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

NCT05778435 | Completed

• 1 other identifier: TRTOKAT60
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related

Keywords

Pain; Birth; Chilbirth Satisfaction; Wireless Fetal Monitoring; Comfort

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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

Study Arms (2)

wireless fetal monitoring group

EXPERIMENTAL

wireless fetal monitoring system was applied to the experimental group

Device: wireless fetal monitoring system

Control group

NO INTERVENTION

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

Interventions

wireless fetal monitoring system DEVICE

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

wireless fetal monitoring group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tokat Gaziosmanpasa University: lead

Study Sites (1)

Cumhuriyet University

Sivas, 58140, Turkey (Türkiye)

Location

Related Publications (29)

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  BACKGROUND

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• Watson K, Mills TA, Lavender T. Experiences and outcomes on the use of telemetry to monitor the fetal heart during labour: findings from a mixed methods study. Women Birth. 2022 May;35(3):e243-e252. doi: 10.1016/j.wombi.2021.06.004. Epub 2021 Jul 2.

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• Harkey KT, Casale MB, Pantelopoulos AA, Zurcher MA. Assessing the clinical use of a novel, mobile fetal monitoring device. Obstetrics & Gynecology. 2014;123:55S.

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  PMID: 25622043 RESULT

• Knupp RJ, Andrews WW, Tita ATN. The future of electronic fetal monitoring. Best Pract Res Clin Obstet Gynaecol. 2020 Aug;67:44-52. doi: 10.1016/j.bpobgyn.2020.02.004. Epub 2020 Mar 19.

  PMID: 32299728 RESULT

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gülseren Dağlar

  Cumhuriyet University

  PRINCIPAL INVESTIGATOR

• Demet Çakır

  Cumhuriyet University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist.Prof.Dr.

Study Record Dates

• First Submitted: December 28, 2022
• First Posted: March 21, 2023
• Study Start: September 11, 2021
• Primary Completion: December 3, 2021
• Study Completion: December 3, 2021
• Last Updated: March 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)