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

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05778435
• Other study ID #: TRTOKAT60
• Status: Completed
• Phase: N/A
• Start date: September 11, 2021
• Est. completion date: December 3, 2021

Study information

• Verified date: March 2023
• Source: Tokat Gaziosmanpasa University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 3, 2021
• Est. primary completion date: December 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

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.

Locations

Country	Name	City	State
Turkey	Cumhuriyet University	Sivas

Sponsors (1)

Lead Sponsor	Collaborator
Tokat Gaziosmanpasa University

Country where clinical trial is conducted

Turkey, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Childbirth Comfort Questionnaire	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.
Primary	Visual Analogue Scale	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.
Primary	Birth Satisfaction Scale-Revised	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