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

NCT ID: NCT05778435

Last Updated: 2023-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-11
• Study Completion Date: 2021-12-03

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.

Conditions

Pregnancy Related

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

wireless fetal monitoring group

wireless fetal monitoring system was applied to the experimental group

Group Type: EXPERIMENTAL

wireless fetal monitoring system

Intervention Type: DEVICE

The wireless fetal monitoring system shortens the period of labor by enabling the woman to be more mobile during the intrapartum period.

Control group

Standard wired fetal monitoring system was applied to the control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

wireless fetal monitoring system

The wireless fetal monitoring system shortens the period of labor by enabling the woman to be more mobile during the intrapartum period.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Tokat Gaziosmanpasa University

OTHER

Sponsor Role: lead

Responsible Party

Demet Cakir

Assist.Prof.Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gülseren Dağlar

Role: PRINCIPAL_INVESTIGATOR

Cumhuriyet University

Demet Çakır

Role: PRINCIPAL_INVESTIGATOR

Cumhuriyet University

Locations

Cumhuriyet University

Sivas, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

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Other Identifiers

TRTOKAT60

Identifier Type: -

Identifier Source: org_study_id