Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05960357 |
Other study ID # |
aybars2019 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
November 30, 2023 |
Est. completion date |
December 30, 2024 |
Study information
Verified date |
November 2023 |
Source |
Tarsus University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The aim of the study is to determine the state anxiety levels of the pregnant women who were
given and not given information about the fetus with USG images during the detailed
ultrasound (USG) and to compare them in both groups. This research is in the design of
pre-test-post-test applied and randomized controlled research. Dependent variables: State
anxiety levels Independent variables: Being informed during ultrasound Control variables:
Socio-demographic variables and obstetric variables.
Description:
The research population will be composed of pregnant women who applied to the perinatology
polyclinic of the Fırat University Hospital, Department of Obstetrics and Gynecology for
detailed USG. The sample size was calculated using the G*Power V. 3.1.9.7 program. According
to the results of 95% confidence (1-α), 95% test power (1-β), d=0.72 effect size and two-way
independent samples t test power analysis, 51 in each group, a total of at least 102 people
were sampled. was calculated (Ekrami et al., 2019).
Randomization
Pregnant women who are suitable for the sample selection criteria, using the Random Integer
Generator method under Numbers sub-title from Random.org, for the numbers distributed in 2
columns consisting of 1-102 numbers.
Which column would be the experiment and which column would be the control was determined by
drawing lots.
Pre-test-Post-test application
Before starting the detailed USG examination for the experimental group, Personal Information
Form and State-Anxiety Inventory (DCI) will be filled. While informing about the fetus during
the USG examination, the pregnant woman will be informed by using the physical images of the
fetus (hand, arm, face, heartbeat, information about the internal organs, etc.) using the USG
screen. After the USG is completed, the State-Anxiety Inventory (DCI) will be filled again as
a final test. In the control group, the Personal Information Form and State-Anxiety Inventory
(DCI) will be filled before the USG procedure, and only the State-Anxiety Inventory (DCI)
after the USG procedure. After the data collection process is completed, the pregnant woman
will be informed about the USG results.