- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06849440
Effectiveness of Childbirth Preparation Education
August 20, 2025 updated by: Antalya Bilim University
The Effect of Childbirth Preparation Education on Perceived Stress and Traumatic Birth Perception in Pregnant Women
The act of birth, which is considered a natural event, is an act that the mother will remember with positive experiences in her life if it progresses normally.
However, sometimes birth can be perceived as stressful and traumatic for women.
Stress during pregnancy is a problem that should be emphasized and managed due to its negative effects on the health of the mother and the baby.
As the pregnancy progresses, the levels of stress hormones may increase.
In addition, the thought of spontaneous birth exposes women to physical discomfort, stress and uncertainty during pregnancy.
The perception of traumatic birth is an important concept that emerges as a result of the woman's mental birth scenario, the information she has acquired about birth, and every situation she experiences during the birth, and also affects the postpartum period.
In studies conducted in Turkey using the Traumatic Birth Perception Scale, it was determined that 23.6% and 26.9% of women experienced a high level of traumatic birth perception.
Nulliparity, negative feelings about birth, inadequate antenatal care, inadequate psychosocial support, risky pregnancies, and lack of information about birth are among the factors that may cause traumatic birth perception.
Physical and mental preparation for birth and information about pain management are considered to be the basic elements of prenatal education classes.
There are study results indicating that birth preparation classes benefit women in many aspects such as self-sufficiency, reduced fear of birth, and positive pregnancy experience.
No study results have been found in the literature examining the effect of birth preparation education on the perception of traumatic birth during pregnancy.
Based on this, this study was needed to examine the effect of pregnant women's participation in childbirth preparation training on their perceived stress level and perception of traumatic birth.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
38
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 Locations
-
-
-
Antalya, Turkey (Türkiye)
- Antalya Bilim 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
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
28-34th weeks of pregnancy Agree to participate in the study Be literate Be able to speak and understand Turkish
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Training group
The sociodemographic data collection form and the perceived stress and traumatic birth perception scales as pre-tests will be applied to the pregnant women who accept the study before the childbirth training.
After the pre-test, the pregnant women will be given face-to-face childbirth preparation training in a classroom environment during four sessions.
When the participants complete the training sessions, the scales will be applied as a post-test.
The data collection process will be completed after the application of the scales.
|
Participants will be divided into groups of ten and the training is planned in 4 sessions.
Session contents are prepared as sharing general information on preparation for birth, explanation of frequently applied interventions in labor, explanation of non-drug pain relieving methods, teaching and practicing active birth positions that help the labor progress.
The duration of the sessions is planned as 2 hours on average.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Stress Scale (PSS)
Time Frame: Pre-test and immediately post-test
|
It was developed by Cohen et al. (1983).
The scale was adapted to Turkish by Eskin et al. (2013).
The PSS, which consists of 14 items in total, was designed to measure the degree to which a number of situations in a person's life are perceived as stressful.
Participants evaluate each item on a 5-point Likert-type scale ranging from "Never (0)" to "Very often (4)".
7 of the items containing positive expressions are scored reversely.
Scores vary between 0 and 56.
A high score indicates a high perception of stress.
In the study by Eskin et al., the Cronbach's alpha value of the scale was found to be 0.84.
|
Pre-test and immediately post-test
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Traumatic Birth Perception Scale (TBPS)
Time Frame: Pre-test and immediately post-test
|
The Traumatic Birth Perception Scale (TBPS) was developed by Yalnız et al. (2016) to determine the perception of traumatic birth, and its validity and reliability studies were conducted.
The original study was conducted on women aged 18-40.
The final version of the scale consists of 13 items.
Each item is in the form of an ordinal scale and is scored between 1 (lowest score) and 10 (highest score).
The scores obtained from each item are added together.
As the score obtained from the scale increases, it shows that the level of perception of birth as traumatic increases.
The score obtained from the scale varies between 0 and 130.
According to the total score of the scale; 0-26 points indicate "very low", 27-52 points indicate "low", 53-78 points indicate "medium", 79-104 points indicate "high", and 105-130 points indicate "very high" level of perception of traumatic birth.
The Cronbach alpha value was found to be 0.89 in the original study of the scale.
|
Pre-test and immediately post-test
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
March 1, 2025
Primary Completion (Actual)
May 9, 2025
Study Completion (Actual)
May 9, 2025
Study Registration Dates
First Submitted
January 14, 2025
First Submitted That Met QC Criteria
February 25, 2025
First Posted (Actual)
February 27, 2025
Study Record Updates
Last Update Posted (Estimated)
August 27, 2025
Last Update Submitted That Met QC Criteria
August 20, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-101
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.
Clinical Trials on Perceived Stress
-
Istanbul Kent UniversityCompletedStress | Psychological | Perceived StressTurkey (Türkiye)
-
Mibelle AGCompleted
-
Vilnius UniversityLinkoeping UniversityCompleted
-
Pusan National University Yangsan HospitalCompletedPerceived StressKorea, Republic of
-
Ain Shams UniversityRecruitingPerceived StressEgypt
-
United States Naval Medical Center, San DiegoUniversity of California, San Francisco; TriService Nursing Research ProgramCompletedPerceived StressUnited States
-
Idaho State UniversityCompletedMusculoskeletal Disorders | Perceived Stress | Stress Management | Reported Stress | Perceived Pain | Reported PainUnited States
-
Radboud University Medical CenterWageningen University and Research; Movisie; Municipality of Meppel, the Netherlands and other collaboratorsCompletedPerceived Stress | Persistent PovertyNetherlands
-
Kutahya Health Sciences UniversityCompletedPsychological Resilience | Perceived Stress | Stress Management | Coping StrategyTurkey
-
The Cleveland ClinicGeneral ElectricCompletedHealthy Individuals With Perceived StressUnited States
Clinical Trials on Training
-
Northeastern UniversityOregon Health and Science University; University of California, RiversideRecruiting
-
University of Trás-os-Montes and Alto DouroCompletedLipid Metabolism Disorders | Sarcopenia | Osteoporosis | Overweight and Obesity | Personal Satisfaction | Hypertension With Complications and Secondary HypertensionPortugal
-
New Jersey Institute of TechnologyRutgers, The State University of New JerseyCompletedHemiplegia | Hemiparesis | Cerebrovascular AccidentUnited States
-
University of Sao PauloFundação de Amparo à Pesquisa do Estado de São PauloCompletedHypertension | Diabetes | Peripheral Arterial DiseaseBrazil
-
Foundation for Atlanta Veterans Education and Research...United States Department of Defense; NYU Langone Health; University of Rochester and other collaboratorsRecruitingStress Disorders, Post-TraumaticUnited States
-
Lebanese UniversityCompletedHeart Failure | Quality of Life | Cardiac Rehabilitation | Aerobic Exercise | Exercise Intolerance | Respiratory Muscle Training | Strength Training
-
Recep Tayyip Erdogan UniversityThe Scientific and Technological Research Council of TurkeyCompletedAthletic PerformanceTurkey (Türkiye)
-
University of PittsburghEunice Kennedy Shriver National Institute of Child Health and Human Development...Completed
-
Ralf RothEnrolling by invitationFocus on Healthy InfantsSwitzerland