- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07379307
EFFECT OF DİFFERENT POSİTİONS ON PAİN AND COMFORT DURİNG FETAL MONİTORİNG İN OBESE PREGNANT WOMEN
THE EFFECT OF DİFFERENT MATERNAL POSİTİONS APPLİED DURİNG FETAL MONİTORİNG ON PAİN AND COMFORT LEVELS İN OBESE PREGNANT WOMEN
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tokat Province
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Tokat Province, Tokat Province, Turkey (Türkiye), 60100
- Tokat State Hospital, Department of Obstetrics and Gynecology, NST Room
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Supported Left Lateral Position
Participants underwent electronic fetal monitoring while lying in a supported left lateral position using pillows for positioning support.
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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.
Other Names:
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|
Experimental: Unsupported Left Lateral Position
Participants underwent electronic fetal monitoring while lying in an unsupported left lateral position without additional positioning aids.
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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.
Other Names:
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Experimental: Supine Position
Participants underwent electronic fetal monitoring while lying in the supine (back-lying) position.
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Maternal Comfort during NST
Time Frame: Immediately after NST
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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."
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Immediately after NST
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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General Comfort Scale Score
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.
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Immediately after NST
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: demet çakır, Assistant Professor, Tokat Gaziosmanpaşa University, Department of Midwifery
- Principal Investigator: Hatice melike evrin, Master's Student, Tokat Gaziosmanpaşa University, Department of Midwifery
Publications and helpful links
General Publications
- Evrin HM, Demet B; Effects of Maternal Position on Fetal Comfort during NST; Presented at the 2023 Kocaeli Midwifery Congress, Turkey; Unpublished
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Neurologic Manifestations
- Nutrition Disorders
- Female Urogenital Diseases and Pregnancy Complications
- Overnutrition
- Body Weight
- Pregnancy Complications
- Overweight
- Obesity
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Pain
- Pregnancy in Obesity
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Therapeutics
- Patient Care
- Health Services
- Health Care Facilities Workforce and Services
- Posture
- Palliative Care
- Supine Position
Other Study ID Numbers
- TUBITAK-2209A-1919B012309536
- TUBITAK 2209-A (Other Identifier: The Scientific and Technological Research Council of Turkey (TUBITAK))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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