The Effect of Ideal Birth Environment on Birth Pain, Fear of Childbirth, Mode of Delivery and Duration of Delivery

December 20, 2024 updated by: Sema Göçmez, Mehmet Akif Ersoy University

The aim of this study was to investigate whether the ideal birth environment is related to fear of childbirth, labor pain, duration of labor, and mode of delivery.

on the impact of the study. The main questions it aims to answer are Does the ideal birth environment reduce fear of childbirth? Does the ideal birth environment reduce labor pain? does the ideal birth environment affect the duration of labor? In order to evaluate the effect of the ideal birth environment on fear, pain and duration of labor, the researchers will compare the standard delivery room and women who will give birth in a room customized for women, where they have their own sheets, pillows, items that make them feel special, where medical devices are reduced, in a room where they have photos with their partner, in a room where they listen to the music they want, where they have freedom of movement. both in the experimental and control groups: In the last trimester, the Wijma birth experience A version will be applied and in the postpartum period, the Wijma B Birth experience scale will be applied again and the fear of childbirth will be evaluated. Pain in labor will also be assessed using VAS (Visceral Visual Analgesic Scale) during the latent and active phase of labor.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

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

The birth environment filled with medical instruments increases the level of anxiety and fear in the mother.

increase, disrupting the neurohormonal relationship that ensures the normal functioning of labor and an increase in the rate of cesarean section deliveries. Also women when she does not feel safe in her environment and her baby does not feel safe, the birth process is temporary. may slow down as a result release of adrenaline (epinephrine) and noradrenaline (norepinephrine) as a result of stress and anxiety increases, creating a "fight or flight" situation in the woman. Adrenaline and noradrenaline are the main

towards the end of labor to help the fetus to expel, while towards the end of labor should be at a low level at the beginning. The woman cannot fight stress in these cases, adrenaline and noradrenaline levels increase, while oxytocin levels decrease. This one from a physiological point of view, it can cause the progression of labor to stop, the duration prolonged labor and increased cesarean section rates. In a study conducted with pregnant rats, noise and movement in the birth environment restriction has been found to negatively affect hormones involved in labor

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.
80

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 Locations

  • Turkey
    • Bucak
      • Burdur, Bucak, Turkey, 15300
        • Mehmet Akif Ersoy Üniversitesi

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:

18-35 years old pregnant primiparous literate

Exclusion Criteria:

Medium and high-risk pregnant women (oligohydramnios, pre-eclampsia, heart disease, diabetes, placenta previa)

  • Psychiatric illness such as anxiety and depression
  • Communication barrier

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: None (Open Label)

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: control group
will receive standard care, no intervention will be performed
Active Comparator: ideal birth environment

ideal birth room While designing a single room without unnecessary medical equipment, your own bed linen, bed linen, It will be a pillow case, a photo frame, he will be able to listen to the music he wants, he will be able to make a photo of his own choice.

There will be a companion, a birthing ball and chair, and the room will allow freedom of movement.

It will be designed to allow
Behavioral: ideal birth environment

ideal birth room While designing a single room without unnecessary medical equipment, your own bed linen, bed linen, It will be a pillow case, a photo frame, he will be able to listen to the music he wants, he will be able to make a photo of his own choice.

There will be a companion, a birthing ball and chair, and the room will allow freedom of movement.

It will be designed to allow

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
Wijma Birth Expectancy/Expectation Questionnaire (W-DEQ) A Version
Time Frame: 28-36 weeks of gestation

Wijma Birth Expectancy/Expectation Scale A Version (W-DEQ A), W-DEQ consists of 33 items and is a six-point Likert-type scale.

Item responses are numbered from 0 to 5, with 0 indicating "completely" and 5 indicating "not at all".

is expressed. The minimum score is 0 and the maximum score is 165. The cut-off value is 85 points and a score of 85 and above is expressed as clinical fear.

is also analyzed. The higher the total score of the scale, the higher the degree of fear experienced.

is high.

  • W-DEQ score? 37 mild,
  • W-DEQ score = 38-65 moderate,
  • W-DEQ score = 66-84 in severe degree,
  • A W-DEQ score of ? 85 indicates a clinical degree of fear. Scale 2, Questions 3, 6, 7, 8, 11, 12, 15, 19, 20, 24, 25, 27 and 31 are negatively loaded and there is no agreement in the measurement.

The alpha value of the scale is calculated by inverting the scale in the opposite direction. Cronbach's alpha value of the scale 0.89 (Korukcu et al., 2012) Wijma Birth Anticipation/Experience Sc
28-36 weeks of gestation
VASA Pain Assessment Scale
Time Frame: during the latent phase of labor when the cervical opening is 1-3 cm and during the active phase of labor when the cervical opening is 5-7 cm
Quantitative pain rating scale (QPRS) is used to assess the severity of pain. is used. On a numerical rating scale, pain ranges from 0 (no pain) to 10 (unbearable pain) score (Price et al., 1983).
during the latent phase of labor when the cervical opening is 1-3 cm and during the active phase of labor when the cervical opening is 5-7 cm
WIJMA BIRTH EXPECTANCY/EXPERIENCE SCALE B VERSION
Time Frame: up to the first 12 hours after birth

he W-DEQ consists of 33 items and is a six-point Likert-type questionnaire. Item responses are numbered from 0 to 5, with 0 indicating "completely" and 5 indicating "not at all".

is expressed. The minimum score is 0 and the maximum score is 165. The cut-off value is 85 points and a score of 85 and above is expressed as clinical fear.

is also analyzed. The higher the total score of the scale, the higher the degree of fear experienced.

is high.

  • W-DEQ score? 37 mild,
  • W-DEQ score = 38-65 moderate,
  • W-DEQ score = 66-84 in severe degree,
  • A W-DEQ score of ? 85 indicates a clinical degree of fear. Scale 2, Questions 3, 6, 7, 8, 11, 12, 15, 19, 20, 24, 25, 27 and 31 are negatively loaded and there is no agreement in the measurement.

is calculated by inverting it in the opposite direction in order to provide

Translated with www.DeepL.com/Translator (free version)
up to the first 12 hours after birth

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.
Mehmet Akif Ersoy 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 (Actual)

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.
October 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.
April 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.
July 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).
December 10, 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.
December 20, 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.
March 25, 2025

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.
March 25, 2025

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.
December 20, 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.
December 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.
  • GO 2024/510

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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