Pregnancy on Oral Glucose Tolerance Test Implementation Status, Knowledge, and Anxiety Level

Gestational Diabetes Clinical Trial

Official title:

The Effect of Video Education Given on Pregnancy on Oral Glucose Tolerance Test Implementation Status, Knowledge, and Anxiety Level

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05686694
• Other study ID #: EGE-OZLEM-35
• Secondary ID: Gülcan KARABULUT
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: November 15, 2024

Study information

• Verified date: February 2024
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was planned to examine the effect of video education on pregnancy for oral glucose tolerance test implementation status, knowledge and anxiety level. The research was planned as a single-blind randomized controlled experimental study.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 140
• Est. completion date: November 15, 2024
• Est. primary completion date: October 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes

Intervention

Other:
• Video Education
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.

Locations

Country	Name	City	State
Turkey	Saglik Bilimleri Üniversitesi Sariyer Hamidiye Etfal Egitim ve Arastirma Hastanesi	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knowledge Level Form on the Pregnancy Diabetes and Oral Glucose Tolerance Test	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.	before 24. pregnancy weeks and 30-34. pregnancy weeks
Primary	State Anxiety Scale	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.	24-28. pregnancy weeks