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

March 9, 2023 updated by: Demet Cakir, Tokat Gaziosmanpasa University

The Effect Of The Wireless Fetal Monitoring Used During Birth On The Women's Comfort, Labour Pain And Birth Satisfaction

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Sivas, Turkey, 58140
        • Cumhuriyet University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: wireless fetal monitoring group
wireless fetal monitoring system was applied to the experimental group
Device: 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.
No Intervention: Control group
Standard wired fetal monitoring system was applied to the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Childbirth Comfort Questionnaire
Time Frame: 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
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.
Visual Analogue Scale
Time Frame: 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
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.
Birth Satisfaction Scale-Revised
Time Frame: 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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tokat Gaziosmanpasa University

Investigators

  • Principal Investigator: Gülseren Dağlar, Cumhuriyet University
  • Principal Investigator: Demet Çakır, Cumhuriyet University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2021

Primary Completion (Actual)

December 3, 2021

Study Completion (Actual)

December 3, 2021

Study Registration Dates

First Submitted

December 28, 2022

First Submitted That Met QC Criteria

March 9, 2023

First Posted (Actual)

March 21, 2023

Study Record Updates

Last Update Posted (Actual)

March 21, 2023

Last Update Submitted That Met QC Criteria

March 9, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TRTOKAT60

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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