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

NCT07233187 | Not Yet Recruiting

• 1 other identifier: GaziosmanpasaU-EBE-MŞA-04
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Birth; Intrapartum

Keywords

Fetal Monitoring; intrapartum; pain; birth experience; Continuous Wireless Fetal Monitoring

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Personal Information Form

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

Study Arms (2)

Continuous Wired EFM Group

NO INTERVENTION

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.

Continuous Wireless EFM Group

EXPERIMENTAL

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

Interventions

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.

Continuous Wireless EFM Group

Eligibility Criteria

• Age: 19 Years - 35 Years
• Gender Eligibility Details: Since the study will be conducted with pregnant women in the intrapartum period, only women will be biologically eligible to be included in the study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tokat Gaziosmanpasa University: lead

Study Sites (1)

Tokat Gaziosmanpasa University

Tokat Province, Tokat Province, 60000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Melek Şen Aytekin, Research Assistant

  Tokat Gaziosmanpasa University

  PRINCIPAL INVESTIGATOR

• Demet Çakır, Assistant Professor

  Tokat Gaziosmanpasa University

  STUDY CHAIR

• Ayşenur Kahraman, Research Assistant

  Tokat Gaziosmanpasa University

  STUDY CHAIR

• Emine Aksüt Akçay

  Kahramanmaras Sütcü İmam Unıversity

  STUDY CHAIR

Central Study Contacts

Melek Şen Aytekin, Research Assistant Doctor

CONTACT

+905071616044; meleksenaytekin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Doctor

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: November 18, 2025
• Study Start: November 15, 2025
• Primary Completion: January 15, 2026
• Study Completion: January 15, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)