EFFECT OF DİFFERENT POSİTİONS ON PAİN AND COMFORT DURİNG FETAL MONİTORİNG İN OBESE PREGNANT WOMEN

NCT07379307 | Completed DMC

• 2 other identifiers: TUBITAK-2209A-1919B012309536TUBITAK 2209-A
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

Maternal Comfort During Fetal Monitoring; Obesity in Pregnancy

Keywords

electronic fetal monitoring; maternal obesity; comfort; pain

Outcome Measures

Primary Outcomes (1)

• Maternal Comfort during 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."

  Immediately after NST

Secondary Outcomes (1)

• General Comfort Scale Score

  Immediately after NST

Study Arms (3)

Supported Left Lateral Position

EXPERIMENTAL

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

Behavioral: Maternal Positioning during NST

Unsupported Left Lateral Position

EXPERIMENTAL

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

Behavioral: Maternal Positioning during NST

Supine Position

EXPERIMENTAL

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

Behavioral: Maternal Positioning during NST

Interventions

Maternal Positioning during NST BEHAVIORAL

This intervention involves placing pregnant women at 28-40 weeks of gestation in specific positions (supported left lateral, supine, or left lateral without support) during Non-Stress Test (NST) monitoring. Each participant remains in the assigned position for 20-40 minutes while fetal heart rate is recorded using EFM. Pain/discomfort and overall comfort are assessed using Visual Analog Scale (VAS) and General Comfort Scale immediately after the intervention. The intervention is distinguished from other studies by the randomized allocation of three positional groups and simultaneous evaluation of maternal comfort and fetal monitoring outcomes.

Also known as: Supported Left Lateral Position (Group 1), Supine Position (Group 2), Left Lateral without Support (Group 3)

Supine Position; Supported Left Lateral Position; Unsupported Left Lateral Position

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tokat Gaziosmanpasa University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Tokat State Hospital, Department of Obstetrics and Gynecology, NST Room

Tokat Province, Tokat Province, 60100, Turkey (Türkiye)

Location

Related Publications (1)

• Evrin HM, Demet B; Effects of Maternal Position on Fetal Comfort during NST; Presented at the 2023 Kocaeli Midwifery Congress, Turkey; Unpublished

  RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Pregnancy in Obesity; Pain

Interventions

Supine Position; Palliative Care

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• demet çakır, Assistant Professor

  Tokat Gaziosmanpaşa University, Department of Midwifery

  PRINCIPAL INVESTIGATOR

• Hatice melike evrin, Master's Student

  Tokat Gaziosmanpaşa University, Department of Midwifery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. No participants, investigators, or outcome assessors were masked.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's Student

Model Details: Participants were assigned to one of three parallel groups. Each participant underwent fetal monitoring in a single maternal position. Pain and comfort levels were assessed during the monitoring procedure, and outcomes were compared between groups.

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: January 30, 2026
• Study Start: December 1, 2023
• Primary Completion: February 2, 2024
• Study Completion: February 2, 2024
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: De-identified IPD and supporting information will be available from March 1, 2026, for a period of 2 years, upon reasonable request.
• Access Criteria: De-identified individual participant data (VAS scores, General Comfort Scale results, age, gestational week, BMI) along with study protocol, informed consent form, and data dictionary/codebook will be available to other researchers upon reasonable request. Access will be granted after approval by the study principal investigator via secure data sharing platform or email.

Locations

TU (1)