The Effect of Wireless Electronic Fetal Monitoring on Labor Pain and Birth Experiences

NCT ID: NCT07233187

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-15

Study Completion Date

2026-01-15

Brief Summary

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This study is using Electronic Fetal Monitoring (EFM) to assess fetal health in pregnant women in labor. This will be compared with continuous wired EFM and continuous wireless EFM. The effects of wireless and continuous wireless EFM on labor pain levels and labor experiences will be measured.

Detailed Description

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In this study, Electronic Fetal Monitoring (EFM) is being applied to pregnant women in labor to assess fetal health. This procedure is typically performed in hospitals using a continuous wired EFM. During this period, women are forced to lie down constantly and cannot use active methods to cope with pain. Therefore, using a wireless EFM may be an approach that allows for continuous assessment while also supporting women's activity. Therefore, a comparison will be made between continuous wired EFM and continuous wireless EFM. During labor, pain levels will be assessed using the Visual Analog Scale when cervical dilation is between 8 and 10 cm. After the first hour postpartum, the labor experience of the postpartum woman will be collected using the Birth Experiences Scale.

Conditions

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Birth Intrapartum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Continuous Wired EFM Group

In routine practice, fetal health assessments for pregnant women presenting for labor are conducted using a continuous wired EFM. Pregnant women in this group will not receive any interventions other than routine procedures. Because pregnant women are constantly connected to the EFM, the EFM will be removed and reconnected when necessary, such as when going to the toilet.

Group Type NO_INTERVENTION

No interventions assigned to this group

Continuous Wireless EFM Group

Pregnant women in this group will be continuously assessed with wireless EFM. Because it's a wireless application, pregnant women will have the freedom to move freely throughout labor. They will be able to perform their own activities, such as toileting, and other necessary activities. Pregnant women will not be subjected to any other procedures other than continuous wireless EFM.

Group Type EXPERIMENTAL

Continuous Wireless EFM Group

Intervention Type OTHER

Pregnant women in this group will be continuously assessed with wireless EFM. Because it's a wireless application, pregnant women will have the freedom to move freely throughout labor. They will be able to perform their own activities, such as toileting, and other necessary activities. Pregnant women will not be subjected to any other procedures other than continuous wireless EFM.

Interventions

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Continuous Wireless EFM Group

Pregnant women in this group will be continuously assessed with wireless EFM. Because it's a wireless application, pregnant women will have the freedom to move freely throughout labor. They will be able to perform their own activities, such as toileting, and other necessary activities. Pregnant women will not be subjected to any other procedures other than continuous wireless EFM.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* The study included healthy primiparous or multiparous pregnant women who agreed to participate in the study, were between the ages of 18 and 35, had a gestational age greater than 37+0, had cervical dilation greater than 4 cm, had a single, live fetus, were not using uterotonic agents, spoke Turkish, had no comprehension, perception, or communication problems, and were healthy.

Exclusion Criteria

* Pregnant women who were diagnosed with a risky pregnancy, who were illiterate, who had a contagious disease, or who had a risky disease were not included in the study.
Minimum Eligible Age

19 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Tokat Gaziosmanpasa University

OTHER

Sponsor Role lead

Responsible Party

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Melek Şen Aytekin

Research Assistant Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Melek Şen Aytekin, Research Assistant

Role: PRINCIPAL_INVESTIGATOR

Tokat Gaziosmanpasa University

Demet Çakır, Assistant Professor

Role: STUDY_CHAIR

Tokat Gaziosmanpasa University

Ayşenur Kahraman, Research Assistant

Role: STUDY_CHAIR

Tokat Gaziosmanpasa University

Emine Aksüt Akçay

Role: STUDY_CHAIR

Kahramanmaras Sütcü İmam Unıversity

Locations

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Tokat Gaziosmanpasa University

Tokat Province, Tokat Province, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Melek Şen Aytekin, Research Assistant Doctor

Role: CONTACT

+905071616044

Facility Contacts

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melek aytekin, Research Assistant Doctor

Role: primary

05071616044

Other Identifiers

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GaziosmanpasaU-EBE-MŞA-04

Identifier Type: -

Identifier Source: org_study_id

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