Ignite Creation Date:
2025-12-24 @ 6:45 PM
Ignite Modification Date:
2026-01-04 @ 2:15 PM
Study NCT ID:
NCT05960357
Status:
COMPLETED
Last Update Posted:
2025-06-18
First Post:
2023-07-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
State Anxiety Levels of Pregnant Women to Inform About Fetus With Ultrasound Images During Detailed Ultrasound.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-15', 'studyFirstSubmitDate': '2023-07-14', 'studyFirstSubmitQcDate': '2023-07-21', 'lastUpdatePostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Personal Information Form', 'timeFrame': 'through study completion, an average of 1 year', '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).'}], 'secondaryOutcomes': [{'measure': 'State-Anxiety Inventory', 'timeFrame': 'through study completion, an average of 1 year', '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)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ultrasound', 'Perinatal care', 'To inform', 'Consultancy', 'Anxiety'], 'conditions': ['Ultrasound', 'Perinatal Care', 'Anxiety']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).\n\nRandomization\n\nPregnant 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.\n\nWhich column would be the experiment and which column would be the control was determined by drawing lots.\n\nPre-test-Post-test application\n\nBefore 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-23. in gestational week\n* Not carrying any risk factors (pre-eclampsia, IUGG, premature rupture of membranes, getational diabetes, etc.) during pregnancy,\n* 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.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05960357', 'briefTitle': 'State Anxiety Levels of Pregnant Women to Inform About Fetus With Ultrasound Images During Detailed Ultrasound.', 'organization': {'class': 'OTHER', 'fullName': 'Tarsus University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'aybars2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Informed group during Ultrasound Examination', '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.', 'interventionNames': ['Other: To inform']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', '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.'}], 'interventions': [{'name': 'To inform', 'type': 'OTHER', 'description': 'It includes providing all necessary information about the fetus to the pregnant woman by using the ultrasound monitor during the detailed ultrasound.', 'armGroupLabels': ['Informed group during Ultrasound Examination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33400', 'city': 'Mersin', 'state': 'Mersin', 'country': 'Turkey (Türkiye)', 'facility': 'Tarsus University', 'geoPoint': {'lat': 36.81196, 'lon': 34.63886}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tarsus University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Özlem KOÇ', 'investigatorAffiliation': 'Tarsus University'}}}}