The Effect of Wireless Fetal Monitoring System on Comfort, Pain and Satisfaction

Not Applicable

Completed

• Conditions: Pregnancy Related
• Interventions: Device: wireless fetal monitoring system

• Registration Number: NCT05778435
• Lead Sponsor: Tokat Gaziosmanpasa University

Brief Summary

Wireless EFM shortens labor duration, increases birth satisfaction, and reduces perceived pain during labor. With wireless EFM, comfort in labor increases and higher labor comfort increases birth satisfaction. As perceived pain in labor decreases, birth satisfaction increases. Therefore, wireless EFM practice is recommended during the antepartum and intrapartum periods.

Detailed Description

Problem Wired Electronic Fetal Monitoring (EFM) limits the woman's freedom of movement during labor, causes inability to cope with labor pain, lack of comfort, and a decrease in labor satisfaction.

Background While EFM is performed as wired and wireless in the antepartum and intrapartum periods, wired application is common in the world and in our country.

Aim This randomized controlled study was conducted to evaluate the effect of the wireless fetal monitoring, which is used during birth, on the woman's comfort, labor pain and birth satisfaction.

Methods The study population consisted of 88 women, divided into two groups the experimental group (n=44) and the control group (n=44). The data were collected with the Personal Information Form, Childbirth Comfort Questionnaire (CCQ), Visual Pain Scale (VAS), and Birth Satisfaction Scale-Revised (BSS-R). During the intrapartum period, the wireless fetal monitoring system was used in the experimental group and the wired fetal monitoring system was used in the control group.

Study Timeline

• Study Start: 2021-09-11
• Primary Completion: 2021-12-03
• Study Completion: 2021-12-03
• Study First Submitted: 2022-12-28
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-09
• Last Update Submitted: 2023-03-09
• Study First Posted: 2023-03-21
• Last Update Posted: 2023-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 88

Inclusion Criteria

• Pregnant women who are willing to participate in the study,
• Aged 18-40 years,
• Having a healthy pregnancy,
• With a gestational age of > 37+0 weeks,
• With a cervical dilatation of 4-5 cm,
• With a singleton pregnancy,
• With a live fetus,
• Can speak Turkish,
• Do not have comprehension, perception, and communication problems participated in the study.

Exclusion Criteria

• Pregnant women who did not comply with the study had communication problems,
• Had complications,
• Needed urgent cesarean delivery and wanted to withdraw from the study were excluded from the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
wireless fetal monitoring group	wireless fetal monitoring system	wireless fetal monitoring system was applied to the experimental group

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale	When the cervical dilatation of the pregnant woman was 8-10 cm in labor, the VAS were filled out by the researcher between contractions, when the pregnant feels good.	To measure the level of the pain, mostly a 10-cm-long vertical or horizontal line labeled from "No pain" to "Unbearable pain" is used. The participants are asked to mark their pain level on the line by a line, dot, or simply showing. The distance between the "no pain" point and the marked point indicates the level of pain
Birth Satisfaction Scale-Revised	The BSS-R was conducted 1 h after the mother was taken from the labor room to the gynecology and obstetrics service. The time required for the rest need of the postpartum mother, to meet her personal needs and breastfeed her baby was also provided	The lowest and the highest scores that can be obtained from the scale were 0 and 40, respectively. Higher scores indicate higher satisfaction. Satisfaction is classified as low satisfaction (0-13), medium satisfaction (14-27), and high satisfaction (28-40). The scale is implemented within the first three days after delivery birth.
Childbirth Comfort Questionnaire	When the cervical dilatation of the pregnant woman was 8-10 cm in labor, the CCQ were filled out by the researcher between contractions, when the pregnant feels good.	The participants rated the questionnaire through a Likert-type scale ranging from 1 to 5. The scores that can be obtained from the scale vary from 9 to 45. Higher scores indicate higher comfort during labor, whereas lower scores mean lower comfort

Trial Locations

Locations (1)

Cumhuriyet University; 🇹🇷 Sivas, Turkey