynecology and Pediatrics Hospital. Data; The first one is 28-30th of pregnancy. week, the second is 36-38. It will meet in three meetings in total, the third of which will be within 12-24 hours postpartum. Data, Personal Information Form (Annex-1), Wijma Birth Expectation/Experience Scale (W-DEQ) Version A (Annex-2), Wijma Birth Expectation/Experience Scale Version B (Annex-3) and Birth Experience Scale ( Annex-4) and Postpartum Questionnaire (Annex-5). The obtained data will be analyzed with the SPSS 22.0 program.
In this study, it is thought that the training given to women with a high level of birth fear can reduce their fear of childbirth and increase maternal satisfaction at birth.
Detailed description
The study is a randomized controlled management type study conducted to determine the effect of individual mobile training, which is reached by the "Guidelines for Coping with Fear of Birth" for primitive pregnant women.
Pregnancy and childbirth are a natural life event for women, as well as a process in which physical, biological and psychosocial changes are experienced. This process causes women to perceive childbirth as an unknown and unpredictable situation, resulting in the fear of childbirth. Due to the fear of childbirth, the daily routines, professional lives, social activities and relationships of pregnant women are significantly affected.
This study was planned to evaluate the effect of mobile education given in line with the "Guide to Coping with Fear of Birth" on fear of birth, birth preference and maternal satisfaction at birth. Research; It will be carried out at the T. C. Ministry of Health Gaziantep Cengiz Gökçek Gynecology and Pediatrics Hospital. Data; The first one is 28-30th of pregnancy. week, the second is 36-38. It will meet in three meetings in total, the third of which will be within 12-24 hours postpartum. Data, Personal Information Form (Annex-1), Wijma Birth Expectation/Experience Scale (W-DEQ) Version A (Annex-2), Wijma Birth Expectation/Experience Scale Version B (Annex-3) and Birth Experience Scale ( Annex-4) and Postpartum Questionnaire (Annex-5).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Experimental and control groups
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: EducationIntervention: Mobile education given in the line of coping with fear The first one is 28-30th of pregnancy. week, the second is 36-38. It will meet in three meetings in total, the third of which will be within 12-24 hours postpartum. |
| Control | No intervention | –Standart care |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Primiparous,
- Having a single fetus,
- Able to read and write,
- Between the ages of 18-35,
- Volunteer to participate in the research,
Key exclusion criteria (3 listed)
- Having communication problems,
- Having mental deficiency,
- Those who received infertility treatment and became pregnant with assisted reproductive techniques.
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 |
|---|---|---|
| EducationAlso: Training to cope with the fear of childbirth educationPregnant women will be given training to cope with the fear of childbirth. | Other | Experimental |
Primary outcome
Fear of birth
Time frame: Pre-test: Wijma Birth Fear/Experience version A and B were applied between 28-30 weeks of pregnancy. Post-test: Wijma Birth Fear/Experience version A and B were applied between 36-38 weeks.
As the scale score increases, the fear of birth increases
Birth experience
Time frame: Birth experience scale was applied between 12-24 hour
As the score obtained from the scale increases, the mother has a good birth experience.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- 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. This study is not recruiting at the moment.
Meltem Akbaş, PhD principal investigator
Universty Of Cukurova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Birth and Fear of Childbirth, run by Cukurova 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: finished, as of the sponsor's last update on 8 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fear of birth (time frame: Pre-test: Wijma Birth Fear/Experience version A and B were applied between 28-30 weeks of pregnancy. Post-test: Wijma Birth Fear/Experience version A and B were applied between 36-38 weeks.). The study lists 2 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 Sep 2023.