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Active Not RecruitingNCT05488704

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

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
44 (actual)
Sponsor
Halic University · Academic / Other
Sex
Female
Age
18 Years – 45 Years
Healthy volunteers

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTStress 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

Timeline

Start date
2021-02-01
Primary completion
2021-10-01
Completion
2028-07-28
First posted
2022-08-04
Last updated
2022-08-04

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT05488704. Inclusion in this directory is not an endorsement.