The Effect Of Sitting Position On The Labor Process (POSİTİON)

August 5, 2024 updated by: Hilal Guveri, Cumhuriyet University
This study was conducted to determine the effect of sitting position on the labor process. The randomized controlled experimental study was conducted in the delivery room of Sivas Numune Hospital.

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.

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.
160

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, 58000
        • Cumhuriyet Universitesi
    • Sivas Merkez
      • Sivas, Sivas Merkez, Turkey, 58000
        • Hilal Güveri

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

  1. Inclusion Criteria:

    • Age range: 19-35
    • 38-42 weeks of pregnancy
    • No health problems that would prevent the use of sitting position
    • -Amniotic membranes not ruptured
    • Having a singleton pregnancy
    • Fetus in vertex position
    • Labor occurs with normal spontaneous vaginal delivery
    • No diagnosed chronic physical disease
    • No diagnosed psychiatric disease
    • No risky pregnancy, risky delivery and newborn/fetus
    • No communication problems
    • Voluntarily participating in the research

  2. Exclusion Criteria:

    • Only women who gave birth at Sivas Sample Hospital were included in the study
    • Women who gave birth more than two times were not included in the study

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: Single

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: Arm 1:Vertical Position (Experimental Group-Primiparous)
All pregnant women in the experimental group were allowed to use a sitting position (sitting and rocking on a pilates ball or sitting on a bed) from the active phase until labor. They were allowed to lie down for 10-15 minutes when they were tired or when monitoring or intervention was needed.
Behavioral: Sitting position is used in Experimental Arms 1-2
sitting position Comparison of sitting position and lithotomy position in labor
Other Names:
  • Lithotomy position is used in those with Active Comparison Arm 3-4.
Experimental: Arm 2: Vertical Position (Experimental Group-Multiparous)
All pregnant women in the experimental group were allowed to use a sitting position (sitting and rocking on a pilates ball or sitting on a bed) from the active phase until labor. They were allowed to lie down for 10-15 minutes when they were tired or when monitoring or intervention was needed.
Behavioral: Sitting position is used in Experimental Arms 1-2
sitting position Comparison of sitting position and lithotomy position in labor
Other Names:
  • Lithotomy position is used in those with Active Comparison Arm 3-4.
Active Comparator: Arm 3: Lithotomy Position (Control Group-Primiparous)
All pregnant women in the control group were followed up with hospital procedures during labor. From the latent phase until labor, the pregnant woman was followed up with hospital procedures. At the end of the latent and active phases, pain assessment was requested and VAS (Appendix 6) was applied. The 2nd and 3rd stages of labor were performed on a normal delivery table in the lithotomy position.
Behavioral: Sitting position is used in Experimental Arms 1-2
sitting position Comparison of sitting position and lithotomy position in labor
Other Names:
  • Lithotomy position is used in those with Active Comparison Arm 3-4.
Active Comparator: Arm 4: Lithotomy Position (Control Group-multiparous)
The hospital procedure was applied to determine the birth rates of all pregnant women in the control group. From the latent stage until the birth, the pregnant woman is followed up by applying the hospital procedure. At the end of the latent and active phases, the alarm results were requested to be evaluated and VAS (Appendix 6) was developed. The 2nd and 3rd stages of labor were performed in the lithotomy positions on the normal delivery table.
Behavioral: Sitting position is used in Experimental Arms 1-2
sitting position Comparison of sitting position and lithotomy position in labor
Other Names:
  • Lithotomy position is used in those with Active Comparison Arm 3-4.

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
Visual analog scale is applied starting from the 1st stage of labor and until the end of the 2nd stage.If the VAS value is 10, it means there is a lot of pain, and if it is 0, it means there is no pain.
Time Frame: 1 years
The effect of sitting positions of pregnant women in the 38-42nd weeks of pregnancy on the birth process
1 years

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

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.
May 2, 2022

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.
November 2, 2022

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.
April 4, 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).
July 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.
August 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.
August 5, 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.
August 7, 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.
August 5, 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.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • 2022-04/01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Yes: There is a plan to make IPD and related data dictionaries available.

IPD Sharing Time Frame

1 years

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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