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Clinical Trials/NCT07379307
NCT07379307
Completed
Not Applicable

THE EFFECT OF DİFFERENT MATERNAL POSİTİONS APPLİED DURİNG FETAL MONİTORİNG ON PAİN AND COMFORT LEVELS İN OBESE PREGNANT WOMEN

Tokat Gaziosmanpasa University1 site in 1 country174 target enrollmentStarted: December 1, 2023Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Tokat Gaziosmanpasa University
Enrollment
174
Locations
1
Primary Endpoint
Maternal Comfort during NST

Overview

Brief Summary

This study was conducted to understand how different body positions during fetal monitoring affect pain and comfort in obese pregnant women. Fetal monitoring is a routine procedure used during pregnancy to check the baby's well-being. During this procedure, pregnant women are usually asked to lie still for a period of time, which may cause discomfort, especially for women with obesity.

The study included obese pregnant women in their third trimester who attended obstetrics outpatient clinics and underwent routine fetal monitoring. During the monitoring process, women were placed in one of three different positions: supported left side-lying, unsupported left side-lying, or lying on the back. Pain and comfort levels were assessed during and immediately after the fetal monitoring procedure.

The aim of this study was to determine which position provides greater comfort and less pain for obese pregnant women during fetal monitoring. The findings of this study may help health care professionals choose more comfortable positioning options and improve the overall pregnancy care experience for obese pregnant women.

Detailed Description

Fetal monitoring is a commonly used procedure during pregnancy to assess fetal well-being by recording the fetal heart rate and uterine activity. Although it is a routine and non-invasive procedure, remaining in the same position for an extended period of time may cause discomfort and pain, particularly in obese pregnant women. Maternal obesity is known to increase physical strain and may negatively affect comfort during clinical procedures.

This study was designed to evaluate the effects of different maternal positions applied during fetal monitoring on pain and comfort levels in obese pregnant women. The study was conducted with pregnant women who met the inclusion criteria and attended obstetrics outpatient clinics for routine fetal monitoring. Participants were assigned to one of three maternal positions during the monitoring process: supported left side-lying, unsupported left side-lying, or supine position.

During the fetal monitoring procedure, participants' pain and comfort levels were assessed using appropriate measurement methods. The primary focus of the study was to compare maternal comfort and pain perception across different positions during fetal monitoring. Understanding how positioning affects maternal comfort may contribute to improved clinical practices and enhance the quality of care provided to obese pregnant women during routine prenatal monitoring.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Masking Description

This is an open-label study. No participants, investigators, or outcome assessors were masked.

Eligibility Criteria

Ages
19 Years to 40 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Pregnant women who voluntarily agree to participate in the study
  • Aged between 19 and 40 years
  • Experiencing a healthy pregnancy
  • Gestational age between 28+0 and 40+0 weeks (only third-trimester pregnancies are included, as EFM monitoring is recommended after 27 weeks)
  • Singleton pregnancy with a live fetus
  • Body Mass Index (BMI) of 30 or higher
  • No physical disabilities
  • Able to speak Turkish to answer questions accurately
  • No cognitive, comprehension, or communication difficulties

Exclusion Criteria

  • Pregnant women who do not agree to participate in the study
  • Aged under 19 years or 41 years and above (adolescent and advanced-age pregnancies are excluded due to increased risk)
  • Diagnosed with high-risk pregnancy
  • Illiterate or unable to read/write
  • Having a contagious disease
  • Having a mental disorder or history of a mental disorder requiring treatment
  • Having physical disabilities affecting mobility, hearing, or psychological function
  • Gestational age less than 28+0 weeks
  • Currently in active labor

Arms & Interventions

Supported Left Lateral Position

Experimental

Participants underwent electronic fetal monitoring while lying in a supported left lateral position using pillows for positioning support.

Intervention: Maternal Positioning during NST (Behavioral)

Unsupported Left Lateral Position

Experimental

Participants underwent electronic fetal monitoring while lying in an unsupported left lateral position without additional positioning aids.

Intervention: Maternal Positioning during NST (Behavioral)

Supine Position

Experimental

Participants underwent electronic fetal monitoring while lying in the supine (back-lying) position.

Intervention: Maternal Positioning during NST (Behavioral)

Outcomes

Primary Outcomes

Maternal Comfort during NST

Time Frame: Immediately after NST

Maternal overall comfort during Non-Stress Test (NST) will be assessed using the General Comfort Scale (Short Form). The scale consists of 28 items evaluating three sub-dimensions: relief, ease, and transcendence. Each item is rated on a 6-point Likert scale, where 1 indicates low comfort and 6 indicates high comfort. The assessment will be conducted immediately after the NST while the participant remains in the assigned position (supported left lateral, supine, or left lateral without support). This measure evaluates the effect of maternal positioning on overall comfort during fetal monitoring."

Secondary Outcomes

  • General Comfort Scale Score(Immediately after NST)

Investigators

Sponsor
Tokat Gaziosmanpasa University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

hatice melike

Master's Student

Tokat Gaziosmanpasa University

Study Sites (1)

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