Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07233187

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

19 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tokat Gaziosmanpasa University

Tokat Province, 60000, Turkey (Türkiye)

Location contact

Ayşenur Kahraman, Research Assistant

SUB_INVESTIGATOR

Demet Çakır, Assistant Professor

SUB_INVESTIGATOR

Emine Aksüt Akçay, Assistant Professor

SUB_INVESTIGATOR

Melek Şen Aytekin, Research Assistant

PRINCIPAL_INVESTIGATOR

melek aytekin, Research Assistant Doctor

CONTACT

[email protected]

05071616044

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Continuous Wireless EFM Group

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.

Primary outcomes

  1. Birth Experience Questionnaire

    Time frame: 1 hour after the end of labor

    The Birth Experience Questionnaire (CEQ), developed by Dencker and colleagues in 2010, was adapted into Turkish by Mamuk and colleagues in 2019. Developed to measure women's birth experiences across various dimensions, the scale has four subscales and 22 items. It consists of the following subscales: Birth Process (8 items), Professional Assistance/Support (5 items), Perceived Safety/Memories (6 items), and Participation in Decisions (3 items).

  2. The Visual Acuity Scale

    Time frame: Determining the pain level of pregnant women will be completed within 5 minutes when cervical dilation is 8-10 cm.

    This is a horizontal or vertical line, usually 10 cm long, used to assess pain intensity. It begins with "No Pain" and ends with "Unbearable Pain." The patient marks the appropriate location on this line based on the pain they experience. The VAS is used to convert some values that cannot be measured numerically into numerical values. The two extremes of the parameter to be evaluated are written at either end of a 100 mm line, and the patient is asked to indicate where their own condition aligns with this line by drawing a line, placing a dot, or pointing. For example, for pain, "No pain at all" is written at one end, and "Extreme pain at the other end," and the patient marks their current condition on this line. According to this scale, the patient is asked to rate whether they have pain or not, and if so, to rate it on a scale of 0-10. According to this score, pain intensity is considered mild pain at <3, moderate pain at 3-6, and severe pain at >6. The distance from the point of

Secondary outcomes

  1. Personal Information Form

    Time frame: The data will be collected 5 minutes after the pregnant woman is included in the study.

    This form, which questions the introductory characteristics of pregnant women, consists of a total of 23 questions, 6 of which are to determine the socio-demographic and obstetric characteristics of pregnant women, 8 questions to learn their obstetric information and 9 questions about birth experience.

Study contacts

Contact information is provided by the study sponsor or research team.

Melek Şen Aytekin, Research Assistant Doctor

CONTACT

[email protected]

+905071616044

Sponsors and collaborators

Lead sponsor

Tokat Gaziosmanpasa University

Other

Registry information

Official study title

The Effect of Continuous Wireless Fetal Monitoring During the Intrapartum Period on Labor Pain and Birth Experience: A Randomized Controlled Single-Blind Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.