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

Primary Purpose

Continuous Birth Support

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
uninterrupted accompanying support
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Continuous Birth Support focused on measuring continuous birth support, birth time, labor pain, satisfaction

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Istanbul Universty CerrahpaşaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

experimental group

control group

Arm Description

The experimental group will be provided with routine midwife support and uninterrupted accompanying support.

Only routine midwife support will be provided to the control group.

Outcomes

Primary Outcome Measures

Visual Analog Scale (VAS)
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.
Personal information form
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.

Secondary Outcome Measures

Full Information

First Posted
January 23, 2023
Last Updated
January 31, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05720962
Brief Title
The Effect of Continuous Accompanying Support in the Active Phase on Labor Pain, Duration and Satisfaction
Official Title
The Effect of Continuous Accompanying Support in the Active Phase on Labor Pain, Duration and Satisfaction
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study was planned to determine the effect of continuous accompanying support during the active phase on labor pain, duration and satisfaction.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Continuous Birth Support
Keywords
continuous birth support, birth time, labor pain, satisfaction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled study with two groups as control and experimental group
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
The experimental group will be provided with routine midwife support and uninterrupted accompanying support.
Arm Title
control group
Arm Type
No Intervention
Arm Description
Only routine midwife support will be provided to the control group.
Intervention Type
Procedure
Intervention Name(s)
uninterrupted accompanying support
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
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.
Time Frame
"through study completion, an average of 1 year"
Title
Personal information form
Description
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.
Time Frame
"through study completion, an average of 1 year".

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dilan Cömert
Phone
+90 545 490 28 00
Email
dilancmrtt@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dilan Cömert
Organizational Affiliation
Msc Midwife
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Universty Cerrahpaşa
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tülay Yılmaz
Phone
+90 533 374 02 08
Email
tyilmaz@iuc.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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