StressNCT05488704
The Effect of Nonstress Test Device Noise Level on Stress Parameters in Primiparous Pregnant Women
An observational study of Stress and Noise Exposure, run by Halic University at 1 site in Turkey (Türkiye).
Trial summary
Introduction: Prenatal tests can increase the stress levels of pregnant women. One of the tests performed to evaluate fetal health during pregnancy is the Nonstress Test (NST). Objective: To evaluate the effect of NST device noise level on stress parameters in primiparous pregnant women. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Stress, Noise Exposure, Prenatal Stress
- What is being tested?
- Stress Parameters Measurement
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2021to 28 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- Women only
- Adult
Study population: It was decided to make the minimum sample size required in the study by power analysis, taking into account the differences of the pre-test and post-test variables, which are the primary results. More than 2 groups analysis (ANOVA) test in repeated measurements in the calculation, effect size: 0.25, type 1 error rate (α)=0.05, power of the study (1- β) was 0.80 (Type II error= 0.20). Accordingly, the minimum number of samples to be reached was calculated as 40 in total, and the study was completed with 44 samples, taking into account the 10% risk of loss.
Who may be able to join
- Voluntarily agreeing to participate in the research,
- Over 18 years old,
- Literate,
- Fluent in Turkish
- 32-42 of your pregnancy. in the week,
- Having a healthy pregnancy,
Show all 13Show fewer
- No adrenal insufficiency,
- No problems with hearing,
- No psychiatric diagnosis during or before pregnancy,
- No history of infertility,
- Coming to routine pregnancy and NST control,
- Have not had any food or drink for at least two hours before the procedure,
- Primiparous pregnant women without contractions were included.
Who cannot join
- Pregnant women whose contractions are detected during the NST procedure,
- Pregnant women with deceleration detected in the NST procedure were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakırköy Dr. Sadi Konuk Training and Research Hospital
Istanbul
About this study
Introduction: Prenatal tests can increase the stress levels of pregnant women. One of the tests performed to evaluate fetal health during pregnancy is the Nonstress Test (NST).
Objective: To evaluate the effect of NST device noise level on stress parameters in primiparous pregnant women.
Read more
Method: A randomized controlled, prospective study was conducted with 44 pregnant women in a State Hospital in Istanbul/Turkey between 01.02.2021 and 01.10.2021.
Personal Information Form, Spielberger State Anxiety Inventory, Hillrom Welch Allyn Connex Spot Monitor, Gluco Dr Glucometer, Extech SL 400 Personal Noise Dosimeter, Sennheiser HD 450BT ANC Over-Ear Bluetooth Headset, Eppendorf Tube, Philips Avalon FM20 NST were used to collect data. A p value of <.05 was considered significant in the statistical evaluation.
Read the detailed description
A number of tests are used to evaluate fetal health during pregnancy. One of these tests is the NST. NST is a frequently used fetal evaluation method in gynecology clinics/services during pregnancy and labor. The sound levels of the NST device are created in a way that the healthcare professional can adjust, and at the same time, the average dB(A) range of the sound levels is not known. It has been stated in many studies that noise causes stress in individuals, and that the stress experienced in pregnant women is associated with negative maternal and neonatal outcomes. It is important to evaluate NST noise levels and stress parameters in order to maintain NST, which is a frequently used fetal evaluation method in the prenatal period in clinical practice, without causing maternal stress and to prevent possible negative consequences. With the information to be obtained in line with the results of the research, it is aimed to maintain the noise level of the NST device used by the midwives in the most appropriate sound range for the pregnant women and thus to ensure that the stress levels of the pregnant women are at the lowest level during the procedure.
This study was carried out to evaluate the effect of NST device noise level on stress parameters in primiparous pregnant women.
- Conditions
- Stress, Noise Exposure, Prenatal Stress, Prenatal Care Late, Pregnancy Related
- Being tested
- Stress Parameters Measurement
- Keywords
- Adrenocorticotropic Hormone, Pregnancy, Noise, Prenatal Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress Parameters MeasurementDiagnostic test
Pre-Test (0-2 minutes before NST starts) - Measurement of vital parameters (Pre-Test)
- Glucose measurement
- Taking Salivary Cortisol and Saliva ACTH samples
- Filling the Spielberger State Anxiety Inventory
- Starting NST by controlling the noise level Interim Test-(NST 10th minute) - Measurement of vital parameters (Intermediate Test)
- Taking Salivary Cortisol and Saliva ACTH samples
- Filling the Spielberger State Anxiety Inventory
- Termination of NST after 20 minutes Final Test(within 0-2 minutes after NST is over)
- Measurement of vital parameters
- Glucose measurement
- Taking Salivary Cortisol and Saliva ACTH samples
- Filling the Spielberger State Anxiety Inventory After Data Collection - Recording of data
- Centrifugation and analysis of saliva samples taken
| Study group | Role | What they receive |
|---|---|---|
| CONTROL GROUP | Control Group [NST device volume turned off] Receives: Diagnostic Test: Stress Parameters Measurement | |
| Intervention Group I | Intervention Group I [NST device volume 1-35 dB(A)] Receives: Diagnostic Test: Stress Parameters Measurement | |
| Intervention Group II | Intervention Group II [NST device volume 36-60 dB(A)] Receives: Diagnostic Test: Stress Parameters Measurement | |
| Intervention Group III | Intervention Group III [61 dB( A) and above] Receives: Diagnostic Test: Stress Parameters Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Does increasing the noise level of the NST device affect If salivary cortisol levels
Data collection tool used to reach this outcome: Saliva cortisol was measured by a microplate reader with commercially available kit based on ELISA.
Measured: 01.02.2021-01.10.2021
Does increasing the noise level of the NST device affect If salivary ACTH levels
Data collection tool used to reach this outcome: Saliva ACTH was measured by a microplate reader with commercially available kit based on ELISA.
Measured: 01.02.2021-01.10.2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start1 Feb 2021
- Primary completion1 Oct 2021
- Study completion28 Jul 2028 (estimated)
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 StressStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayşenur Turan, PhD, Study director, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488704
- Sponsor's protocol ID
- 35620
- Status last verified
- Aug 2022
- First submitted
- 26 Jul 2022
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.
Publications
Aysenur T, Nuran G, Cihan K, Huri B. The Effect of Nonstress Device Noise Level on Stress Parameters in Primigravid Women: A Randomized Controlled Trial. J Midwifery Womens Health. 2024 Mar-Apr;69(2):279-286. doi: 10.1111/jmwh.13581. Epub 2024 Jan 4.
PubMed 38178318
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nonstress Test Device Noise Level on Stress Parameters in Primiparous Pregnant Women
- ClinicalTrials.gov ID
- NCT05488704
- Acronym / sponsor ID
- 35620
- Conditions
- Stress, Noise Exposure, Prenatal Stress, Prenatal Care Late, Pregnancy Related
- Keywords
- Adrenocorticotropic Hormone, Pregnancy, Noise, Prenatal Care
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 28 Jul 2028 (estimated)
- First posted
- 4 Aug 2022 (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.
Introduction: Prenatal tests can increase the stress levels of pregnant women. One of the tests performed to evaluate fetal health during pregnancy is the Nonstress Test (NST).
Objective: To evaluate the effect of NST device noise level on stress parameters in primiparous pregnant women.
Method: A randomized controlled, prospective study was conducted with 44 pregnant women in a State Hospital in Istanbul/Turkey between 01.02.2021 and 01.10.2021.
Personal Information Form, Spielberger State Anxiety Inventory, Hillrom Welch Allyn Connex Spot Monitor, Gluco Dr Glucometer, Extech SL 400 Personal Noise Dosimeter, Sennheiser HD 450BT ANC Over-Ear Bluetooth Headset, Eppendorf Tube, Philips Avalon FM20 NST were used to collect data. A p value of <.05 was considered significant in the statistical evaluation.
Detailed description
A number of tests are used to evaluate fetal health during pregnancy. One of these tests is the NST. NST is a frequently used fetal evaluation method in gynecology clinics/services during pregnancy and labor. The sound levels of the NST device are created in a way that the healthcare professional can adjust, and at the same time, the average dB(A) range of the sound levels is not known. It has been stated in many studies that noise causes stress in individuals, and that the stress experienced in pregnant women is associated with negative maternal and neonatal outcomes. It is important to evaluate NST noise levels and stress parameters in order to maintain NST, which is a frequently used fetal evaluation method in the prenatal period in clinical practice, without causing maternal stress and to prevent possible negative consequences. With the information to be obtained in line with the results of the research, it is aimed to maintain the noise level of the NST device used by the midwives in the most appropriate sound range for the pregnant women and thus to ensure that the stress levels of the pregnant women are at the lowest level during the procedure.
This study was carried out to evaluate the effect of NST device noise level on stress parameters in primiparous pregnant women.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CONTROL GROUP | – | Diagnostic Test: Stress Parameters MeasurementControl Group [NST device volume turned off] |
| Intervention Group I | – | Diagnostic Test: Stress Parameters MeasurementIntervention Group I [NST device volume 1-35 dB(A)] |
| Intervention Group II | – | Diagnostic Test: Stress Parameters MeasurementIntervention Group II [NST device volume 36-60 dB(A)] |
| Intervention Group III | – | Diagnostic Test: Stress Parameters MeasurementIntervention Group III [61 dB( A) and above] |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- It was decided to make the minimum sample size required in the study by power analysis, taking into account the differences of the pre-test and post-test variables, which are the primary results. More than 2 groups analysis (ANOVA) test in repeated measurements in the calculation, effect size: 0.25, type 1 error rate (α)=0.05, power of the study (1- β) was 0.80 (Type II error= 0.20). Accordingly, the minimum number of samples to be reached was calculated as 40 in total, and the study was completed with 44 samples, taking into account the 10% risk of loss.
Key inclusion criteria (13 listed)
- Voluntarily agreeing to participate in the research,
- Over 18 years old,
- Literate,
- Fluent in Turkish
- 32-42 of your pregnancy. in the week,
Key exclusion criteria (2 listed)
- Pregnant women whose contractions are detected during the NST procedure,
- Pregnant women with deceleration detected in the NST procedure were excluded from the study.
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 |
|---|---|---|
| Stress Parameters MeasurementPre-Test (0-2 minutes before NST starts) - Measurement of vital parameters (Pre-Test) * Glucose measurement * Taking Salivary Cortisol and Saliva ACTH samples * Filling the Spielberger State Anxiety Inventory • Starting NST by controlling the noise level Interim Test-(NST 10th minute) - Measurement of vital parameters (Intermediate Test) * Taking Salivary Cortisol and Saliva ACTH samples * Filling the Spielberger State Anxiety Inventory • Termination of NST after 20 minutes Final Test(within 0-2 minutes after NST is over) * Measurement of vital parameters * Glucose measurement * Taking Salivary Cortisol and Saliva ACTH samples * Filling the Spielberger State Anxiety Inventory After Data Collection - Recording of data * Centrifugation and analysis of saliva samples taken | Diagnostic test | CONTROL GROUP, Intervention Group I, Intervention Group II, Intervention Group III |
Primary outcome
Does increasing the noise level of the NST device affect If salivary cortisol levels
Time frame: 01.02.2021-01.10.2021
Data collection tool used to reach this outcome: Saliva cortisol was measured by a microplate reader with commercially available kit based on ELISA.
Does increasing the noise level of the NST device affect If salivary ACTH levels
Time frame: 01.02.2021-01.10.2021
Data collection tool used to reach this outcome: Saliva ACTH was measured by a microplate reader with commercially available kit based on ELISA.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Derived from this study: PubMed 38178318Aysenur T, Nuran G, Cihan K, Huri B. The Effect of Nonstress Device Noise Level on Stress Parameters in Primigravid Women: A Randomized Controlled Trial. J Midwifery Womens Health. 2024 Mar-Apr;69(2):279-286. doi: 10.1111/jmwh.13581. Epub 2024 Jan 4.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available.
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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.
Ayşenur Turan, PhD study director
Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress and Noise Exposure, run by Halic 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 13 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 4 Aug 2022. 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?
This study is still under way. Results are not available in the source record yet.
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?
Does increasing the noise level of the NST device affect If salivary cortisol levels (time frame: 01.02.2021-01.10.2021). The study lists 2 primary outcomes in all. 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 NCT05488704, 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 4 Aug 2022.