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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
    • İ̇zmi̇t
      • Kocaeli, İ̇zmi̇t, Turkey, 41100
        • Kocaeli University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Birth preparation training
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®).
Other: Prenatal yoga practice
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.
Other: Birth preparation training
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kocaeli University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Lokman Hekim Üniversitesi

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings