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

Active, not recruiting

• Conditions: Noise Exposure; Prenatal Care Late; Pregnancy Related; Stress; Prenatal Stress
• Interventions: Diagnostic Test: Stress Parameters Measurement

• Registration Number: NCT05488704
• Lead Sponsor: Halic University

Brief 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.

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 Timeline

• Study Start: 2021-02-01
• Primary Completion: 2021-10-01
• Study First Submitted: 2022-07-26
• Status Verified: 2022-08
• Study First Submitted QC: 2022-08-03
• Last Update Submitted: 2022-08-03
• Study First Posted: 2022-08-04
• Last Update Posted: 2022-08-04
• Study Completion: 2028-07-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 44

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intervention Group II	Stress Parameters Measurement	Intervention Group II \[NST device volume 36-60 dB(A)\]
Intervention Group III	Stress Parameters Measurement	Intervention Group III \[61 dB( A) and above\]
Intervention Group I	Stress Parameters Measurement	Intervention Group I \[NST device volume 1-35 dB(A)\]
CONTROL GROUP	Stress Parameters Measurement	Control Group \[NST device volume turned off\]

Primary Outcome Measures

Name	Time	Method
Does increasing the noise level of the NST device affect If salivary cortisol levels	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	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.

Trial Locations

Locations (1)

Bakırköy Dr. Sadi Konuk Training and Research Hospital; 🇹🇷 Istanbul, Turkey