Emotional Support Given at Birth to Women Effect on Birth Duration, Perception and Fear

June 24, 2024 updated by: Sukran Ertekin Pinar, Cumhuriyet University

Introduction: Women begin to experience fear long before birth, and the reason for their fear may be related to their baby, themselves, their partner/relatives, and the healthcare professional. Fear can disrupt the natural process of birth, prolong the stages of birth and cause postpartum complications.The research was conducted to determine the effect of emotional support given during birth on the woman's birth duration, perception and fear.

Methods:The population of the randomized controlled experimental study consisted of nulliparous women who applied for normal spontaneous birth to the Birth Unit of a State Hospital in the Central Anatolia Region of Turkey (40 experimental subjects, 40 control subjects).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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

Introduction: Women begin to experience fear long before birth, and the reason for their fear may be related to their baby, themselves, their partner/relatives, and the healthcare professional. Fear can disrupt the natural process of birth, prolong the stages of birth and cause postpartum complications.Minimizing the fears experienced during birth can lead to more successful and comfortable births, a complication-free birth and less pain for both the woman and the baby.Therefore, emotional support from healthcare professionals is important.

Aim: The research was conducted to determine the effect of emotional support given during birth on the woman's birth duration, perception and fear.

Methods:The population of the randomized controlled experimental study consisted of nulliparous women who applied for normal spontaneous birth to the Birth Unit of a State Hospital in the Central Anatolia Region of Turkey (40 experimental subjects, 40 control subjects).While emotional support practices and standard care were applied to women in the experimental group, only standard care practices were applied to women in the control group. Data were collected using the Personal Information Form, Wijma Birth Expectation/Experience Scale (W-DEQ) Version A, Wijma Birth Expectation/Experience Scale (W-DEQ) Version B, and Women's Perceptions of Supportive Care Provided at Birth Scale.The forms were applied twice to women applying for birth: during labor (first follow-up) and the second follow-up within 2-4 hours after birth. Number and percentage distribution, chi-square test, t test in independent groups, Mann-Whitney U test, Wilcoxon test, and Cohen d test were used in the evaluation of the data.

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 (Actual)

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
      • Sivas, Turkey, 58140
        • Sukran Ertekin Pinar

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:

  • Nulliparous,
  • Between the ages of 18-35,
  • Admitted to the delivery room for normal spontaneous vaginal birth,
  • Do not have any physical health problems for themselves or their baby,
  • Does not have a diagnosed mental illness,
  • Not having a risky pregnancy,
  • Able to speak and read Turkish,
  • Cervical dilatation of 4 cm or more,
  • Women who were willing to participate in the study were included in the study.

Exclusion Criteria:

-Multiparity

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: Standard of care Group
The control group did not receive any treatment.
Experimental: Emotional support group
Empathetic approach, listening to the feelings and thoughts, welcoming the woman's behavior and expressions, telling her that she is breathing correctly, etc.), not judging the woman, being honest, using a soft and calm tone of voice, taking the baby or asking her opinion, encouraging her to endure the birth process, touching the woman and making physical contact, allowing her to practice her beliefs, showing the baby to the mother as soon as it is born and placing it in her arms.
Behavioral: Emotional support
Emotional support helps the woman giving birth effectively, meets her emotional needs and expectations, ensures her comfort, improves birth outcomes, increases her self-esteem, ensures a positive birth experience and facilitates her transition into the role of motherhood.
Other Names:
  • Control Group

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 Delivery Expectancy/Experience Questionnaire version A (W-DEQ-A)
Time Frame: Baseline
The W-DEQ-A is a validated, to determine the level of birth fear experienced by pregnant women.Answers in the scale are numbered from 0 to 5 and are in a six-point Likert type. The minimum score that can be obtained from the scale is 0, and the maximum score is 165.
Baseline
Women's Perceptions Scale on Supportive Care Provided at Birth
Time Frame: Baseline
The scale, which consists of 33 items, has three sub-dimensions: "comforting, informing and disturbing behaviors". Answers in the scale are numbered from 1 to 4 and are in a four-point Likert type. The minimum score that can be obtained from the scale is 33, and the maximum score is 132.
Baseline

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
Wijma Birth Expectation/Experience Scale (W-DEQ) Version B
Time Frame: Within 2-4 hours after birth
W-DEQ-B was developed to evaluate women's fear of birth during their own birth experiences in the postpartum period. Responses on the scale are numbered from 1 to 6 and are in a six-point Likert type. The minimum score that can be obtained from the scale is 33 and the maximum score is 198.
Within 2-4 hours after birth
Women's Perceptions Scale on Supportive Care Provided at Birth
Time Frame: Within 2-4 hours after birth
The scale, which consists of 33 items, has three sub-dimensions: "comforting, informing and disturbing behaviors". Answers in the scale are numbered from 1 to 4 and are in a four-point Likert type. The minimum score that can be obtained from the scale is 33, and the maximum score is 132.
Within 2-4 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.
Cumhuriyet University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sukran Ertekin Pinar, Cumhuriyet 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.
July 1, 2020

Primary Completion (Actual)

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.
December 30, 2020

Study Completion (Actual)

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 30, 2020

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).
June 24, 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.
June 24, 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.
June 28, 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.
June 28, 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.
June 24, 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.
June 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.
  • TR SİVAS 05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available.

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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