The Effect of Continuous Accompanying Support in the Active Phase on Labor Pain, Duration and Satisfaction

March 4, 2024 updated by: dilan cömert, Istanbul University - Cerrahpasa (IUC)
This study was planned to determine the effect of continuous accompanying support during the active phase on labor pain, duration and satisfaction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants who comes into childbirth needs the support of people around her in order to cope with the stress, anxiety and labor pain she experiences. This support is the continuous birth support given from the time the participants comes to the hospital until the birth of the baby. Having someone who supports the woman during the birth process will provide a positive birth experience for pregnant women. At the same time, the feeling of pain of the supported woman will be reduced and the delivery time will be shortened.

This randomized controlled study was planned to be performed on primiparous pregnant women between January 2023 and January 2024. The data of the study will be collected with "Personal Information Form", "Visual Analog Scale".

The study was divided into two groups as experimental and control groups. 55 participants in the experiment -55 participants will be randomized to the control group. Participants meeting the inclusion criteria will be asked to rate their pain and satisfaction from 0 to 10 with the VAS 4 cm, 6 cm, 8 cm and fully open. While both groups receive routine midwife support, when the experimental group reaches 4 cm, a person they want will be taken with them and continuous support will be given until there is a dilation of 10 cm.

Study Type

Interventional

Enrollment (Actual)

110

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 Contact

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Istanbul Universty Cerrahpaşa

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

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18-35 years old
  • Being literate
  • Fluent and speaking Turkish
  • Primiparous
  • Spontaneous vaginal delivery planned
  • At the beginning of the active phase (dilatation 4 cm)
  • Pregnant women who agreed to participate in the research

Exclusion Criteria:

  • Presence of a health problem in the mother during pregnancy
  • At risk of fetal anomaly
  • Having multiple pregnancy
  • Administering analgesic medication during labor

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
The experimental group will be provided with routine midwife support and uninterrupted accompanying support.
Procedure: uninterrupted accompanying support

When the participants in the experimental group are taken to the delivery unit, when the neck dilation is 4 cm, a person they want will be taken with them to support them.

Afterwards, the pain status and satisfaction of the participants will be questioned when it is 4 cm, 6 cm, 8 cm and 10 cm.
No Intervention: control group
Only routine midwife support will be provided to the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS)
Time Frame: "through study completion, an average of 1 year"
It is a reliable and easily applicable scale accepted in the world literature. It is used to measure the values that cannot be measured numerically in the evaluation of the pain intensity and satisfaction of the patients. A minimum of 0 and a maximum of 10 points can be obtained from the scale. Additionally, higher scores indicate higher pain intensity, higher satisfaction.
"through study completion, an average of 1 year"
Personal information form
Time Frame: "through study completion, an average of 1 year".
It is a form that includes questions that determine socio-demographic characteristics and perception of support. The form also includes questions about the process of the birth period.
"through study completion, an average of 1 year".

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Investigators

  • Principal Investigator: Dilan Cömert, Msc Midwife

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)

January 1, 2023

Primary Completion (Actual)

January 1, 2024

Study Completion (Actual)

March 1, 2024

Study Registration Dates

First Submitted

January 23, 2023

First Submitted That Met QC Criteria

January 31, 2023

First Posted (Actual)

February 9, 2023

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/401

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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