State Anxiety Levels of Pregnant Women to Inform About Fetus With Ultrasound Images During Detailed Ultrasound.

State Anxiety Levels of Pregnant Women Who Were Given or Not Given Information About the Fetus With Ultrasound Images During Detailed Ultrasound: A Randomized Controlled Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anxiety; Ultrasound; Perinatal Care
• Intervention / Treatment: Other: To inform

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18-23. in gestational week
• Not carrying any risk factors (pre-eclampsia, IUGG, premature rupture of membranes, getational diabetes, etc.) during pregnancy,
• Pregnant women who did not have any diagnosed problems related to the health of the fetus (such as fetal anomaly, intrauterine growth retardation) were included in the study.

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Informed group during Ultrasound Examination; Before starting the detailed USG examination for the experimental group, Personal Information Form and State-Anxiety Inventory 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 will be filled again as a final test.	Other: To inform; It includes providing all necessary information about the fetus to the pregnant woman by using the ultrasound monitor during the detailed ultrasound.
No Intervention: Control group; In the control group, the Personal Information Form and the State-Anxiety Inventory will be filled before the USG procedure, and only the State-Anxiety Inventory after the USG procedure. After the data collection process is completed, the pregnant woman will be informed about the USG results.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Personal Information Form	The Personal Information Form developed by the researchers consists of questions that determine some descriptive characteristics of pregnant women. (age, education level, employment status, income status, number of living children, number of pregnancies, current gestational week).	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
State-Anxiety Inventory	The Turkish validity and reliability study of the inventory developed by Spielberger et al. was performed by Öner and Le Compte (1983), and the Cronbach's alpha coefficient was found to be 0.83 (Öner & LeCompte, 1985). The 20-item scale consists of items describing how people feel under certain conditions at a certain time and their feelings about the situation they are in (For example, 'I am calm at the moment'). The scale consists of 4-point Likert-type responses as (1) not at all, (2) a little, (3) a lot, (4) completely. There are ten (items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20) reversed statements in the scale. The score obtained from the scale varies between 20 and 80. High scores on the scale indicate high anxiety, low scores indicate mild anxiety (Öner & LeCompte, 1985).	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Tarsus University

Study record dates

Study Major Dates

• Study Start (Estimated): November 30, 2023
• Primary Completion (Estimated): December 30, 2023
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: July 14, 2023
• First Submitted That Met QC Criteria: July 21, 2023
• First Posted (Actual): July 25, 2023

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Ultrasound; Anxiety; Perinatal care; To inform; Consultancy
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: aybars2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No