The Effect of Nonstress Test Device Noise Level on Stress Parameters in Primiparous Pregnant Women

Stress Clinical Trial

Official title:

The Effect of Nonstress Test Device Noise Level on Stress Parameters in Primiparous Pregnant Women

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05488704
• Other study ID #: 35620
• Status: Active, not recruiting
• Start date: February 1, 2021
• Est. completion date: July 28, 2028

Study information

• Verified date: August 2022
• Source: Halic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 44
• Est. completion date: July 28, 2028
• Est. primary completion date: October 1, 2021
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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,

• 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.

Exclusion Criteria:

• Pregnant women whose contractions are detected during the NST procedure,

• Pregnant women with deceleration detected in the NST procedure were excluded from the study.

Related Conditions & MeSH terms

• Noise Exposure
• Pregnancy Related
• Prenatal Care Late
• Prenatal Stress
• Stress

Intervention

Diagnostic Test:
• Stress Parameters Measurement
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

Locations

Country	Name	City	State
Turkey	Bakirköy Dr. Sadi Konuk Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Halic University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	01.02.2021-01.10.2021
Primary	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.	01.02.2021-01.10.2021