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

June 15, 2025 updated by: Özlem KOÇ, Tarsus University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Mersin, Turkey, 33400
        • Tarsus University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Personal Information Form
Time Frame: through study completion, an average of 1 year
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
State-Anxiety Inventory
Time Frame: through study completion, an average of 1 year
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tarsus University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 25, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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