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

NCT05488704 | Active Not Recruiting

• 1 other identifier: 35620
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Adrenocorticotropic Hormone; Pregnancy; Noise; Prenatal Care

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (4)

CONTROL GROUP

Control Group \[NST device volume turned off\]

Diagnostic Test: Stress Parameters Measurement

Intervention Group I

Intervention Group I \[NST device volume 1-35 dB(A)\]

Diagnostic Test: Stress Parameters Measurement

Intervention Group II

Intervention Group II \[NST device volume 36-60 dB(A)\]

Diagnostic Test: Stress Parameters Measurement

Intervention Group III

Intervention Group III \[61 dB( A) and above\]

Diagnostic Test: Stress Parameters Measurement

Interventions

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

CONTROL GROUP; Intervention Group I; Intervention Group II; Intervention Group III

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Only pregnant women were included in the study.
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Voluntarily agreeing to participate in the research,
• Over 18 years old,
• Literate,
• Fluent in Turkish
• 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.

You may not qualify if:

• Pregnant women whose contractions are detected during the NST procedure,
• Pregnant women with deceleration detected in the NST procedure were excluded from the study.

Sponsors & Collaborators

• Halic University: lead

Study Sites (1)

Bakırköy Dr. Sadi Konuk Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 38178318 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Saliva Cortisol and Saliva ACTH samples were taken to measure the stress levels of pregnant women.

Study Officials

• Ayşenur Turan, PhD

  Lecturer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: August 4, 2022
• Study Start: February 1, 2021
• Primary Completion: October 1, 2021
• Study Completion (Estimated): July 28, 2028
• Last Updated: August 4, 2022

Record last verified: 2022-08

Locations

TU (1)