Pregnancy RelatedNCT04525430
Childbirth Education and Birth Plan on Birth Self Efficacy in Pregnant Women
A study testing childbirth education and childbirth education and was subjected to a birth plan in people with Pregnancy Related and Self Efficacy, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
The pregnant women constituting the sample were divided into 3 groups. Group 1 was given only childbirth education (Group-ED), group 2 was given childbirth education and was subjected to a birth plan (Group-ED\&P), and group 3 was the control group, each including 51 pregnant women. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Self Efficacy
- What is being tested?
- childbirth education and childbirth education and was subjected to a birth plan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2017to 1 Sep 2017
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- pregnant women who was in the third trimester (28-40 gestational weeks),
- who was literate or had a relative/helper who would write a birth plan to be prepared,
- who were not involved in any diagnosed risk at the present pregnancy (such as preeclampsia, diabetes, heart disease, placenta previa, oligohydramnios and multiple pregnancy)
- who did not have any diagnosed problems with the health of fetus (such as fetal anomaly and intrauterine growth retardation).
Who cannot join
- who had previous cesarean section were not included in the research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Childbirth Education and Birth Plan With Childbirth Education Alone on Childbirth Self-Efficacy: A Randomized Controlled Trial
The pregnant women constituting the sample were divided into 3 groups. Group 1 was given only childbirth education (Group-ED), group 2 was given childbirth education and was subjected to a birth plan (Group-ED\&P), and group 3 was the control group, each including 51 pregnant women.
Read the detailed description
Aim: The purpose of this study was to investigate how pregnant women's childbirth self-efficacy was affected by childbirth education and birth plans applied with the education.
Methods: The research was carried out at seven Family Health Centers in Turkey as a randomized controlled trial. The pregnant women constituting the sample were divided into 3 groups. Group 1 was given only childbirth education (Group-ED), group 2 was given childbirth education and was subjected to a birth plan (Group-ED\&P), and group 3 was the control group, each including 51 pregnant women.
- Conditions
- Pregnancy Related, Self Efficacy
- Being tested
- childbirth education, childbirth education and was subjected to a birth plan
- Keywords
- pregnancy, childbirth education, birth plan, self efficacy, midwifery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
childbirth educationOther
Also called group-ED
The 1st Session: General information about labor: Factors affecting labor, early signs of labor, signs of the start of labor, steps of labor, and procedures applied during labor.
The 2nd Session: Methods of coping with birth contractions: Breathing exercises, relaxation exercises, massage, changing position, music, cold/warm application, focus, and walking.
childbirth education and was subjected to a birth planOther
Also called Group-ED&P
In the birth plan created by the researchers, the pregnant women considered the process from the start of labor to the end of labor and marked the expectation from and preferences about this process on the birth plan.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | only childbirth education group Receives: Other: childbirth education |
| Group 2 | Experimental | childbirth education and was subjected to a birth plan group Receives: Other: childbirth education and was subjected to a birth plan |
| Group 3 | No intervention | standard care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in birth self-efficacy level at 2 weeks (after intervention).
Childbirth Self-Efficacy was measured with Childbirth Self-Efficacy Inventory (CBSEI) Short Version. The scale consisted of two sub-dimensions, self-efficacy expectancy and outcome expectancy. The highest score to be taken from the sub-dimensions was 160, and the lowest score was 16. Pregnant women's having a high score on this scale meant that the level of their childbirth self-efficacy was high.
Measured: CBSEI was administered as a pretest to all pregnant women in the three groups. After two weeks CBSEI was administered as a posttest to the pregnant women in all three groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start1 Apr 2017
- Primary completion1 Jun 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Inonu 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
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zeliha sunay, Inonu University
- Investigators
- zeliha sunay, Msc, Principal investigator, munzur üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04525430
- Sponsor's protocol ID
- 2017/4-3
- Status last verified
- Jan 2022
- First submitted
- 9 Aug 2020
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: we don't share individual participant data with other researchers
Publications
Aragon M, Chhoa E, Dayan R, Kluftinger A, Lohn Z, Buhler K. Perspectives of expectant women and health care providers on birth plans. J Obstet Gynaecol Can. 2013 Nov;35(11):979-985. doi: 10.1016/S1701-2163(15)30785-4.
PubMed 24246397
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Childbirth Education and Birth Plan With Childbirth Education Alone on Childbirth Self-Efficacy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04525430
- Acronym / sponsor ID
- 2017/4-3
- Conditions
- Pregnancy Related, Self Efficacy
- Keywords
- pregnancy, childbirth education, birth plan, self efficacy, midwifery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 25 Aug 2020 (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.
The pregnant women constituting the sample were divided into 3 groups. Group 1 was given only childbirth education (Group-ED), group 2 was given childbirth education and was subjected to a birth plan (Group-ED\&P), and group 3 was the control group, each including 51 pregnant women.
Detailed description
Aim: The purpose of this study was to investigate how pregnant women's childbirth self-efficacy was affected by childbirth education and birth plans applied with the education.
Methods: The research was carried out at seven Family Health Centers in Turkey as a randomized controlled trial. The pregnant women constituting the sample were divided into 3 groups. Group 1 was given only childbirth education (Group-ED), group 2 was given childbirth education and was subjected to a birth plan (Group-ED\&P), and group 3 was the control group, each including 51 pregnant women.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: childbirth educationonly childbirth education group |
| Group 2 | Experimental | Other: childbirth education and was subjected to a birth planchildbirth education and was subjected to a birth plan group |
| Group 3 | No intervention | –standard care group |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- pregnant women who was in the third trimester (28-40 gestational weeks),
- who was literate or had a relative/helper who would write a birth plan to be prepared,
- who were not involved in any diagnosed risk at the present pregnancy (such as preeclampsia, diabetes, heart disease, placenta previa, oligohydramnios and multiple pregnancy)
- who did not have any diagnosed problems with the health of fetus (such as fetal anomaly and intrauterine growth retardation).
Key exclusion criteria (1 listed)
- who had previous cesarean section were not included in the research.
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 |
|---|---|---|
| childbirth educationAlso: group-EDThe 1st Session: General information about labor: Factors affecting labor, early signs of labor, signs of the start of labor, steps of labor, and procedures applied during labor. The 2nd Session: Methods of coping with birth contractions: Breathing exercises, relaxation exercises, massage, changing position, music, cold/warm application, focus, and walking. | Other | Group 1 |
| childbirth education and was subjected to a birth planAlso: Group-ED&PIn the birth plan created by the researchers, the pregnant women considered the process from the start of labor to the end of labor and marked the expectation from and preferences about this process on the birth plan. | Other | Group 2 |
Primary outcome
Change in birth self-efficacy level at 2 weeks (after intervention).
Time frame: CBSEI was administered as a pretest to all pregnant women in the three groups. After two weeks CBSEI was administered as a posttest to the pregnant women in all three groups.
Childbirth Self-Efficacy was measured with Childbirth Self-Efficacy Inventory (CBSEI) Short Version. The scale consisted of two sub-dimensions, self-efficacy expectancy and outcome expectancy. The highest score to be taken from the sub-dimensions was 160, and the lowest score was 16. Pregnant women's having a high score on this scale meant that the level of their childbirth self-efficacy was high.
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 11 Jan 2022.
- Results publication: PubMed 24246397Aragon M, Chhoa E, Dayan R, Kluftinger A, Lohn Z, Buhler K. Perspectives of expectant women and health care providers on birth plans. J Obstet Gynaecol Can. 2013 Nov;35(11):979-985. doi: 10.1016/S1701-2163(15)30785-4.
- citation linkLink provided by the sponsor.
- Individual participant dataSharing planned: No. we don't share individual participant data with other researchers
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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.
zeliha sunay, Msc principal investigator
munzur üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing childbirth education and childbirth education and was subjected to a birth plan in people with Pregnancy Related and Self Efficacy, run by Inonu 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 4 inclusion and 1 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 11 Jan 2022. 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?
Change in birth self-efficacy level at 2 weeks (after intervention). (time frame: CBSEI was administered as a pretest to all pregnant women in the three groups. After two weeks CBSEI was administered as a posttest to the pregnant women in all three groups.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04525430, which also lists 1 linked publication.
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 11 Jan 2022.