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NCT Number: NCT05488704

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Bakırköy Dr. Sadi Konuk Training and Research Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stress Parameters Measurement

Diagnostic 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

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Halic University

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2028
First posted
Aug 4, 2022
Registry last updated
Aug 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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