Obesity in PregnancyNCT07379307
EFFECT OF DİFFERENT POSİTİONS ON PAİN AND COMFORT DURİNG FETAL MONİTORİNG İN OBESE PREGNANT WOMEN
A study testing Maternal Positioning during NST in people with Obesity in Pregnancy and Maternal Comfort During Fetal Monitoring, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity in Pregnancy, Maternal Comfort During Fetal Monitoring
- What is being tested?
- Maternal Positioning during NST
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 2 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- No physical disabilities
- Able to speak Turkish to answer questions accurately
- No cognitive, comprehension, or communication difficulties
Who cannot join
- 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
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- Having physical disabilities affecting mobility, hearing, or psychological function
- Gestational age less than 28+0 weeks
- Currently in active labor
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tokat State Hospital, Department of Obstetrics and Gynecology, NST Room
Tokat Province, Tokat Province, 60100
About this study
Official title: 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.
Read the 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.
- Being tested
- Maternal Positioning during NST
- Keywords
- electronic fetal monitoring, maternal obesity, comfort, pain
- Medical subject headings
- Pregnancy in Obesity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal Positioning during NSTBehavioural
Also called Supported Left Lateral Position (Group 1), Supine Position (Group 2), Left Lateral without Support (Group 3)
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.
| Study group | Role | What they receive |
|---|---|---|
| Supported Left Lateral Position | Experimental | Participants underwent electronic fetal monitoring while lying in a supported left lateral position using pillows for positioning support. Receives: 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. Receives: Behavioral: Maternal Positioning during NST |
| Supine Position | Experimental | Participants underwent electronic fetal monitoring while lying in the supine (back-lying) position. Receives: Behavioral: Maternal Positioning during NST |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: Immediately after NST
Secondary outcomes (1)
General Comfort Scale Score
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.
Measured: Immediately after NST
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start1 Dec 2023
- Primary completion2 Feb 2024
- Study completion2 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, hatice melike, Tokat Gaziosmanpasa University
- Investigators
- demet çakır, Assistant Professor, Principal investigator, Tokat Gaziosmanpaşa University, Department of MidwiferyHatice melike evrin, Master's Student, Principal investigator, Tokat Gaziosmanpaşa University, Department of Midwifery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07379307
- Sponsor's protocol ID
- TUBITAK-2209A-1919B012309536
- Other IDs
- TUBITAK 2209-A
- Status last verified
- Jan 2026
- First submitted
- 23 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data from the Visual Analog Scale (VAS) and General Comfort Scale assessments will be shared, including participant age, gestational week, and body mass index (BMI). Data will be de-identified to protect participant privacy.
Publications
Evrin HM, Demet B; Effects of Maternal Position on Fetal Comfort during NST; Presented at the 2023 Kocaeli Midwifery Congress, Turkey; Unpublished
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF DİFFERENT MATERNAL POSİTİONS APPLİED DURİNG FETAL MONİTORİNG ON PAİN AND COMFORT LEVELS İN OBESE PREGNANT WOMEN
- ClinicalTrials.gov ID
- NCT07379307
- Acronym / sponsor ID
- TUBITAK-2209A-1919B012309536
- Keywords
- electronic fetal monitoring, maternal obesity, comfort, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 2 Feb 2024 (actual)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Supported Left Lateral Position | Experimental | Behavioral: Maternal Positioning during NSTParticipants underwent electronic fetal monitoring while lying in a supported left lateral position using pillows for positioning support. |
| Unsupported Left Lateral Position | Experimental | Behavioral: Maternal Positioning during NSTParticipants underwent electronic fetal monitoring while lying in an unsupported left lateral position without additional positioning aids. |
| Supine Position | Experimental | Behavioral: Maternal Positioning during NSTParticipants underwent electronic fetal monitoring while lying in the supine (back-lying) position. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maternal Positioning during NSTAlso: Supported Left Lateral Position (Group 1), Supine Position (Group 2), Left Lateral without Support (Group 3)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. | Behavioural | Supine Position, Supported Left Lateral Position, Unsupported Left Lateral Position |
Primary outcome
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."
1 secondary outcome
General Comfort Scale Score
Time frame: Immediately after NST
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Results publicationEvrin HM, Demet B; Effects of Maternal Position on Fetal Comfort during NST; Presented at the 2023 Kocaeli Midwifery Congress, Turkey; Unpublished
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data from the Visual Analog Scale (VAS) and General Comfort Scale assessments will be shared, including participant age, gestational week, and body mass index (BMI). Data will be de-identified to protect participant privacy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
demet çakır, Assistant Professor principal investigator
Tokat Gaziosmanpaşa University, Department of Midwifery
Hatice melike evrin, Master's Student principal investigator
Tokat Gaziosmanpaşa University, Department of Midwifery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maternal Positioning during NST in people with Obesity in Pregnancy and Maternal Comfort During Fetal Monitoring, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Comfort during NST (time frame: Immediately after NST). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07379307, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.