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

Primary Purpose

Ultrasound, Perinatal Care, Anxiety

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
To inform
Sponsored by
Tarsus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Ultrasound focused on measuring Ultrasound, Perinatal care, To inform, Consultancy, Anxiety

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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: -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Informed group during Ultrasound Examination

    Control group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    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).

    Full Information

    First Posted
    July 14, 2023
    Last Updated
    July 21, 2023
    Sponsor
    Tarsus University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05960357
    Brief Title
    State Anxiety Levels of Pregnant Women to Inform About Fetus With Ultrasound Images During Detailed Ultrasound.
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 30, 2023 (Anticipated)
    Primary Completion Date
    November 30, 2023 (Anticipated)
    Study Completion Date
    December 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tarsus University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ultrasound, Perinatal Care, Anxiety
    Keywords
    Ultrasound, Perinatal care, To inform, Consultancy, Anxiety

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    102 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Informed group during Ultrasound Examination
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    To inform
    Intervention Description
    It includes providing all necessary information about the fetus to the pregnant woman by using the ultrasound monitor during the detailed ultrasound.
    Primary Outcome Measure Information:
    Title
    Personal Information Form
    Description
    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).
    Time Frame
    through study completion, an average of 1 year
    Secondary Outcome Measure Information:
    Title
    State-Anxiety Inventory
    Description
    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).
    Time Frame
    through study completion, an average of 1 year

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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: -

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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