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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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07233187
Enrollment
112
Registered
2025-11-18
Start date
2025-11-15
Completion date
2026-01-15
Last updated
2025-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Birth, Intrapartum

Keywords

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

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.

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.

Interventions

OTHERContinuous 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.

Sponsors

Tokat Gaziosmanpasa University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 35 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Birth Experience Questionnaire1 hour after the end of laborThe 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).
The Visual Acuity ScaleDetermining 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

MeasureTime frameDescription
Personal Information FormThe 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactMelek Şen Aytekin, Research Assistant Doctor
meleksenaytekin@gmail.com+905071616044

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026