The Effect of Antenatal Education on Fear of Birth, Physiological Ability to Give Birth and Traumatic Birth Perception

January 8, 2024 updated by: Sinem Göral Türkcü, Assistant Prof., Pamukkale University

The Effect of Antenatal Education on Fear of Birth, Physiological Ability to Give Birth and Traumatic Birth Perception: A Randomised Controlled Study

Today, pregnancy and childbirth are important life events that involve many challenges and changes for both men and women. During this process, changes occur in the pregnant woman's body, emotional state and family life. These changes often lead to anxiety about the health of the baby and her own health and to the creation of new stressful situations. During antenatal education, deep relaxation and breathing techniques taught to pregnant women during labour and delivery allow the mother to relax and cope with birth pains more easily and on her own. There are not enough studies in the literature to evaluate the effectiveness of online antenatal classes. In cases where face-to-face antenatal education is not possible during pregnancy, online education is an important option. In the literature, there is no study evaluating how antenatal education affects women's fear of childbirth, physiological ability to give birth and traumatic birth perception together. Therefore, the aim of this study is to examine the effect of antenatal education on fear of childbirth, physiological ability to give birth and perception of traumatic birth. The type of the study is a randomised controlled experimental study with pre-post and control group. The research will be conducted in the form of online training meetings on pregnant women reached through social media. The population of the study will consist of healthy pregnant women who apply to the researchers as a result of the announcements made through social media and who are at the 20th gestational week at the earliest. The sample size was determined by t-test analysis in independent groups in G*power statistical programme, based on two variables, 0.05 significance level, 80% power and medium effect (0.50). Accordingly, a total of 42 pregnant women, 21 pregnant women in each group, are planned to be included in the study. Intention-to-treat analysis will be performed to prevent bias and losses. As an intervention programme, a total of three weeks and six hours of childbirth preparation training will be given, two hours each week. The programme has been prepared by faculty members who have conducted childbirth preparation classes, based on the literature and by making use of childbirth preparation philosophies and methods.

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.

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.
42

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.
  • Name: Sinem Göral Türkcü, Phd, RN, Assist Prof.
  • Phone Number: 05453214007
  • Email: goralsinem@gmail.com

Study Locations

  • Turkey
    • Kınıklı
      • Denizli, Kınıklı, Turkey, 20160
        • Pamukkale University Faculty of Health Sciences

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Voluntary acceptance to participate in the research
  • Being over 18 years of age
  • Being at the 20th gestational week at the earliest.
  • Not carrying a high risk in pregnancy
  • Nulliparity
  • Expected to have a normal spontaneous labour

Exclusion Criteria:

  • Refusal to participate in the research
  • Failure to complete six hours of the childbirth preparation class
  • Inability to use the Zoom application
  • Psychiatric illness

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: Single

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.
No Intervention: No intervention
Experimental: Experimental
Behavioral: Antenatal training

Training hours: Training will be completed in a total of three weeks and six hours, two hours each week.

Method: The training will be given online via Zoom application. The training will consist of a total of three weeks and six hours, two hours each week. "Informed Voluntary Consent Form" will be obtained from individuals in both groups. Pregnant women in both the control and intervention groups will be asked to fill out the "Women's Introductory Information Form". The data of the intervention group will be filled out before the first Antenatal education lesson and after all six-hour Antenatal education lessons are completed. The data of the control group will be filled in parallel with the intervention group.

Group to receive the training: Healthy pregnant women who are at the 20th gestational week at the earliest will be included in the training. Trainings will be carried out in closed groups.

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
Introductory Information Form
Time Frame: Baseline (It will be applied before starting the intervention)
This form, which was developed in line with the literature, consists of 9 questions to obtain some socio-demographic characteristics and obstetric information of pregnant women.
Baseline (It will be applied before starting the intervention)
Preparation for Labor and Birth (P-LAB) Instrument
Time Frame: Baseline (It will be applied before starting the intervention)
The Preparation for Labor and Birth (P-LAB) Instrument was developed by Neerland and colleagues (Neerland et al., 2020). It was conducted to determine the confidence of pregnant women in their physiological ability to give birth. The scale is 5-point Likert type and consists of 22 items. The scale consists of four sub-dimensions. The Turkish validity and reliability study of the scale was conducted by Uludağ and Uçtu (2022). Cronbach's alpha value is above 0.70 for all scales and subscales.
Baseline (It will be applied before starting the intervention)
Traumatic Birth Perception Scale
Time Frame: Baseline (It will be applied before starting the intervention)
The scale developed by Yalnız et al. (2016) to measure the perception of traumatic birth in women (18-40 years old) consists of 13 questions and one sub-dimension. The cronbach alpha value of the scale was found to be 0.89. Each question is scored between 0-10 from none to the most severe. As the score obtained from the scale increases, the level of perception of birth as traumatic increases.
Baseline (It will be applied before starting the intervention)
Fear of Childbirth Scale for Pregnant Women and Their Partners
Time Frame: Baseline (It will be applied before starting the intervention)
The Fear of Birth Scale (FOBS) was developed by Haines et al. in 2011 to measure fear of childbirth. Psychometric analyses in Turkish culture were conducted by Serçekuş Ak, Vardar, & Özkan (2018) and it was determined that the scale is a valid and reliable measurement tool that can be used to determine fear of childbirth on pregnant women and their partners in Turkish society. In the Turkish validity and reliability study of the scale, the cronbach alpha internal consistency coefficient was found to be 0.93.
Baseline (It will be applied before starting the intervention)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Preparation for Labor and Birth (P-LAB) Instrument
Time Frame: through study completion, an average of one week.
The Preparation for Labor and Birth (P-LAB) Instrument was developed by Neerland and colleagues (Neerland et al., 2020). It was conducted to determine the confidence of pregnant women in their physiological ability to give birth. The scale is 5-point Likert type and consists of 22 items. The scale consists of four sub-dimensions. The Turkish validity and reliability study of the scale was conducted by Uludağ and Uçtu (2022). Cronbach's alpha value is above 0.70 for all scales and subscales.
through study completion, an average of one week.
Traumatic Birth Perception Scale
Time Frame: through study completion, an average of one week.
The scale developed by Yalnız et al. (2016) to measure the perception of traumatic birth in women (18-40 years old) consists of 13 questions and one sub-dimension. The cronbach alpha value of the scale was found to be 0.89. Each question is scored between 0-10 from none to the most severe. As the score obtained from the scale increases, the level of perception of birth as traumatic increases.
through study completion, an average of one week.
Fear of Childbirth Scale for Pregnant Women and Their Partners
Time Frame: through study completion, an average of one week.
The Fear of Birth Scale (FOBS) was developed by Haines et al. in 2011 to measure fear of childbirth. Psychometric analyses in Turkish culture were conducted by Serçekuş Ak, Vardar, & Özkan (2018) and it was determined that the scale is a valid and reliable measurement tool that can be used to determine fear of childbirth on pregnant women and their partners in Turkish society. In the Turkish validity and reliability study of the scale, the cronbach alpha internal consistency coefficient was found to be 0.93.
through study completion, an average of one week.

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.
Pamukkale University

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.
January 25, 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.
February 8, 2024

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.
February 29, 2024

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).
December 18, 2023

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.
January 8, 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.
January 9, 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.
January 9, 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.
January 8, 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.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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-60116787-020-462207

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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