Fear of ChildbirthNCT06503133
The Effect of Prenatal Yoga-Assisted Birth Preparation Training on Fear of Childbirth and Childbirth Self-Efficacy
A study testing Birth preparation training and Prenatal yoga practice in people with Fear of Childbirth and Childbirth Self Efficacy, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
Pregnancy is a life event that requires biopsychosocial adaptation. Although pregnancy is often perceived as a positive and physiological process, women experience a wide range of fears of childbirth, from simple anxiety to severe phobic fear (tokophobia), during their pregnancy. 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
- Fear of Childbirth, Childbirth Self Efficacy
- What is being tested?
- Birth preparation training and Prenatal yoga practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 1 Dec 2025
- 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
- Being primiparous
- Being between the ages of 18 -35
- Having a single and healthy fetus
- 24-32. being in the pregnancy week
- Being no psychiatric diagnosis or treatment
- Using an online meeting program (Zoom®)
Who cannot join
- Women doing body-mind-based exercises (yoga, meditation, progressive muscle relaxation, mindfulness, etc.).
- Women taking birth preparation training
- Women having a regular exercise habit of approximately 90-150 minutes per week
- Women with a high-risk pregnancy diagnosis
- Having become pregnant through assisted reproductive techniques
- According to the Wijma delivery expectancy questionnaire-A scale score, women with severe fear of childbirth will be excluded and referred to psychiatry.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Online Prenatal Yoga-Assisted Birth Preparation Training Based on Albert Bandura's Self-Efficacy Theory on Fear of Childbirth and Childbirth Self-Efficacy in Primiparas: Randomized Controlled Study
Pregnancy is a life event that requires biopsychosocial adaptation. Although pregnancy is often perceived as a positive and physiological process, women experience a wide range of fears of childbirth, from simple anxiety to severe phobic fear (tokophobia), during their pregnancy. It is thought that the feeling of experiencing pain often lies at the root of the fear of childbirth. However, fear of childbirth can be experienced for many different reasons depending on biological, psychological and sociocultural factors, personal characteristics and experiences. The prevalence of fear of childbirth in the world is 14%. In Turkey, the prevalence of fear of childbirth varies between 16% and 69%, and 21% of women experience fear of childbirth at a clinical level. In general, fear is a physiological reaction that is important for the safety of the individual, and it is thought that low-level fear of childbirth will prepare individuals for parenting. However, uncontrollable fear of childbirth can lead to physical, emotional and behavioural changes that negatively affect the woman's daily life, prolonged labour and childbirth complications. Most importantly, women who cannot cope with the fear of childbirth may perceive cesarean section as the only solution and turn to elective cesarean section. The total cesarean section rate in Turkey is 52%, which is much higher than the World Health Organization's acceptable cesarean section rate. Fear of childbirth has been accepted as an important public health problem that needs intervention both in the world and in our country, and research on fear of childbirth has accelerated, especially in the last twenty years.
Read the detailed description
Although there are many factors affecting fear of childbirth, childbirth self-efficacy is among the important predictors of fear of childbirth. Albert Bandura defines self-efficacy as "an individual's belief in his or her ability to engage in behaviour that leads to the desired outcome in a given situation." Bandura divided self-efficacy into two subcomponents, efficacy and outcome expectancy, and tried to explain human behaviour in this way. While efficacy expectancy describes the individual's belief that they can perform certain behaviours successfully (e.g., the woman's belief that she can successfully perform relaxation exercises during labour), outcome expectancy refers to the belief that performing a behaviour will lead to a result. (e.g., the woman's belief that she will experience less pain if she relaxes during labour). Self-efficacy is important in determining the direction of emotions, thoughts and behaviour patterns. For this reason, the "concept of birth self-efficacy" has been defined separately. Childbirth self-efficacy refers to the woman's self-confidence in coping with labour. Women with higher self-efficacy expectations are more likely to initiate and maintain pain-coping strategies. High childbirth self-efficacy is associated with improved perinatal outcomes and maternal health. A woman's self-confidence increases her access to methods of coping with labour and her ability to cope with the fear of birth. For this reason, it is important to associate the resources that nourish the concept of self-efficacy with childbirth. For this reason, Lowe associated self-efficacy resources with childbirth.Prenatal education is accepted as an effective strategy to improve women's self-efficacy during pregnancy. Prenatal education enables expectant mothers to make safe decisions during pregnancy and birth, improves their skills in coping with labour pain, increases birth self-efficacy and reduces the fear of birth. There are also study results showing that prenatal education can affect the type of birth, the use of birth-related interventions, and obstetric outcomes. It is especially important in terms of reducing the rate of interventional childbirth and cesarean sections. In recent years, yoga has been one of the preferred practices in the prenatal period due to its positive physical and psychological effects. Women see yoga as a holistic practice that can meet their needs during pregnancy, birth and the postpartum period. Despite the physiological effects of breathing exercises and yoga postures on the body during yoga practice, studies are often interested in the psychological effects of yoga. However, study results show that yoga performed during pregnancy can reduce pregnancy-related physiological disorders, shorten childbirth times, reduce childbirth pain, and increase childbirth self-efficacy and vaginal birth rate. Yoga provides somatic body awareness, especially with the meditation and breathing exercises it includes. Awareness of the body's physiological and psychological changes increases women's self-efficacy during childbirth. Considering this aspect, there are gaps in the literature regarding the effect of yoga during pregnancy on women's self
- Conditions
- Fear of Childbirth, Childbirth Self Efficacy
- Being tested
- Birth preparation training, Prenatal yoga practice
- Keywords
- Birth preperation training, Prenatal yoga, Fear of childbirth, Childbirth self efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Birth preparation trainingOther
Birth preparation training is based on Albert Bandura's self-efficacy theory. It is a 60-minute training once a week. The first 10 minutes of the training are devoted to the initial activity, 40 minutes to sharing the training content, and 10 minutes to answering the participants' questions and receiving feedback. The training will be conducted in closed groups via the online meeting program (Zoom®).
Prenatal yoga practiceOther
Prenatal yoga practice is a 60-minute practice once a week. The first 5 minutes of the prenatal yoga practice are devoted to guided meditation, 40 minutes to active asanas (yoga pose), 5 minutes to pranayama practice (breathing exercise) and 10 minutes to savasana (relaxing yoga pose). Prenatal yoga practice will be conducted in closed groups via the online meeting program (Zoom®)
| Study group | Role | What they receive |
|---|---|---|
| Prenatal Yoga-Supported Birth preparation Training Group | Experimental | Participants in this group will receive a 6-week prenatal yoga-supported birth preparation training program based on Albert Bandura's self-efficacy theory. Receives: Other: Birth preparation training; Other: Prenatal yoga practice |
| Birth Preparation Training Group | Active comparator | Participants in this group will receive a 6-week birth preparation training program based on Albert Bandura's self-efficacy theory.
After the post-test measurements are taken, participants in this group will also be offered the opportunity to apply prenatal yoga. Receives: Other: Birth preparation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear of Childbirth
Fear of Childbirth (Measurement will be made using the Wijma Birth Expectation/Experience Scale A version. In the 6-point Likert type scale, 0 means "completely", and 5 means "not at all". The lowest score that can be obtained from the scale is 0, while the highest score is 165. It is interpreted that as the score obtained from the scale increases, the fear of birth experienced by women increases.)
Measured: Measurements will be taken at registration when participants are included in the study, and 6 weeks after the first measurement
Childbirth Self Efficacy
Childbirth self-efficacy (Measurements will be made with the Childbirth Self Efficacy Scale-Short Form. The scale has two sub-dimensions. Each item is scored between 1 and 10 on the Likert-type scale. The lowest score on the scale is 32, and the highest If it is high, it is 320 points. As the total score obtained from the scale increases, self-efficacy regarding birth increases.)
Measured: Measurements will be taken at registration when participants are included in the study, and 6 weeks after the first measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Dec 2025 (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.
- 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
- The research is a single-centre parallel randomized controlled experimental study.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Collaborators
- Lokman Hekim University
- Responsible party
- Principal investigator, Eda Simsek Sahin, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06503133
- Sponsor's protocol ID
- E-77082166-302.08.01-664219
- Status last verified
- Jul 2024
- First submitted
- 9 Jul 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to roll out IPD.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Online Prenatal Yoga-Assisted Birth Preparation Training Based on Albert Bandura's Self-Efficacy Theory on Fear of Childbirth and Childbirth Self-Efficacy in Primiparas: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06503133
- Acronym / sponsor ID
- E-77082166-302.08.01-664219
- Conditions
- Fear of Childbirth, Childbirth Self Efficacy
- Keywords
- Birth preperation training, Prenatal yoga, Fear of childbirth, Childbirth self efficacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Collaborators
- Lokman Hekim University
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 16 Jul 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.
Pregnancy is a life event that requires biopsychosocial adaptation. Although pregnancy is often perceived as a positive and physiological process, women experience a wide range of fears of childbirth, from simple anxiety to severe phobic fear (tokophobia), during their pregnancy. It is thought that the feeling of experiencing pain often lies at the root of the fear of childbirth. However, fear of childbirth can be experienced for many different reasons depending on biological, psychological and sociocultural factors, personal characteristics and experiences. The prevalence of fear of childbirth in the world is 14%. In Turkey, the prevalence of fear of childbirth varies between 16% and 69%, and 21% of women experience fear of childbirth at a clinical level. In general, fear is a physiological reaction that is important for the safety of the individual, and it is thought that low-level fear of childbirth will prepare individuals for parenting. However, uncontrollable fear of childbirth can lead to physical, emotional and behavioural changes that negatively affect the woman's daily life, prolonged labour and childbirth complications. Most importantly, women who cannot cope with the fear of childbirth may perceive cesarean section as the only solution and turn to elective cesarean section. The total cesarean section rate in Turkey is 52%, which is much higher than the World Health Organization's acceptable cesarean section rate. Fear of childbirth has been accepted as an important public health problem that needs intervention both in the world and in our country, and research on fear of childbirth has accelerated, especially in the last twenty years.
Detailed description
Although there are many factors affecting fear of childbirth, childbirth self-efficacy is among the important predictors of fear of childbirth. Albert Bandura defines self-efficacy as "an individual's belief in his or her ability to engage in behaviour that leads to the desired outcome in a given situation." Bandura divided self-efficacy into two subcomponents, efficacy and outcome expectancy, and tried to explain human behaviour in this way. While efficacy expectancy describes the individual's belief that they can perform certain behaviours successfully (e.g., the woman's belief that she can successfully perform relaxation exercises during labour), outcome expectancy refers to the belief that performing a behaviour will lead to a result. (e.g., the woman's belief that she will experience less pain if she relaxes during labour). Self-efficacy is important in determining the direction of emotions, thoughts and behaviour patterns. For this reason, the "concept of birth self-efficacy" has been defined separately. Childbirth self-efficacy refers to the woman's self-confidence in coping with labour. Women with higher self-efficacy expectations are more likely to initiate and maintain pain-coping strategies. High childbirth self-efficacy is associated with improved perinatal outcomes and maternal health. A woman's self-confidence increases her access to methods of coping with labour and her ability to cope with the fear of birth. For this reason, it is important to associate the resources that nourish the concept of self-efficacy with childbirth. For this reason, Lowe associated self-efficacy resources with childbirth.Prenatal education is accepted as an effective strategy to improve women's self-efficacy during pregnancy. Prenatal education enables expectant mothers to make safe decisions during pregnancy and birth, improves their skills in coping with labour pain, increases birth self-efficacy and reduces the fear of birth. There are also study results showing that prenatal education can affect the type of birth, the use of birth-related interventions, and obstetric outcomes. It is especially important in terms of reducing the rate of interventional childbirth and cesarean sections. In recent years, yoga has been one of the preferred practices in the prenatal period due to its positive physical and psychological effects. Women see yoga as a holistic practice that can meet their needs during pregnancy, birth and the postpartum period. Despite the physiological effects of breathing exercises and yoga postures on the body during yoga practice, studies are often interested in the psychological effects of yoga. However, study results show that yoga performed during pregnancy can reduce pregnancy-related physiological disorders, shorten childbirth times, reduce childbirth pain, and increase childbirth self-efficacy and vaginal birth rate. Yoga provides somatic body awareness, especially with the meditation and breathing exercises it includes. Awareness of the body's physiological and psychological changes increases women's self-efficacy during childbirth. Considering this aspect, there are gaps in the literature regarding the effect of yoga during pregnancy on women's self
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The research is a single-centre parallel randomized controlled experimental study.
| Arm | Type | Receives |
|---|---|---|
| Prenatal Yoga-Supported Birth preparation Training Group | Experimental | Other: Birth preparation training, Other: Prenatal yoga practiceParticipants in this group will receive a 6-week prenatal yoga-supported birth preparation training program based on Albert Bandura's self-efficacy theory. |
| Birth Preparation Training Group | Active comparator | Other: Birth preparation trainingParticipants in this group will receive a 6-week birth preparation training program based on Albert Bandura's self-efficacy theory. After the post-test measurements are taken, participants in this group will also be offered the opportunity to apply prenatal yoga. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Being primiparous
- Being between the ages of 18 -35
- Having a single and healthy fetus
- 24-32. being in the pregnancy week
- Being no psychiatric diagnosis or treatment
Key exclusion criteria (6 listed)
- Women doing body-mind-based exercises (yoga, meditation, progressive muscle relaxation, mindfulness, etc.).
- Women taking birth preparation training
- Women having a regular exercise habit of approximately 90-150 minutes per week
- Women with a high-risk pregnancy diagnosis
- Having become pregnant through 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 |
|---|---|---|
| Birth preparation trainingBirth preparation training is based on Albert Bandura's self-efficacy theory. It is a 60-minute training once a week. The first 10 minutes of the training are devoted to the initial activity, 40 minutes to sharing the training content, and 10 minutes to answering the participants' questions and receiving feedback. The training will be conducted in closed groups via the online meeting program (Zoom®). | Other | Birth Preparation Training Group, Prenatal Yoga-Supported Birth preparation Training Group |
| Prenatal yoga practicePrenatal yoga practice is a 60-minute practice once a week. The first 5 minutes of the prenatal yoga practice are devoted to guided meditation, 40 minutes to active asanas (yoga pose), 5 minutes to pranayama practice (breathing exercise) and 10 minutes to savasana (relaxing yoga pose). Prenatal yoga practice will be conducted in closed groups via the online meeting program (Zoom®) | Other | Prenatal Yoga-Supported Birth preparation Training Group |
Primary outcome
Fear of Childbirth
Time frame: Measurements will be taken at registration when participants are included in the study, and 6 weeks after the first measurement
Fear of Childbirth (Measurement will be made using the Wijma Birth Expectation/Experience Scale A version. In the 6-point Likert type scale, 0 means "completely", and 5 means "not at all". The lowest score that can be obtained from the scale is 0, while the highest score is 165. It is interpreted that as the score obtained from the scale increases, the fear of birth experienced by women increases.)
Childbirth Self Efficacy
Time frame: Measurements will be taken at registration when participants are included in the study, and 6 weeks after the first measurement
Childbirth self-efficacy (Measurements will be made with the Childbirth Self Efficacy Scale-Short Form. The scale has two sub-dimensions. Each item is scored between 1 and 10 on the Likert-type scale. The lowest score on the scale is 32, and the highest If it is high, it is 320 points. As the total score obtained from the scale increases, self-efficacy regarding birth increases.)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: No. There are no plans to roll out IPD.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Birth preparation training and Prenatal yoga practice in people with Fear of Childbirth and Childbirth Self Efficacy, run by Kocaeli 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 6 inclusion and 6 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 23 Jul 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?
Contact Eda SIMSEK SAHIN ((0262) 303 47 01 ext. 47 09, simsekeda24@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear of Childbirth (time frame: Measurements will be taken at registration when participants are included in the study, and 6 weeks after the first measurement). 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 23 Jul 2024; AzTrials last refreshed its copy on 26 Oct 2026.