Companions Who Support the Pregnant Woman During the Birth Process (SupportBirth)

October 2, 2024 updated by: Bihter Akın, Selcuk University

Evaluation of the Opinions of Companions Who Support the Pregnant Woman During the Birth Process: Mixed Method Study

In our country, although there is currently an emphasis on companion support within the scope of mother-friendly hospitals, there is no guide for companions. This study was planned to determine the effect of women who have companion support during labor on birth satisfaction, birth comfort, postpartum comfort level and positive birth outcomes, as well as the opinions of the people who provide support. Based on the results obtained and the positive contributions to maternal satisfaction during the labor process, birth and postpartum comfort process, mother-baby health, as well as the opinions of the companions, a 'Pregnant Support Guide in Labor' will be created and the companions will be enabled to support the pregnant woman in line with this guide. In addition, based on the opinions of the attendants, the researchers plan to develop the 'Birth Support Satisfaction Scale'.

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

Type of research The study is a Randomized Controlled Mixed Method study. Research Design This study is a mixed method study planned to be conducted to evaluate the effect of companion support on the labor process and the opinions of companions, using a randomized controlled experimental design and in-depth individual interview method. This clinical trial will be registered at ClinicalTrials.gov. Reporting will be adhered to CONSORT for parallel group randomized studies. (CONSORT 2010, Access date: 10 August 2022). The research is planned to be carried out in the delivery room of Sakarya Training and Research Hospital between 01 March 2023 and 30 December 2024.

Where the Research Will Be Conducted The study will be carried out in the delivery room of Sakarya Training and Research Hospital. Pregnant women who have started labor are admitted to the delivery room by a doctor, and labor follow-up is carried out by midwives and assistant doctors under the supervision of a gynecologist. On average, around 350 vaginal births occur monthly. Since the hospital is not mother-friendly, a companion is not allowed to accompany the pregnant woman in routine practices.

Data Collection Stages The intervention and control groups will be informed about the research, and a personal information form will be applied to pregnant women and their companions who accept it.

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.
100

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
      • Konya, Turkey, 42100
        • Selcuk University
    • Konya
      • Selçuklu, Konya, Turkey, 42060
        • Bihter Akın

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:

  • Pregnant women aged 37-42.
  • Women who are planning to give birth vaginally during their first week of pregnancy.
  • First-time pregnant women.
  • Women with no vision, hearing, or communication problems.
  • Women who can speak and express themselves in Turkish.
  • Women who are willing to participate voluntarily in the study.

Exclusion Criteria:

  • Pregnant women with multiple pregnancies.
  • Women who are planned to give birth by cesarean section.
  • Women with any complications during pregnancy.
  • Women with chronic diseases.
  • Pregnant women with verbal, mental, or other communication disabilities.
  • Among the pregnant women included in the control or intervention group, those who:
  • Received epidural analgesia.
  • Experienced instrumental delivery (with vacuum or forceps).
  • Had postnatal complications in the newborn.
  • Had complications related to episiotomy (such as 3rd and 4th degree laceration, hematoma).

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: Triple

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: emotional and physical support to the pregnant woman provided by attendant
Following the information, the attendant will provide emotional and physical support to the pregnant woman (such as massage, supporting the pregnant woman while moving, giving the pregnant woman a warm shower), and all interventions made by the companion and their duration will be recorded by the researcher in the 'Birth Process Support Form'. When the cervical dilatation is 8 cm, the Birth Comfort Scale will be applied to the pregnant woman, and two hours after the birth, the Birth Satisfaction Scale and the Postpartum Comfort Scale will be applied. Information about the birth process will be recorded in the Birth Information Form. In addition, semi-structured questions in the 'Companion Interview Form' will be asked to the companions selected for qualitative interviews and voice recording will be recorded.
Behavioral: emotional and physical support to the pregnant woman provided by attendant
The companion will provide emotional and physical support to the pregnant woman (such as massage, supporting the pregnant woman while moving, taking a warm shower, etc.), and all interventions made by the companion and their duration will be recorded by the researcher in the 'Birth Process Support Form'. When the cervical dilatation is 8 cm, the Birth Comfort Scale will be applied to the pregnant woman, and two hours after the birth, the Birth Satisfaction Scale and the Postpartum Comfort Scale will be applied. Information about the birth process will be recorded in the Birth Information Form. In addition, semi-structured questions in the 'Companion Interview Form' will be asked to the companions selected for qualitative interviews and voice recording will be recorded.
No Intervention: Standard of care
Women who are informed about the purpose and practices of the research and who agree to participate in the study voluntarily will not be deviated from routine practices in the hospital. Women who are followed and delivered by the same midwife will be included in the study to ensure that there is no difference between the groups in terms of episiotomy application and birth techniques. When the cervical dilatation is 8 cm, the Birth Comfort Scale will be applied to the pregnant woman, and two hours after the birth, the Birth Satisfaction Scale and the Postpartum Comfort Scale will be applied. Information about the birth process will be recorded in the Birth Information Form.

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
Birth Comfort Scale Score
Time Frame: At the time of cervical dilatation reaching 8 cm during the intrapartum period

The Birth Comfort Scale is a tool designed to evaluate the level of comfort experienced by women during labor and delivery. The scale measures the influence of physical, psychological, and environmental factors on comfort during childbirth. It allows women to assess aspects such as physical ease, pain management, a sense of security, and environmental support during labor. Typically, the scale follows a 5-point Likert format, with each item scored from 1 to 5 (1: Strongly disagree, 5: Strongly agree). The total comfort score can range from a minimum of 10 to a maximum of 50.

The scale demonstrates high internal consistency as measured by Cronbach's Alpha, with values typically ranging between 0.80 and 0.90, indicating that it is a reliable tool for assessing birth comfort.
At the time of cervical dilatation reaching 8 cm during the intrapartum period

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
Postpartum Comfort Scale
Time Frame: Two hours postpartum

The Postpartum Comfort Scale is designed to assess the comfort levels of women during the postpartum period. The scale evaluates comfort in three key areas: physical, psychological, and socio-cultural. It measures factors such as physical discomforts, emotional state, social support, and environmental influences during the postnatal period. The scale is typically structured as a 5-point Likert scale, with each item scored from 1 to 5 (1: Strongly disagree, 5: Strongly agree). The total score indicates whether the woman's postpartum comfort is low or high.

The scale's Cronbach's Alpha is typically reported to be 0.85 or higher, indicating high reliability. This tool helps healthcare professionals better understand and address the needs of women during the postpartum period, leading to more effective interventions.
Two hours postpartum

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.
Selcuk 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.
  • Study Chair: Bihter Akın, Selcuk 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.
March 1, 2023

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.
September 1, 2024

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.
September 1, 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).
February 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.
October 2, 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.
October 3, 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.
October 3, 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.
October 2, 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.
October 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.
  • 2023/1021

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

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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