Birth, FirstNCT05115071
Online Childbirth Preparation Education in Covid-19 Pandemic
A study testing Childbirth preparation education in people with Birth, First and COVID-19, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Today, pregnancy and childbirth are important life events that involve many difficulties and changes that must be overcome for both men and women. During this process, changes occur in the pregnant woman's body, emotional state and family life. 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
- Birth, First, COVID-19, Fear of Childbirth
- What is being tested?
- Childbirth preparation education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Nov 2021to 10 Dec 2021
- 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
- Be over 18 years old
- Volunteering to participate in research
- Be at 24-34 weeks of gestation
- Be nulliparous
- Not having a high risk pregnancy
- Be able to read and write Turkish
- Be able to fill out an online survey form
- Planning to have a normal spontaneous vaginal delivery
Who cannot join
- Be under the age of 18
- Not completing eight hours of childbirth preparation education
- Having a mental disorder that prevents answering survey questions
- Having a psychiatric illness
- Be able not use Microsoft Teams app
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Online Childbirth Preparation Education in Pregnancy on Worries and Fear of Birth, Preparation for Birth, and Well-being of Self and Baby in the Covid 19 Pandemic
Today, pregnancy and childbirth are important life events that involve many difficulties and changes that must be overcome for both men and women. During this process, changes occur in the pregnant woman's body, emotional state and family life. These changes often cause pregnant women to experience anxiety about the baby's health and their own health, and to create new stressful situations. Adding the pandemic conditions to this situation further complicates the process and it is seen that the fears of women towards the birth and postpartum period will increase even more. Childbirth preparation classes reduce the fear and anxiety of women and create a positive perception of birth. For this reason, it is more important to give birth preparation education to women during in pregnancy during the pandemic period. However, it is not possible to give face-to-face birth preparation education to women in this process. For this reason, the aim of this study is to examine the effect of online childbirth preparation education in pregnancy on worries and fear of birth, preparation for birth, and well-being of self and baby in the Covid 19 pandemic.
The research is a pre-post test randomized controlled experimental study. The block randomization method will be used. The universe of the research will consist of women who applied to Pamukkale University Research and Application Hospital pregnant outpatient clinic, and have a healthy pregnancy at 24-34 weeks of gestation. The education will be done online. The sample size was calculated in the G*power statistics program using the data of a study in which the childbirth preparation education intervention was previously performed (α =0.05, d=1.05). Accordingly, it was found that 16 people should be taken for each group to sampling for 80% power. Considering that there might be losses, the number of samples was increased by 10% and it was planned to include a total of 36 people in the study. Intention-to-treat analysis will be performed to manage bias and losses.
- Conditions
- Birth, First, COVID-19, Fear of Childbirth
- Being tested
- Childbirth preparation education
- Keywords
- online childbirth preparation, fear of childbirth, worries on birth, preparation for birth, well-being of self and baby, Covid 19 pandemic
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Childbirth preparation educationBehavioural
Purpose: The aim of the birth preparation education is to eliminate the fears and concerns of pregnant women about birth and to prepare them for birth during the Covid-19 Pandemic process.
Education hours: The education will be completed in total two weeks and eight hours, consisting of two days and four hours each week.
Method: The education will be given online through the Microsoft Teams application. Each training day will consist of two lessons. Each lesson will last 45 minutes. There will be a 15-minute break between the two lessons. The first lesson will be conducted in the form of a question and answer session with a power-point presentation.In the second lesson, relaxation exercises will be applicated and evaluations will be taken at the end of the lesson.
The group that will receive the education: Healthy pregnant women between 24-34 weeks of gestation will be included in the training. Trainings will continue with closed groups.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Not described Receives: Behavioral: Childbirth preparation education |
| No intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford Worries on Labour Scale (OWLS)
The scale will be filled online by each pregnant woman before and after the education. The scale is used to evaluate concerns about the birth process and consists of 10 items. Scoring is done between 1-4. The scale consists of 3 sub-dimensions. There is no reverse scored item. The points that can be taken are min:10, max:40. As the score increases, it is interpreted that the anxiety level of women decreases.
Measured: Change from baseline Oxford Worries on Labour score at 2 weeks
Prenatal Self Evaluation Questionnaire (PSEQ)-Preparation for labor subscale
The scale will be filled online by each pregnant woman before and after the education. The scale was developed to evaluate the adaptation of women in the prenatal period to motherhood. The scale consists of 7 sub-dimensions and a total of 79 items. Scoring is done between 1-4. Items 7, 13, 24, 25, 26, 38, 47, 48, 56, 72 belong to the Preparation for Labor subscale. There are reversed items in the scale. Low scores indicate high compliance to pregnancy.
Measured: Change from baseline Preparation for Labor score at 2 weeks
Prenatal Self Evaluation Questionnaire (PSEQ)-Well-being of self and baby subscale
The scale will be filled online by each pregnant woman before and after the education.The scale was developed to evaluate the adaptation of women in the prenatal period to motherhood. The scale consists of 7 sub-dimensions and a total of 79 items. Scoring is done between 1-4. The scale was developed to evaluate the adaptation of women in the prenatal period to motherhood. The scale consists of 7 sub-dimensions and a total of 79 items. Scoring is done between 1-4. Items 12, 16, 17, 30, 41, 51, 57, 63, 68, 71 belong to the Well-Being of Self and Baby subscale. There are reversed items in the scale. Low scores indicate high compliance with pregnancy.
Measured: Change from baseline Well-being of Self and Baby score at 2 weeks
Fear of Birth Scale (FOBS)
The scale will be filled online by each pregnant woman before and after the education. The scale was developed to measure the fear of childbirth. In the scale, the participants asked the question "How do you feel about the upcoming birth right now?" In response to the question, they are asked to rate their emotions by marking them on two 100 mm lines defined as (a) 'calm and anxious', (b) 'no fear and severe fear'. The cut-off point of the scale is 50 points. It has been defined that people who score 50 and above experience fear of childbirth. The scale can be applied to both pregnant women and their partners. Scoring of the scale: The scores marked on two 100 mm lines are summed and divided into two. The resulting score gives the FOBS score of the pregnant or spouse who answered the scale. Individuals with a score of 50 and above are considered to have fear of childbirth.
Measured: Change from baseline Fear of Birth score at 2 weeks
The Fear of COVID-19 Scale (FCV-19S)
The scale will be filled online by each pregnant woman before and after the education. The scale is used to measure fear of Covid-19. The scale consists of one dimension and 7 items. Scoring is done between 1-5. There is no reverse scored item. The points that can be taken are min:7, max:35. An increase in the score obtained from the scale means an increase in the fear of Covid-19.
Measured: Change from baseline Fear of Covid-19 score at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start8 Nov 2021
- Primary completion25 Nov 2021
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Birth, FirstStudies of the same condition, open and under way.
- More trials run by Pamukkale 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
- Single blind pre-post test randomized controlled design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Okan Vardar, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05115071
- Sponsor's protocol ID
- E-60116787-020-10516
- Status last verified
- Dec 2021
- First submitted
- 6 Nov 2021
- Last updated
- 15 Dec 2021
- 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 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Online Childbirth Preparation Education in Pregnancy on Worries and Fear of Birth, Preparation for Birth, and Well-being of Self and Baby in the Covid 19 Pandemic
- ClinicalTrials.gov ID
- NCT05115071
- Acronym / sponsor ID
- E-60116787-020-10516
- Conditions
- Birth, First, COVID-19, Fear of Childbirth
- Keywords
- online childbirth preparation, fear of childbirth, worries on birth, preparation for birth, well-being of self and baby, Covid 19 pandemic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 25 Nov 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 10 Nov 2021 (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.
Today, pregnancy and childbirth are important life events that involve many difficulties and changes that must be overcome for both men and women. During this process, changes occur in the pregnant woman's body, emotional state and family life. These changes often cause pregnant women to experience anxiety about the baby's health and their own health, and to create new stressful situations. Adding the pandemic conditions to this situation further complicates the process and it is seen that the fears of women towards the birth and postpartum period will increase even more. Childbirth preparation classes reduce the fear and anxiety of women and create a positive perception of birth. For this reason, it is more important to give birth preparation education to women during in pregnancy during the pandemic period. However, it is not possible to give face-to-face birth preparation education to women in this process. For this reason, the aim of this study is to examine the effect of online childbirth preparation education in pregnancy on worries and fear of birth, preparation for birth, and well-being of self and baby in the Covid 19 pandemic.
The research is a pre-post test randomized controlled experimental study. The block randomization method will be used. The universe of the research will consist of women who applied to Pamukkale University Research and Application Hospital pregnant outpatient clinic, and have a healthy pregnancy at 24-34 weeks of gestation. The education will be done online. The sample size was calculated in the G*power statistics program using the data of a study in which the childbirth preparation education intervention was previously performed (α =0.05, d=1.05). Accordingly, it was found that 16 people should be taken for each group to sampling for 80% power. Considering that there might be losses, the number of samples was increased by 10% and it was planned to include a total of 36 people in the study. Intention-to-treat analysis will be performed to manage bias and losses.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single blind pre-post test randomized controlled design
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Childbirth preparation education |
| No intervention | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be over 18 years old
- Volunteering to participate in research
- Be at 24-34 weeks of gestation
- Be nulliparous
- Not having a high risk pregnancy
Key exclusion criteria (5 listed)
- Be under the age of 18
- Not completing eight hours of childbirth preparation education
- Having a mental disorder that prevents answering survey questions
- Having a psychiatric illness
- Be able not use Microsoft Teams app
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 preparation educationPurpose: The aim of the birth preparation education is to eliminate the fears and concerns of pregnant women about birth and to prepare them for birth during the Covid-19 Pandemic process. Education hours: The education will be completed in total two weeks and eight hours, consisting of two days and four hours each week. Method: The education will be given online through the Microsoft Teams application. Each training day will consist of two lessons. Each lesson will last 45 minutes. There will be a 15-minute break between the two lessons. The first lesson will be conducted in the form of a question and answer session with a power-point presentation.In the second lesson, relaxation exercises will be applicated and evaluations will be taken at the end of the lesson. The group that will receive the education: Healthy pregnant women between 24-34 weeks of gestation will be included in the training. Trainings will continue with closed groups. | Behavioural | Experimental |
Primary outcome
Oxford Worries on Labour Scale (OWLS)
Time frame: Change from baseline Oxford Worries on Labour score at 2 weeks
The scale will be filled online by each pregnant woman before and after the education. The scale is used to evaluate concerns about the birth process and consists of 10 items. Scoring is done between 1-4. The scale consists of 3 sub-dimensions. There is no reverse scored item. The points that can be taken are min:10, max:40. As the score increases, it is interpreted that the anxiety level of women decreases.
Prenatal Self Evaluation Questionnaire (PSEQ)-Preparation for labor subscale
Time frame: Change from baseline Preparation for Labor score at 2 weeks
The scale will be filled online by each pregnant woman before and after the education. The scale was developed to evaluate the adaptation of women in the prenatal period to motherhood. The scale consists of 7 sub-dimensions and a total of 79 items. Scoring is done between 1-4. Items 7, 13, 24, 25, 26, 38, 47, 48, 56, 72 belong to the Preparation for Labor subscale. There are reversed items in the scale. Low scores indicate high compliance to pregnancy.
Prenatal Self Evaluation Questionnaire (PSEQ)-Well-being of self and baby subscale
Time frame: Change from baseline Well-being of Self and Baby score at 2 weeks
The scale will be filled online by each pregnant woman before and after the education.The scale was developed to evaluate the adaptation of women in the prenatal period to motherhood. The scale consists of 7 sub-dimensions and a total of 79 items. Scoring is done between 1-4. The scale was developed to evaluate the adaptation of women in the prenatal period to motherhood. The scale consists of 7 sub-dimensions and a total of 79 items. Scoring is done between 1-4. Items 12, 16, 17, 30, 41, 51, 57, 63, 68, 71 belong to the Well-Being of Self and Baby subscale. There are reversed items in the scale. Low scores indicate high compliance with pregnancy.
Fear of Birth Scale (FOBS)
Time frame: Change from baseline Fear of Birth score at 2 weeks
The scale will be filled online by each pregnant woman before and after the education. The scale was developed to measure the fear of childbirth. In the scale, the participants asked the question "How do you feel about the upcoming birth right now?" In response to the question, they are asked to rate their emotions by marking them on two 100 mm lines defined as (a) 'calm and anxious', (b) 'no fear and severe fear'. The cut-off point of the scale is 50 points. It has been defined that people who score 50 and above experience fear of childbirth. The scale can be applied to both pregnant women and their partners. Scoring of the scale: The scores marked on two 100 mm lines are summed and divided into two. The resulting score gives the FOBS score of the pregnant or spouse who answered the scale. Individuals with a score of 50 and above are considered to have fear of childbirth.
The Fear of COVID-19 Scale (FCV-19S)
Time frame: Change from baseline Fear of Covid-19 score at 2 weeks
The scale will be filled online by each pregnant woman before and after the education. The scale is used to measure fear of Covid-19. The scale consists of one dimension and 7 items. Scoring is done between 1-5. There is no reverse scored item. The points that can be taken are min:7, max:35. An increase in the score obtained from the scale means an increase in the fear of Covid-19.
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 15 Dec 2021.
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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 Childbirth preparation education in people with Birth, First and COVID-19, run by Pamukkale 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 8 inclusion and 5 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 15 Dec 2021. 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?
Oxford Worries on Labour Scale (OWLS) (time frame: Change from baseline Oxford Worries on Labour score at 2 weeks). The study lists 5 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 15 Dec 2021.