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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Birth; Intrapartum
• Intervention / Treatment: Other: Continuous Wireless EFM Group

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 112
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melek Şen Aytekin, Research Assistant Doctor; Phone Number: +905071616044; Email: meleksenaytekin@gmail.com

Study Locations

• Turkey (Türkiye)
  • Tokat Province
    • Tokat Province, Tokat Province, Turkey (Türkiye), 60000
      • Tokat Gaziosmanpasa University
      • Contact: melek aytekin, Research Assistant Doctor; Phone Number: 05071616044; Email: mlksn90@gmail.com
      • Principal Investigator: Melek Şen Aytekin, Research Assistant
      • Sub-Investigator: Demet Çakır, Assistant Professor
      • Sub-Investigator: Ayşenur Kahraman, Research Assistant
      • Sub-Investigator: Emine Aksüt Akçay, Assistant Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Birth Experience Questionnaire	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).	1 hour after the end of labor
The Visual Acuity Scale	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	Determining the pain level of pregnant women will be completed within 5 minutes when cervical dilation is 8-10 cm.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Personal Information Form	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.	The data will be collected 5 minutes after the pregnant woman is included in the study.

Collaborators and Investigators

• Sponsor: Tokat Gaziosmanpasa University
• Investigators: Principal Investigator: Melek Şen Aytekin, Research Assistant, Tokat Gaziosmanpasa University; Study Chair: Demet Çakır, Assistant Professor, Tokat Gaziosmanpasa University; Study Chair: Ayşenur Kahraman, Research Assistant, Tokat Gaziosmanpasa University; Study Chair: Emine Aksüt Akçay, Kahramanmaras Sutcu Imam Unıversity

Study record dates

Study Major Dates

• Study Start (Estimated): November 15, 2025
• Primary Completion (Estimated): January 15, 2026
• Study Completion (Estimated): January 15, 2026

Study Registration Dates

• First Submitted: October 2, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 18, 2025

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: pain; intrapartum; Fetal Monitoring; birth experience; Continuous Wireless Fetal Monitoring
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain
• Other Study ID Numbers: GaziosmanpasaU-EBE-MŞA-04

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