- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05686694
Pregnancy on Oral Glucose Tolerance Test Implementation Status, Knowledge, and Anxiety Level
The Effect of Video Education Given on Pregnancy on Oral Glucose Tolerance Test Implementation Status, Knowledge, and Anxiety Level
Study Overview
Detailed Description
Hypothesis; H0: There is no difference between the OGTT knowledge level scores of primiparous pregnant women who received and did not receive video education.
H1: There is a difference between the OGTT knowledge level scores of primiparous pregnant women who received and did not receive video education.
H0: There is no difference between the status of having the OGTT, primiparous pregnant women who received and did not receive video education.
H1: There is a difference between the status of having the OGTT, primiparous pregnant women who received and did not receive video education.
H0: There is no difference between the mean scores of the State Anxiety Scale according to the video education status of the primiparous pregnant women who had OGTT.
H1: There is a difference between the mean scores of the State Anxiety Scale according to the video education status of the primiparous pregnant women who had OGTT.
H1: The anxiety level of pregnant women who had OGTT was lower than those who did not receive video education.
The research was planned as a single-blind randomized controlled experimental study. The homogeneity of the pregnant women in the education and control groups will be ensured according to age, education level and Instagram usage time. Considering the inclusion and exclusion criteria of the study, pregnant women will be divided into education and control groups by stratified randomization method. For this purpose, pregnant women who meet the criteria of the study will be assigned to the training and control group using a computer-assisted randomization program (https://www.random.org/). Pregnant women will not be informed about the groups they are in, and only the researcher will know which group they will be in, and single-blindness will be provided.
Dependent Variables The OGTT knowledge level of the pregnant women, their OGTT implementation status and the State Anxiety Inventory score average constitute the dependent variables of the study.
Independent variables The planned video OGTT training given to primiparous pregnant women constitutes the independent variable of the study.
Intermediate Variables Socio-demographic characteristics of pregnant women (age, occupation, marital status, family type, place of residence for the longest time, education level, income status, husband's occupation, husband's education level, husband's income), obstetric characteristics (gestational week, height, pregnancy Weight gained, family history of diabetes, history of miscarriage, presence of polycystic ovary syndrome), level of OGTT knowledge (the status of receiving information about OGTT, the people from whom they received information, the sufficient amount of information) constitute the intermediate variables of the research.
Informed Consent Form,Questionnaire for Descriptive Characteristics of Pregnants,Intention and Status of OGTT Questionnaire, Knowledge Level Form on Gestational Diabetes and Oral Glucose Tolerance Test (OGTT),State Anxiety Scale, Education Video Evaluation Form (for pilot group), Nickname card will be used in this study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey, 34453
- Sağlık Bilimleri Üniversitesi Sarıyer Hamidiye Etfal Eğitim ve Araştırma Hastanesi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Reading and understanding Turkish
- literate
- over 18 years old
- under 35 years old
- primiparous pregnant
- before 24 weeks of pregnancy
- having a computer or phone and able to access the internet
- using Instagram
- voluntarily agreed to participate in the study
Exclusion Criteria:
- have a diagnosis of chronic diabetes mellitus (DM)
- have an ectopic pregnancy,
- want to leave the study voluntarily,
- in the education group but do not watch all the education videos
- have miscarriage or preterm birth
- pregnant women who do not fill in the all forms in study
- cannot be contacted during the research
- who decide to continue their doctor's checkups in another hospital
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Education Group
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Sharing of Planned Education Videos on Instagram In this research, the platform where planned video education will be shared was determined as "Instagram", which is the most used social media platform by pregnant women.
In the Instagram user name "@ogttegitim" account, 6 education videos that will be created and shared.
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No Intervention: Control Group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Knowledge Level Form on the Pregnancy Diabetes and Oral Glucose Tolerance Test
Time Frame: before 24. pregnancy weeks and 30-34. pregnancy weeks
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Pregnant women will respond to each information sentence by choosing one of the options "True", "False", "I don't know".
It is planned that the form will consist of 25 or 30 items.
The state of knowing the items before and after the education will be evaluated with a percentage.
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before 24. pregnancy weeks and 30-34. pregnancy weeks
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State Anxiety Scale
Time Frame: 24-28. pregnancy weeks
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During the evaluation, a score between 1 (or -1) and 4 (or -4) is given for each item according to the positive or negative feature of the item, and the constant 50 is added to the total score to be obtained.
The highest score is 80 and the lowest score is 20.
The higher the total anxiety score, the higher the anxiety level of the person completing the inventory.
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24-28. pregnancy weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Özlem Demirel Bozkurt, Assoc. Prof., Ege University Nursing Faculty
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EGE-OZLEM-35
- Gülcan KARABULUT (Other Identifier: Ege University, Women Health Nursing, master degree student)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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