- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06503133
The Effect of Prenatal Yoga-Assisted Birth Preparation Training on Fear of Childbirth and Childbirth Self-Efficacy
July 21, 2024 updated by: Eda Simsek Sahin, Kocaeli University
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Eda SIMSEK SAHIN
- Phone Number: 47 09 (0262) 303 47 01
- Email: simsekeda24@gmail.com
Study Locations
-
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İ̇zmi̇t
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Kocaeli, İ̇zmi̇t, Turkey, 41100
- Kocaeli University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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®)
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Prenatal Yoga-Supported Birth preparation Training Group
Participants 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 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 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®)
|
|
Active Comparator: Birth Preparation Training Group
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. |
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®).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.)
|
Measurements will be taken at registration when participants are included in the study, and 6 weeks after the first measurement
|
|
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.)
|
Measurements will be taken at registration when participants are included in the study, and 6 weeks after the first measurement
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2024
Primary Completion (Estimated)
June 1, 2025
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
July 9, 2024
First Submitted That Met QC Criteria
July 9, 2024
First Posted (Actual)
July 16, 2024
Study Record Updates
Last Update Posted (Actual)
July 23, 2024
Last Update Submitted That Met QC Criteria
July 21, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- E-77082166-302.08.01-664219
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There are no plans to roll out IPD.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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