The Effect of Continuous Wireless Fetal Monitoring During the Intrapartum Period on Labor Pain and Birth Experience: A Randomized Controlled Single-Blind Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- Birth Experience Questionnaire
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to 35 Years (Adult)
- Sex
- Female
- Accepts 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.
Arms & Interventions
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.
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: Continuous Wireless EFM Group (Other)
Outcomes
Primary Outcomes
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).
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
- Personal Information Form(The data will be collected 5 minutes after the pregnant woman is included in the study.)
Investigators
Melek Şen Aytekin
Research Assistant Doctor
Tokat Gaziosmanpasa University