The Effect of Wireless Electronic Fetal Monitoring on Labor Pain and Birth Experiences
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age19-35
SponsorTokat Gaziosmanpasa University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Continuous Wireless EFM Group
Other interventionPregnant 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.
Treatment groups
112 Participants
are divided into 2 treatment groupsGroup A: Continuous Wired EFM GroupNo intervention 0 interventions
Group B: Continuous Wireless EFM GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
1 hour after the end of labor2
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
Time frame
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
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.
Time frame
The data will be collected 5 minutes after the pregnant woman is included in the study.Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: